drugset / Trial / NCT02291380
A Study to Evaluate Botulinum Toxin Type A for Injection(HengLi®)for Prophylactic Treatment of Chronic Migraine
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Botulinum toxin type A | Protein / enzyme biologic | 155 iu | Intramuscular |
| Comparator | Botulinum toxin type A | Protein / enzyme biologic | 195 iu | Intramuscular |