Status:
UNKNOWN
A Study to Evaluate Botulinum Toxin Type A for Injection（HengLi®）for Prophylactic Treatment of Chronic Migraine
Lead Sponsor:
Lanzhou Institute of Biological Products Co., Ltd
Conditions:
Chronic Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
A study, multi-center, randomized, double-blind, placebo parallel-controlled method, will be carried out to evaluate the safety and efficacy of Botulinum Toxin Type A for injection (HengLi®) for proph...
Detailed Description
Subjects in the core phase will be randomized into two groups: Botulinum Toxin Type A (HengLi®) (155U to 195U) or placebo. Study include a 28-day baseline screening period, a 24-week core phase with 2...
Eligibility Criteria
Inclusion
- Age≥18 and ≤65, male or female;
- Subjects voluntarily sign the informed consent.
- Patients complying with the ICHD-3(β) diagnostic criteria for chronic migraine.
Exclusion
- Females who are pregnant, nursing, or planning a pregnancy during the study period, or females of childbearing potential, not using a reliable means of contraception;
- Known allergy or sensitivity to study medication or its component;
- Subjects having accepted prophylactic treatments of migraine (e.g. propranolol, metoprolol, bisoprolol, flunarizine, valproate, topiramate, gabapentin, naproxen, aspirin, amitriptyline, candesartan, lisinopril, etc.) within the 4 weeks before screening;
- Subjects with cardiac functional insufficiency;
- Subjects with renal insufficiency (serum creatinine\>1.5 times ULN);
- Subjects with hepatic diseases (ALT or AST\>twice ULN);
- Subjects with systemic myoneural junction diseases (e.g. myasthenia, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.);
- Subjects with a history of facial palsy;
- Infection or dermatological condition at the injection sites;
- Patients with other types of migraine that do not comply with the diagnostic criteria for chronic migraine;
- Subjects ever took any type of botulinum toxin therapy in the past 6 months;
- Subjects who have used aminoglycoside antibiotics in the recent week or need to use aminoglycoside antibiotics during conduct of the clinical study;
- Subjects live with severe cognitive disorder or mental illness, outcomes will not be measured objectively;
- Subjects live with alcohol or drug abuse;
- Subjects who have been involved in other clinical studies over the 3 months prior to this study;
- Investigator's opinion that the subject has a concurrent condition(s) that may put the subject at significant risk, may confound the study results, or may interfere significantly with the conduct of the study.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT02291380
Start Date
September 1 2014
End Date
June 1 2020
Last Update
January 3 2018
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