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FP58-FR-04 Clinical profile of the novel oral CGRP receptor antagonist telcagepant for the acute treatment of migraine in phase 3 studies
19th World Congress of Neurology, Free Paper Abstracts / Journal of the Neurological Sciences 285 S1 (2009) S57–S154
well as demographic and socio-economic characteristics of the participants by a population based study. Method: This nationwide, home based prevalence study was done in 21 cities presenting all geographical regions of Turkey. Total 5323 households, aged between 18–65 years, were interviewed by using a structured interview form and examined for headache by specially trained 33 physicians. Interview form included diagnostic questions based on ICH-2 criteria for migraine, features of headache and associated symptoms, demographic and socioeconomic information, information about previous physician visits for headache, previous headache diagnoses, acute and prophylactic medication for headache, and access to headache medication. Results: Of 5323 participants (48.8% women and 51.2% men, mean age 35.9±12 years), 2376 reported having headaches during last one year and 871 were diagnosed as migraine. Migraine prevalence was estimated as 16.4% (8.5% in men and 24.6% in women). While 68.3% of migraineurs reported 3 or more migraine attacks in a month and 54.2% had usually severe headaches, only 4.9% were on propylactic treatment at present. Conclusions: The prevalence of migraine estimated as 16.4% in this study was similar to one of previous population based study done on 15–55 years old households which is 16.4%. However, in present study, women/men ratio (2.89) was higher than before. Lower rates of migraineurs on prophylactic treatment than expected was remarkable. FP58-FR-02 Plasma concentrations of ischemia-modified albumin in migraine patients S. Michalak1 , E. Wysocka2 , D. Wegrzyn3 , L. Torlinski2 , W. Kozubski3 . 1 Department of Neurochemistry and Neuropathology, Poznan University of Medical Sciences, Poznan, Poland; 2 Department of Clinical Biochemistry and Laboratory Medicine, Poznan University of Medical Sciences, Poznan, Poland; 3 Department of Neurology, Poznan University of Medical Sciences, Poznan, Poland Purpose: Ischemia-modified albumin (IMA) is a sensitive marker of myocardial ischemia and may be affected by ischemia occurring in other tissues. Migraine has been reported as a risk factor of ischemic stroke or cardiovascular events. Dysfunction of endothelial cells, as well as association with arteriopathies was evidenced in migraine patients. Cortical spreading depression-related oligemia, intracerebral large vessels spasm and endothelium-related hypercoagulability may cause ischemia in migraine patients. The aim of this study was to evaluate plasma levels of IMA in migraine patients during interictal period. Method: Fifty two migraineurs aged 37.9±9.6 yrs fulfilling IHS criteria for migraine were included in the study. The control group included 39 healthy volunteers aged 38.9±7.0 yrs. In all subjects neurological examination was carried on, as well as clinimetric evaluation with the use of: MIDAS, MIGSEV, QVM, VAS and VRS. Ischemia-modified albumin was evaluated by means of spectrophotometric method with the use of cobalt chloride. The IMA levels were expressed in optical density (O.D.) units. Results: Plasma concentrations of IMA were significantly (p = 0.0104) higher in migraine patients (median: 0.0841, interquartile range: 0.0000 to 0.3250 O.D.) than in controls (median: 0.0000, interquartile range: 0.0000 to 0.08675 O.D.). IMA levels correlated (Kendall’s tau: 0.239) significantly (P = 0.0146) with clinimetric evaluation with the use of Visual Analogue Scale (VAS). Multiple regression analysis of IMA levels and atherosclerosis risk factors showed significant correlation with triglycerides (r = 0.323, P = 0.0025) and homocysteine concentration (r = 0.225, P = 0.0224). Conclusions: Plasma ischemia-modified albumin is a useful marker of ischemia in migraine patients. IMA levels in migraineurs are influenced by concentrations of triglycerides and homocysteine.
