A Study to Evaluate Botulinum Toxin Type A for Injection（HengLi®）for Prophylactic Treatment of Chronic Migraine

• Status: Unknown status
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

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 prophylactic treatment with chronic migraine in adults. In the core phase, two treatments of HengLi® or the placebo will be administrated (randomized at a ratio of 2:1, the target number is 288 subjects). In the extension phase, three treatments of HengLi® will be still administrated on 288 subjects recruited ever.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lanzhou Institute of Biological Products Co., Ltd
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.