drugset / Trial / NCT02291380

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

NCT02291380

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2014-09
Primary completion
2019-12
Completion
2020-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Botulinum toxin type A Protein / enzyme biologic 155 iu Intramuscular
Comparator Botulinum toxin type A Protein / enzyme biologic 195 iu Intramuscular

Indications