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FP58-FR-03 Cutaneous application of menthol 10% solution as an abortive treatment of migraine without aura A. Borhani Haghighi, S. Motazedian, R. Rezaie, F. Mohammadi, L. Salarian, M. Pourmokhtari, S. Khodaei, Z. Shiravani, M. Vossoughi, R. Miri. Neurology, Shiraz University of Medical Sciences, Shiraz, Islamic Republic of Iran Purpose: To investigate the efficacy and safety of the cutaneous application of menthol 10% solution for the abortive treatment of migraine. Method: This is a Randomized, Triple-blind, Placebo-controlled, Crossed-over Study conducted in the neurology Clinic of Nemazee Hospital, affiliated with Shiraz University of Medical Sciences, Shiraz, southern Iran, from March 2007 to March 2008. The patients were recruited via local newspaper advertisements. Eligible patients were categorized into two groups and a 10% ethanol solution of menthol (as drug) and 0.5% ethanol solution of menthol (as placebo) were applied to the forehead and temporal area in a crossover design. Pain free, pain relief, sustained pain free and sustained pain relief end points were measured by questionnaires using a visual analog scale. Results: The intent-to-treat population consisted of 35 patients (80% female, 20% male, mean age: 29.6±6.2) with 118 migraine attacks. In the intent-to-treat population, the menthol solution was statistically superior to the placebo on two hour pain free (p = 0.001), two hour pain relief (p = 0.000), sustained pain free and sustained pain relief end points (p = 0.008). The menthol solution was also more efficacious in the alleviation of nausea and /or vomiting and phonophobia and /or photophobia (p = 0.02). In the per protocol population, there was significantly higher number of patients who experienced at least one pain free/pain relief after the application of menthol rather than the placebo (P = 0.002). No significant difference was seen between the adverse effects of the drug and the placebo groups (p= 0.13). Conclusion: Menthol solution can be an efficacious, safe and tolerable therapeutic option for the abortive treatment of migraine. FP58-FR-04 Clinical profile of the novel oral CGRP receptor antagonist telcagepant for the acute treatment of migraine in phase 3 studies T.W. Ho. Merck Research Laboratories, North Wales, United States Purpose: To assess the clinical profile of the oral CGRP receptor antagonist telcagepant in the acute treatment of migraine. Methods: Two randomized, double-blind, placebo-controlled clinical trials in adults treating a single moderate or severe migraine attack were performed. Study 1 treatments were telcagepant 150mg (N = 333), 300-mg (N = 354), zolmitriptan 5-mg (N = 345), or placebo (N = 348). Study 2 treatments were telcagepant 50-mg (N = 177), 150-mg (N = 381), 300-mg (N = 371), or placebo (N = 365). The 5 co-primary endpoints were pain-relief (mild or none), and freedom from pain, photophobia, phonophobia, and nausea, at 2h postdose. The key secondary endpoint was sustained pain-freedom from 2–24h postdose. Studies were analyzed separately and a pooled analysis was also performed. Results: In Study 1, telcagepant 300-mg was more effective than placebo for all co-primary, and the key secondary, endpoints (p ≤ 0.01). Significant differences were also seen for telcagepant 150-mg versus placebo (p ≤ 0.01) and zolmitriptan 5-mg versus placebo (p ≤ 0.001). The efficacy of telcagepant 300-mg was comparable to zolmitriptan 5-mg, telcagepant 150-mg was slightly less effective than zolmitriptan 5-mg. In Study 2, telcagepant 300mg was significantly more effective than placebo (p ≤ 0.001), as was telcagepant 150-mg (p ≤ 0.05). All doses of telcagepant and zolmitriptan were generally well-tolerated. In Study 1, overall adverse event rates for telcagepant 150-mg, 300-mg, zolmitriptan 5-mg, and placebo were 31.4%, 37.2%, 50.7% and 32.1%, respectively.
