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

NCT02291380 | Unknown Phase 3 DMC

• 1 other identifier: HengLi003
• Study Type: interventional
• Target: 288
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Chronic Migraine

Keywords

Chronic Migraine; Botulinum Toxin Type A for Injection

Outcome Measures

Primary Outcomes (1)

• Change from baseline in 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.

  Baseline (week -4 to 0) and core phase (week 21 to 24)

Secondary Outcomes (9)

• the average number of days with headache per month

  Baseline and Week 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52, 56

• the average frequency of headache per month

  Baseline and Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56

• the average frequency of migraine per month

  Baseline and Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56

• Proportions of subjects

  Baseline and Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56

• Change in the average frequency of needing emergency analgesics per month

  Baseline and Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56

Study Arms (2)

Botulinum Toxin Type A for Injection

ACTIVE COMPARATOR

Botulinum Toxin Type A is a specific formulation of a locally injected muscle relaxant whose active ingredient is botulinum toxin type A produced by clostridium botulinum A strain Hall. Excipients contain sucrose, dextran and gelatin.

Drug: Botulinum Toxin Type A for Injection

Placebo

PLACEBO COMPARATOR

The placebo does not include botulinum toxin A ,but includes sucrose, dextran and gelatin.

Drug: Placebo

Interventions

Botulinum Toxin Type A for Injection DRUG

In these studies ,patients received a minimum intramuscular (IM) dose of 155 U of Botulinum Toxin Type A（HengLi®）administered to 31 injection sites across 7 head and neck muscles using a fixed-site, fixed-dose injection paradigm (each injection was 5 U in 0.1 mL). In addition, up to 40 U Botulinum Toxin Type A,administered IM to 8 additional injection sites across 3 head and neck muscles, was allowed, using a follow-the-pain approach. Thus, the minimum dose was 155 U and the maximum dose was 195 U. In the core phase, two doses of HengLi® will be injected.In the extension phase, three doses of HengLi® will be injected.

Also known as: HengLi®

Botulinum Toxin Type A for Injection

Placebo DRUG

In these studies, patients received placebo administered to 31 injection sites across 7 head and neck muscles using a fixed-site, fixed-dose injection paradigm (each injection was 0.1 mL). In addition, up to 0.8 mL placebo, administered IM to 8 additional injection sites across 3 head and neck muscles, was allowed, using a follow-the-pain approach. In the core phase, two doses of placebo will be injected.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Lanzhou Institute of Biological Products Co., Ltd: lead

MeSH Terms

Interventions

Botulinum Toxins, Type A; Injections; Hengli BTX-A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Sheng yuan Yu

  The General Hospital of People's Liberation Army(301 hospital)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 14, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: January 3, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share