A phase III, multi-center, placebo-controlled, double blind, randomized, parallel group study to establish the efficacy of LLL-2011 administered as a 1% nasal spray in the preventive treatment of common migraine.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 214
- 试验地点
- 13
- 主要终点
- To assess the effect of LLL-2011 (1%) and placebo in reducing the frequency of migraine headaches
研究概览
简要总结
This will be a multi-center, randomized, parallel group, placebo controlled, double blind study to establish the efficacy and tolerability of LLL-2011 (1%) administered as a nasal spray (accentuation) in each nostril twice daily for 3 months in the preventive treatment of common migraine. Adequate number of patients will be enrolled so as to give minimum 214 evaluable patients (107 patients in each treatment group).The total duration of the study will be approximately 5 months. The study begins with a screening evaluation.Patients fulfilling all the inclusion and exclusion criteria will be given placebo nasal spray to be administered in each nostril two times a day for 1 month. This initial 1 month, single blind placebo treatment period will establish the baseline migraine frequency attack rate.After 1 month period patients with common migraine conforming to IHS guidelines will be randomly assigned to one of the two treatment groups in a ratio of 1:1, LLL-2011 (1%) nasal spray or Placebo nasal spray, to be administered twice daily for 3 months.This period will be followed by 1 month of treatment free-follow-up period.During the entire duration of study period, patients will be allowed to use the rescue medication. However, it will require recording the use of rescue medication in the diary.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
入选标准
- •Patients with history of migraine without aura for at least 6 months prior to screening visit for study.
- •[As per ICHD-2.1.1] (Appendix F)
- •Patients experience 2-6 migraine attacks* per month, but not more than 15headache days# per month.
- •Male or female patients in the age group of 18 years to 60 years (inclusive).
- •Patients willing to sign Informed Consent Form.Inclusion Criteria at Randomization Visit
- •Patients experience 2-6 migraine attacks* in placebo treatmentperiod, but not more than 15 headache days# per month.* Each migraine attack should conform to criteria of International Classification of Headache Disorders, (2.1.1).# Headache days: Number of days in a month patient experiences headache.
排除标准
- •Patients have more than 15 headache days per month or less than 2 migraine attacks per month.
- •Patients have more than 6 attacks per year of migraine with aura.
- •Pregnant women or nursing mothers.
- •Women of child-bearing potential & all men not willing to follow a reliable & effective contraceptive measure during the course of the study & at least 3 months after the last visit.
- •Patients have commenced any form of migraine prophylactic therapy within 1 month prior to the enrollment.
- •Patients need antidepressant medicines.
- •Patients 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 a psychiatric illness.
- •Patients with uncontrolled diabetes, uncontrolled hypertension, epilepsy or other co-existing disease for which they require a concomitant medication with anti-migraine activity, such as: β blockers, calcium channel blockers, antidepressants or antiepileptics.
- •Patients with history of overuse or require rescue* medication for acute migraine treatment for more than 10 treatment days per month or more than 3 days per week.
- •*Ergots or Triptans, Antiemetics, NSAIDS & Non opiate analgesics, Opiate analgesics, Barbiturate Hypnotics, Corticosteroids, local anesthetics, Botulinum toxin or anti-migraine herbal preparations.
- •History of acute myocardial infarction or stroke in 6 months preceding the signing of Informed Consent Form.
- •History of alcohol or drug dependence.
- •Unlikely to maintain a diary, comply with the medication or be regular in follow-up visits.
- •Any serious disease that would interfere with the compliance to the study protocol.
- •Patients previously participated in more than 2 migraine drug trials.
- •Patients who have received an Investigational Drug within 4 weeks prior to screening.
- •Serum SGOT and SGPT > 3 X, Alkaline Phosphatase > 1.5 X, Creatinine >1.5 X and Total bilirubin > 1.5 X the upper limits of the normal (ULN) of the reference range at the screening assessment.
- •Patients with clinically significant renal, hepatic, cardiovascular, hemopoietic, endocrinal, pulmonary, intestinal, psychiatric illness or severe mental retardation.
结局指标
主要结局
To assess the effect of LLL-2011 (1%) and placebo in reducing the frequency of migraine headaches
时间窗: Baseline (visit 2) to end of treatment (visit 5)
次要结局
- To determine the effect of LLL-2011 (1%) on reduction in the intensity and duration of migraine headaches(Baseline (V2) to the end of treatment (V5))
- To study the responder rate of >50% in both active and placebo treatment groups(Baseline (visit 2) to end of treatment (visit 5))
- To determine the local tolerability profile of LLL-2011 (1%)(Visit 1 to Visit 6)