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19th World Congress of Neurology, Free Paper Abstracts / Journal of the Neurological Sciences 285 S1 (2009) S57–S154
In Study 2, overall adverse event rates for telcagepant 50-mg, 150mg, 300-mg, and placebo were 32.2%, 32.0%, 36.2% and 32.2%, respectively. Pooled data will be presented. Conclusions: The acute antimigraine efficacy of telcagepant 300mg and 150-mg was demonstrated in two phase 3 studies. The efficacy of telcagepant 300-mg was similar to zolmitriptan 5-mg. Telcagepant was generally well-tolerated, with overall adverse event rates comparable to placebo. FP58-FR-05 Efficacy and safety of botulinum toxin type A (Dysport® ) in the prophylaxis of migraine without aura S. Chankrachang1 , A. Arayawichanont2 , N. Poungvarin3 , S. Nidhinandana4 , P. Boonkongchuen5 , S. Towanabut6 , P. Sithinamsuwan4 , S. Kongsaengdao7 . 1 Chiang Mai University, Chiang Mai, Thailand; 2 Sappasithiprasong Hospital, Ubon Ratchatani, Thailand; 3 Siriraj Hospital, Bangkok, Thailand; 4 Pramongkutklao Hospital, Bangkok, Thailand; 5 Bhumipol Adulyadej Hospital, Bangkok, Thailand; 6 Prasat Neurological Institute, Bangkok, Thailand; 7 Rajavithi Hospital, Bangkok, Thailand Purpose: To investigate the efficacy and safety of botulinum toxin type A (BoNT-A, Dysport® ) in the prophylaxis of migraine without aura. Method: This double-blind, placebo-controlled trial randomized patients aged 18–65 years with 2–8 migraine attacks/month to receive a single dose of Dysport, 120U or 240U, or placebo, subcutaneously into both frontal and temporal facial regions, and two intramuscular injections into the occipital regions. Migraine frequency, duration and pain intensity over the previous 4 weeks were recorded in diaries at baseline and 4, 8 and 12 weeks after treatment, investigators and patients also provided global assessments of change from baseline. Results: 128 patients were randomized (placebo n = 42, Dysport120U n = 43, Dysport-240U n = 43) and 119 completed the study. Before treatment, the mean frequency of migraine attacks was about 5/month in each group. The mean (±SD) decrease in frequency from pre-treatment to weeks 8–12 was 2.2±2.6 with placebo, 2.0±2.4 with Dysport-120U and 1.8±3.2 with Dysport240U (difference not significant). Patients receiving Dysport-240U showed a significant improvement in total pain intensity score at weeks 0–4 (p = 0.03), vs placebo. Pain intensity was also lower in both Dysport groups than in the placebo group at weeks 8–12, although the differences were not statistically significant. The mean number of hours with moderate or severe headaches at weeks 0–4 was significantly lower with Dysport-240U than with placebo (p = 0.04). Investigator and patient global assessments showed significantly greater improvements with Dysport-240U than with placebo group between week 4 and week 12 (p < 0.05), therefore investigators and patients perceived treatment to be beneficial at this dose. Dysport was well tolerated. Conclusion: Dysport-240U shows promise for migraine prophylaxis by reducing total pain intensity score and pain duration, although not headache frequency. Further trials with better-defined outcome measures are warranted. FP58-FR-06 Efficacy of myofascial release therapy in a population with cervicogenic headache A.V. Nagrale. Physiotherapy, Career Institute Of Medical Sciences, Bhopal, India Purpose: There remains a considerable controversy and confusion on cervicogenic headache because of lack of biological markers and paucity of experimental models. Evidence denotes that the cervicogenic pain, in particular, myogenic referral of head pain can be due to the myofascial trigger points (MTrPs) of the cervical and upper back musculature. Lack of familiarity with the characteristic myofascial referred pain patterns frequently leads to misdiagnosis
and ineffectual headache interventions. Thus, the purpose of the study was to investigate the efficacy of Myofascial release therapy against the widely used Muscle energy technique (MET) in deactivation of sternocleidomastoid trigger point in a population with cervicogenic headache. Method: Sixty patients in an age group of 20–59 years having cervicogenic headache due to sternocleidomastoid trigger points palpated with pincer method were included in the study. Subjects within the control group were given Lewit’s Post Isometric Relaxation approach (7–10 sec) repeated 3–5 times per session. Experimental group was subjected to Myofascial Release Therapy including Gross release approach (1–2 min) followed by Focal release method (1–2 min) for sternocleidomastoid muscle repeated 10–15 times per session with 30 sec rest in between. Both the groups were followed for 3 times per week for 4 weeks. Headache Disability Index and Headache diary was used to assess the severity and frequency of headache. Data was analyzed using ANOVA and Cohen’s d test. Results: Myofascial release therapy caused a significant decline in the disability, severity and frequency of headache at P < 0.05. At the end of 4 weeks, experimental group was associated with rapid prognosis than control as displayed by cohen’s d test. Conclusion: Myofascial release therapy appeared to be a noninvasive, less expensive and effective conservative approach in deactivation of sternocleidomastoid trigger point in a population with cervicogenic headache.
