A phase III clinical trial for a novel herbal molecule (1% LLL-2011) developed by Lupin Li,ited which has a potential to prevent attacks of common migraine effectively.
- Registration Number
- CTRI/2009/091/000776
- Lead Sponsor
- upin Limited (Research Park), 46A/47A, Nande village, Mulshi taluka Pune ? 411042, Maharashtra, India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 214
1. 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)
2. Patients experience 2-6 migraine attacks* per month, but not more than 15
headache days# per month.
3. Male or female patients in the age group of 18 years to 60 years (inclusive).
4. Patients willing to sign Informed Consent Form.
Inclusion Criteria at Randomization Visit
1. Patients experience 2-6 migraine attacks* in placebo treatment
period, 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.
1. Patients have more than 15 headache days per month or less than 2 migraine
attacks per month.
2. Patients have more than 6 attacks per year of migraine with aura.
3. Pregnant women or nursing mothers.
4. 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.
5. Patients have commenced any form of migraine prophylactic therapy within 1
month prior to the enrollment.
6. Patients need antidepressant medicines.
7. 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.
8. Patients are diagnosed to have nasal pathologies that may interfere with the drug absorption.
9. 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.
10. 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.
11. History of acute myocardial infarction or stroke in 6 months preceding the signing of Informed Consent Form.
12. History of alcohol or drug dependence.
13. Unlikely to maintain a diary, comply with the medication or be regular in follow-up visits.
14. Any serious disease that would interfere with the compliance to the study protocol.
15. Patients previously participated in more than 2 migraine drug trials.
16. Patients who have received an Investigational Drug within 4 weeks prior to screening.
17. 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.
18. Patients with clinically significant renal, hepatic, cardiovascular, hemopoietic,
endocrinal, pulmonary, intestinal, psychiatric illness or severe mental retardation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of LLL-2011 (1%) and placebo in reducing the frequency of migraine headachesTimepoint: Baseline (visit 2) to end of treatment (visit 5)
- Secondary Outcome Measures
Name Time Method To determine the effect of LLL-2011 (1%) on reduction in the intensity and duration of migraine headachesTimepoint: Baseline (V2) to the end of treatment (V5);To determine the local tolerability profile of LLL-2011 (1%)Timepoint: Visit 1 to Visit 6;To study the responder rate of >50% in both active and placebo treatment groupsTimepoint: Baseline (visit 2) to end of treatment (visit 5)