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

Last updated: January 1, 2018
Sponsor: Lanzhou Institute of Biological Products Co., Ltd
Overall Status: Active - Enrolling

Phase

3

Condition

Migraine (Pediatric)

Migraine And Cluster Headaches

Oral Facial Pain

Treatment

N/A

Clinical Study ID

NCT02291380
HengLi003
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Females who are pregnant, nursing, or planning a pregnancy during the study period, orfemales 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 beforescreening;

  • 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-Lambertsyndrome, 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 criteriafor 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 useaminoglycoside antibiotics during conduct of the clinical study;

  • Subjects live with severe cognitive disorder or mental illness, outcomes will not bemeasured objectively;

  • Subjects live with alcohol or drug abuse;

  • Subjects who have been involved in other clinical studies over the 3 months prior tothis study;

  • Investigator's opinion that the subject has a concurrent condition(s) that may put thesubject at significant risk, may confound the study results, or may interferesignificantly with the conduct of the study.

Study Design

Total Participants: 288
Study Start date:
September 01, 2014
Estimated Completion Date:
June 30, 2020

Study 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 administrations, and a 32-week extension phase with 3 administrations .Subjects enrolled will get a e-headache-diary in recording their headache symptoms and acute headache medications.

HengLi® was administered as 31 fixed-site, fixed-dose (5U), i.m. injections across 7 specific head/neck muscle areas every 12 weeks (weeks 0, 12, 24, 36, and 48). At the investigator's discretion, up to 40 U of additional HengLi® could have been administered among 3 muscle groups (occipitalis, temporalis, or trapezius) using a protocol-defined paradigm. Hence the maximum dose per treatment cycle was 195 U over 39 sites.

Efficacy Outcome Measures should be evaluated by headache diary, HIT-6 score and MIDAS score . The primary Outcome Measure: Change from baseline in the average number of days with headache per month (The last 4 weeks during the core phase and the 4 weeks during the baseline period should be compared with the number of headache days per month on average.)