FP59 – Myasthenia gravis FP59-FR-01 Factors associated with response to calcineurin inhibitors in myasthenia gravis Y. Nagane1 , S. Suzuki2 , N. Suzuki2 , K. Utsugisawa1 . 1 Department of Neurology, Hanamaki General Hospital, Hanamaki, Japan; 2 Department of Neurology, Keio University School of Medicine, Tokyo, Japan Purpose: To assess which clinical factors of patients with myasthenia gravis (MG) are associated with responsiveness to calcineurin inhibitors (CNIs) such as cyclosporine and tacrolimus. Method: We retrospectively analyzed the 6-month effects of CNIs in 62 MG patients excluding influences of other immune treatments, and determined factors associated with response to CNIs by logistic regression analysis. Clinical factors evaluated included age, sex, time since onset, age of onset, history of thymectomy, presence of thymoma, ocular- or generalized-type MG, quantitative MG score, dose of oral corticosteroid, choice of CNI, and positivities for serum autoantibody against acetylcholine receptor (AChR-Ab), a voltagegated potassium channel, Kv1.4 (Kv1.4-Ab), and titin (titin-Ab). Results: Frequency of patients who achieved neither ≥3-point reduction in quantitative MG score nor ≥25% reduction in daily dose of prednisolone (poor-responders) reached 35.5% (22/62), and 64.5% (40/62) of patients achieved at least one of these improvements (responders). Neither dose nor blood concentration of CNIs differed between groups. Multivariate logistic regression analysis revealed time since onset of disease (odds ratio = 0.85, p = 0.005) and presence of thymoma (odds ratio = 5.56, p = 0.05) as clinical factors predictive of response to CNIs. As for MG-related autoantibody status, Kv1.4-Ab positivity was associated with response (odds ratio = 9.01, p = 0.04) and showed a correlation to presence of thymoma (p < 0.01). Conclusions: In MG, the early stages of disease and thymomaassociated MG are responsive to treatment with CNIs.
well as demographic and socio-economic characteristics of the participants by a population based study. Method: This nationwide, home based prevalence study was done in 21 cities presenting all geographical regions of Turkey. Total 5323 households, aged between 18–65 years, were interviewed by using a structured interview form and examined for headache by specially trained 33 physicians. Interview form included diagnostic questions based on ICH-2 criteria for migraine, features of headache and associated symptoms, demographic and socioeconomic information, information about previous physician visits for headache, previous headache diagnoses, acute and prophylactic medication for headache, and access to headache medication. Results: Of 5323 participants (48.8% women and 51.2% men, mean age 35.9±12 years), 2376 reported having headaches during last one year and 871 were diagnosed as migraine. Migraine prevalence was estimated as 16.4% (8.5% in men and 24.6% in women). While 68.3% of migraineurs reported 3 or more migraine attacks in a month and 54.2% had usually severe headaches, only 4.9% were on propylactic treatment at present. Conclusions: The prevalence of migraine estimated as 16.4% in this study was similar to one of previous population based study done on 15–55 years old households which is 16.4%. However, in present study, women/men ratio (2.89) was higher than before. Lower rates of migraineurs on prophylactic treatment than expected was remarkable. FP58-FR-02 Plasma concentrations of ischemia-modified albumin in migraine patients S. Michalak1 , E. Wysocka2 , D. Wegrzyn3 , L. Torlinski2 , W. Kozubski3 . 1 Department of Neurochemistry and Neuropathology, Poznan University of Medical Sciences, Poznan, Poland; 2 Department of Clinical Biochemistry and Laboratory Medicine, Poznan University of Medical Sciences, Poznan, Poland; 3 Department of Neurology, Poznan University of Medical Sciences, Poznan, Poland Purpose: Ischemia-modified albumin (IMA) is a sensitive marker of myocardial ischemia and may be affected by ischemia occurring in other tissues. Migraine has been reported as a risk factor of ischemic stroke or cardiovascular events. Dysfunction of endothelial cells, as well as association with arteriopathies was evidenced in migraine patients. Cortical spreading