A post marketing, open label, multicentre study to evaluate the safety and efficacy of Fixed Dose Combination of Propranolol Hydrochloride 40 mg plus Flunarizine 5 mg and Fixed Dose Combination of Propranolol Hydrochloride 40 mg plus Flunarizine 10 mg in the prophylaxis of migraine without aura.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- 1.Frequency of migraine attacks.
研究概览
简要总结
Objective
PrimaryObjective
To evaluate the safety of Fixed Dose Combination(FDC) of propranolol hydrochloride 40 mg plusflunarizine 5 mg and fdc of propranololhydrochloride 40 mg plus flunarizine 10 mg in the prophylaxis ofmigraine without aura.
SecondaryObjective
Toevaluate the efficacy of FDC of propranololhydrochloride 40 mg plus flunarizine 5 mg and fdc of propranolol hydrochloride 40 mg plus flunarizine 10mg in the prophylaxis of migraine without aura.
REFERENCES
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8. ShieldsKG, Goadsby PJ, Propranolol modulates trigeminovascular responses in thalamicventroposteromedial nucleus: a role in migraine, Brain Vol. 128 No. 1 #Guarantors of Brain 2004 doi:10.1093/brain/awh298.
9. Hayes Aand Cooper RG, Studies on the absorption, distribution and excretion ofpropranolol in rat, dog and monkey, Journal of Pharmacology and ExperimentalTherapeutics February 1971, 176 (2) 302-311.
10. Shinde V,Yegnanarayan R et.al, Antidepressant-Like Activity of Flunarizine in ModifiedTail Suspension Test in Rats, North American journal of medical sciences, doi:10.4103/1947- 2714.15392.
11. RaybarmanC, The efficacy of combined low-doses of propranolol and flunarizine inepisodic migraine, Eastern Journal of Medicine, Volume:21, Number:2,April-June/2016.
12. Bhat MF,Sidhu HS et.al, Evaluation of propranolol, flunarizine and divalproex sodium inprophylaxis of migraine, International Journal of Basic & ClinicalPharmacology, DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20174377, October2017, Vol 6, Issue 10.
13. Highlightsof prescribing information of innopran xl (propranolol hydrochloride)
14. Productmonograph of flunarizine.
15. Inderal®(propranolol hydrochloride) Tablets.
16. K. Lindeand K. Rossnagel, “Propranolol for migraine prophylaxis,†Cochrane Database ofSystematic Reviews, vol. 2, Article ID CD003225, 2004
17. D. K.Ziegler, A. Hurwitz, R. S. Hassanein, H. A. Kodanaz, S. H. Preskorn, and J.Mason, “Migraine prophylaxis. A comparison of propranolol and amitriptyline,â€Archives of Neurology, vol. 44, no. 5, pp. 486–489, 1987.
18. A.Pradalier, G. Serratrice, M. Collard et al., “Long-acting propranolol inmigraine prophylaxis: results of a double-blind, placebo-controlled study,â€Cephalalgia, vol. 9, no. 4, pp. 247–253, 1989
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21. H. C.Diener, J. Matias-Guiu, E. Hartung et al., “Efficacy and tolerability inmigraine prophylaxis of flunarizine in reduced doses: a comparison withpropranolol 160 mg daily,†Cephalalgia, vol. 22, no. 3, pp. 209–221, 2002.
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研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either sex, between the ages of 18 to 65 years.
- •2.Patients with history of migraine without aura for at least 3 months prior to evaluation of study as per International Classification of Headache Disorders (ICHD) 3.Patients experience 2-6 migraine attacks per month, but not more than 15 headache days per month.
- •4.Patients willing to sign Informed Consent Form.
排除标准
- •1.Patients have more than 15 headache days per month or less than 2 migraine attacks per month.
- •2.Pregnant women or nursing mothers.
- •3.Women of child-bearing potential & all men not willing to follow a reliable & effective birth control measure during the course of the study & at least 3 months after the last visit.
- •4.Patients have commenced any form of migraine prophylactic therapy within 1 month preceding the trial.
- •5.Patients need antidepressant medicines.
- •6.Patient’s headache attacks are associated with or attributable to an identifiable cause, such as: premenstrual period; a disease of eye, ear or nose; a neurological disease or psychosis.
- •7.Patients with known history of bronchial asthma.
- •8.Patients with known history of dyslipidemia.
- •9.Patients with diabetes mellitus, uncontrolled hypertension, epilepsy or other co-existing disease for which they require a concomitant medication with anti-migraine activity, such as: beta-blocker, calcium channel blockers, antidepressants or antiepileptics.
- •10.Unlikely to maintain a headache diary, comply with the medication or be regular in follow-up visits.
- •11.Any serious disease that would interfere with the compliance to the study protocol.
结局指标
主要结局
1.Frequency of migraine attacks.
时间窗: Day 01; Day 30±2; Day 60±2; Day 90±2
2.Intensity of migraine attacks.
时间窗: Day 01; Day 30±2; Day 60±2; Day 90±2
3.Migraine disability assessed by Migraine Disability Assessment (MIDAS) scale.
时间窗: Day 01; Day 30±2; Day 60±2; Day 90±2
次要结局
- 1.Change in percentage of patients with MIDAS grade from baseline to end of the study.(2.Responder rate of more than 50% reduction in total MIDAS score.)