depression-related oligemia, intracerebral large vessels spasm and endothelium-related hypercoagulability may cause ischemia in migraine patients. The aim of this study was to evaluate plasma levels of IMA in migraine patients during interictal period. Method: Fifty two migraineurs aged 37.9±9.6 yrs fulfilling IHS criteria for migraine were included in the study. The control group included 39 healthy volunteers aged 38.9±7.0 yrs. In all subjects neurological examination was carried on, as well as clinimetric evaluation with the use of: MIDAS, MIGSEV, QVM, VAS and VRS. Ischemia-modified albumin was evaluated by means of spectrophotometric method with the use of cobalt chloride. The IMA levels were expressed in optical density (O.D.) units. Results: Plasma concentrations of IMA were significantly (p = 0.0104) higher in migraine patients (median: 0.0841, interquartile range: 0.0000 to 0.3250 O.D.) than in controls (median: 0.0000, interquartile range: 0.0000 to 0.08675 O.D.). IMA levels correlated (Kendall’s tau: 0.239) significantly (P = 0.0146) with clinimetric evaluation with the use of Visual Analogue Scale (VAS). Multiple regression analysis of IMA levels and atherosclerosis risk factors showed significant correlation with triglycerides (r = 0.323, P = 0.0025) and homocysteine concentration (r = 0.225, P = 0.0224). Conclusions: Plasma ischemia-modified albumin is a useful marker of ischemia in migraine patients. IMA levels in migraineurs are influenced by concentrations of triglycerides and homocysteine.
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FP58-FR-03 Cutaneous application of menthol 10% solution as an abortive treatment of migraine without aura A. Borhani Haghighi, S. Motazedian, R. Rezaie, F. Mohammadi, L. Salarian, M. Pourmokhtari, S. Khodaei, Z. Shiravani, M. Vossoughi, R. Miri. Neurology, Shiraz University of Medical Sciences, Shiraz, Islamic Republic of Iran Purpose: To investigate the efficacy and safety of the cutaneous application of menthol 10% solution for the abortive treatment of migraine. Method: This is a Randomized, Triple-blind, Placebo-controlled, Crossed-over Study conducted in the neurology Clinic of Nemazee Hospital, affiliated with Shiraz University of Medical Sciences, Shiraz, southern Iran, from March 2007 to March 2008. The patients were recruited via local newspaper advertisements. Eligible patients were categorized into two groups and a 10% ethanol solution of menthol (as drug) and 0.5% ethanol solution of menthol (as placebo) were applied to the forehead and temporal area in a crossover design. Pain free, pain relief, sustained pain free and sustained pain relief end points were measured by questionnaires using a visual analog scale. Results: The intent-to-treat population consisted of 35 patients (80% female, 20% male, mean age: 29.6±6.2) with 118 migraine attacks. In the intent-to-treat population, the menthol solution was statistically superior to the placebo on two hour pain free (p = 0.001), two hour pain relief (p = 0.000), sustained pain free and sustained pain relief end points (p = 0.008). The menthol solution was also more efficacious in the alleviation of nausea and /or vomiting and phonophobia and /or photophobia (p = 0.02). In the per protocol population, there was significantly higher number of patients who experienced at least one pain free/pain relief after the application of menthol rather than the placebo (P = 0.002). No significant difference was seen between the adverse effects of the drug and the placebo groups (p= 0.13). Conclusion: Menthol solution can be an efficacious, safe and tolerable therapeutic option for the abortive treatment of migraine. FP58-FR-04 Clinical profile of the novel oral CGRP receptor antagonist telcagepant for the acute treatment of migraine in phase 3 studies T.W. Ho. Merck Research Laboratories, North Wales, United States Purpose: To assess the clinical profile of the oral CGRP receptor antagonist telcagepant in the acute treatment of migraine. Methods: Two randomized, double-blind, placebo-controlled clinical trials in adults treating a single moderate or severe migraine attack were performed. Study 1 treatments were telcagepant 150mg (N = 333), 300-mg (N = 354), zolmitriptan 5-mg (N = 345), or placebo (N = 348). Study 2 treatments were telcagepant 50-mg (N = 177), 150-mg (N = 381), 300-mg (N = 371), or placebo (N = 365). The 5 co-primary endpoints were pain-relief (mild or none), and freedom from pain, photophobia, phonophobia, and nausea, at 2h postdose. The key secondary endpoint was sustained pain-freedom from 2–24h postdose. Studies were analyzed separately and a pooled analysis was also performed. Results: In Study 1, telcagepant 300-mg was more effective than placebo for all co-primary, and the key secondary, endpoints (p ≤ 0.01). Significant differences were also seen for telcagepant 150-mg versus placebo (p ≤ 0.01) and zolmitriptan 5-mg versus placebo (p ≤ 0.001). The efficacy of telcagepant 300-mg was comparable to zolmitriptan 5-mg, telcagepant 150-mg was slightly less effective than zolmitriptan 5-mg. In Study 2, telcagepant 300mg was significantly more effective than placebo (p ≤ 0.001), as was telcagepant 150-mg (p ≤ 0.05). All doses of telcagepant and zolmitriptan were generally well-tolerated. In Study 1, overall adverse event rates for telcagepant 150-mg, 300-mg, zolmitriptan 5-mg, and placebo were 31.4%, 37.2%, 50.7% and 32.1%, respectively.
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19th World Congress of Neurology, Free Paper Abstracts / Journal of the Neurological Sciences 285 S1 (2009) S57–S154
In Study 2, overall adverse event rates for telcagepant 50-mg, 150mg, 300-mg, and placebo were 32.2%, 32.0%, 36.2% and 32.2%, respectively. Pooled data will be presented. Conclusions: The acute antimigraine efficacy of telcagepant 300mg and 150-mg was demonstrated in two phase 3 studies. The efficacy of telcagepant 300-mg was similar to zolmitriptan 5-mg. Telcagepant was generally well-tolerated, with overall adverse event rates comparable to placebo. FP58-FR-05 Efficacy and safety of botulinum toxin type A (Dysport® ) in the prophylaxis of migraine without aura S. Chankrachang1 , A. Arayawichanont2 , N. Poungvarin3 , S. Nidhinandana4 , P. Boonkongchuen5 , S. Towanabut6 , P. Sithinamsuwan4 , S. Kongsaengdao7 . 1 Chiang Mai University, Chiang Mai, Thailand; 2 Sappasithiprasong Hospital, Ubon Ratchatani, Thailand; 3 Siriraj Hospital, Bangkok, Thailand; 4 Pramongkutklao Hospital, Bangkok, Thailand; 5 Bhumipol Adulyadej Hospital, Bangkok, Thailand; 6 Prasat Neurological Institute, Bangkok, Thailand; 7 Rajavithi Hospital, Bangkok, Thailand Purpose: To investigate the efficacy and safety of botulinum toxin type A (BoNT-A, Dysport® ) in the prophylaxis of migraine without aura. Method: This double-blind, placebo-controlled trial randomized patients aged 18–65 years with 2–8 migraine attacks/month to receive a single dose of Dysport, 120U or 240U, or placebo, subcutaneously into both frontal and temporal facial regions, and two intramuscular injections into the occipital regions. Migraine frequency, duration and pain intensity over the previous 4 weeks were recorded in diaries at baseline and 4, 8 and 12 weeks after treatment, investigators and patients also provided global assessments of change from baseline. Results: 128 patients were randomized (placebo n = 42, Dysport120U n = 43, Dysport-240U n = 43) and 119 completed the study. Before treatment, the mean frequency of migraine attacks was about 5/month in each group. The mean (±SD) decrease in frequency from pre-treatment to weeks 8–12 was 2.2±2.6 with placebo, 2.0±2.4 with Dysport-120U and 1.8±3.2 with Dysport240U (difference not significant). Patients receiving Dysport-240U showed a significant improvement in total pain intensity score at weeks 0–4 (p = 0.03), vs placebo. Pain intensity was also lower in both Dysport groups than in the placebo group at weeks 8–12, although the differences were not statistically significant. The mean number of hours with moderate or severe headaches at weeks 0–4 was significantly lower with Dysport-240U than with placebo (p = 0.04). Investigator and patient global assessments showed significantly greater improvements with Dysport-240U than with placebo group between week 4 and week 12 (p < 0.05), therefore investigators and patients perceived treatment to be beneficial at this dose. Dysport was well tolerated. Conclusion: Dysport-240U shows promise for migraine prophylaxis by reducing total pain intensity score and pain duration, although not headache frequency. Further trials with better-defined outcome measures are warranted. FP58-FR-06 Efficacy of myofascial release therapy in a population with cervicogenic headache A.V. Nagrale. Physiotherapy, Career Institute Of Medical Sciences, Bhopal, India Purpose: There remains a considerable controversy and confusion on cervicogenic headache because of lack of biological markers and paucity of experimental models. Evidence denotes that the cervicogenic pain, in particular, myogenic referral of head pain can be due to the myofascial trigger points (MTrPs) of the cervical and upper back musculature. Lack of familiarity with the characteristic myofascial referred pain patterns frequently leads to misdiagnosis
and ineffectual headache interventions. Thus, the purpose of the study was to investigate the efficacy of Myofascial release therapy against the widely used Muscle energy technique (MET) in deactivation of sternocleidomastoid trigger point in a population with cervicogenic headache. Method: Sixty patients in an age group of 20–59 years having cervicogenic headache due to sternocleidomastoid trigger points palpated with pincer method were included in the study. Subjects within the control group were given Lewit’s Post Isometric Relaxation approach (7–10 sec) repeated 3–5 times per session. Experimental group was subjected to Myofascial Release Therapy including Gross release approach (1–2 min) followed by Focal release method (1–2 min) for sternocleidomastoid muscle repeated 10–15 times per session with 30 sec rest in between. Both the groups were followed for 3 times per week for 4 weeks. Headache Disability Index and Headache diary was used to assess the severity and frequency of headache. Data was analyzed using ANOVA and Cohen’s d test. Results: Myofascial release therapy caused a significant decline in the disability, severity and frequency of headache at P < 0.05. At the end of 4 weeks, experimental group was associated with rapid prognosis than control as displayed by cohen’s d test. Conclusion: Myofascial release therapy appeared to be a noninvasive, less expensive and effective conservative approach in deactivation of sternocleidomastoid trigger point in a population with cervicogenic headache.
FP59 – Myasthenia gravis FP59-FR-01 Factors associated with response to calcineurin inhibitors in myasthenia gravis Y. Nagane1 , S. Suzuki2 , N. Suzuki2 , K. Utsugisawa1 . 1 Department of Neurology, Hanamaki General Hospital, Hanamaki, Japan; 2 Department of Neurology, Keio University School of Medicine, Tokyo, Japan Purpose: To assess which clinical factors of patients with myasthenia gravis (MG) are associated with responsiveness to calcineurin inhibitors (CNIs) such as cyclosporine and tacrolimus. Method: We retrospectively analyzed the 6-month effects of CNIs in 62 MG patients excluding influences of other immune treatments, and determined factors associated with response to CNIs by logistic regression analysis. Clinical factors evaluated included age, sex, time since onset, age of onset, history of thymectomy, presence of thymoma, ocular- or generalized-type MG, quantitative MG score, dose of oral corticosteroid, choice of CNI, and positivities for serum autoantibody against acetylcholine receptor (AChR-Ab), a voltagegated potassium channel, Kv1.4 (Kv1.4-Ab), and titin (titin-Ab). Results: Frequency of patients who achieved neither ≥3-point reduction in quantitative MG score nor ≥25% reduction in daily dose of prednisolone (poor-responders) reached 35.5% (22/62), and 64.5% (40/62) of patients achieved at least one of these improvements (responders). Neither dose nor blood concentration of CNIs differed between groups. Multivariate logistic regression analysis revealed time since onset of disease (odds ratio = 0.85, p = 0.005) and presence of thymoma (odds ratio = 5.56, p = 0.05) as clinical factors predictive of response to CNIs. As for MG-related autoantibody status, Kv1.4-Ab positivity was associated with response (odds ratio = 9.01, p = 0.04) and showed a correlation to presence of thymoma (p < 0.01). Conclusions: In MG, the early stages of disease and thymomaassociated MG are responsive to treatment with CNIs.