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

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ClinicalTrials.gov Identifier: NCT02291380
Recruitment Status : Enrolling by invitation
First Posted : November 14, 2014
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Lanzhou Institute of Biological Products Co., Ltd

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.

Condition or disease Intervention/treatment Phase
Chronic Migraine Drug: Botulinum Toxin Type A for Injection Drug: Placebo Phase 3

Detailed 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.)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Placebo Parallel-Controlled Clinical Study to Evaluate the Safety and Efficacy of Botulinum Toxin Type A for Injection (HengLi ®) for Prophylactic Treatment of Chronic Migraine in Adults
Study Start Date : September 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Migraine

Arm Intervention/treatment
Active Comparator: Botulinum Toxin Type A for Injection
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
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.
Other Name: HengLi®

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




Primary Outcome Measures :
  1. Change from baseline in average number of days with headache per month [ Time Frame: Baseline (week -4 to 0) and core phase (week 21 to 24) ]
    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.


Secondary Outcome Measures :
  1. the average number of days with headache per month [ Time Frame: Baseline and Week 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52, 56 ]
    Change in the average number of days with headache per month versus the baseline

  2. the average frequency of headache per month [ Time Frame: Baseline and Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56 ]
    Change in the average frequency of headache per month versus the baseline

  3. the average frequency of migraine per month [ Time Frame: Baseline and Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56 ]
    Change in the average frequency of migraine per month versus the baseline

  4. Proportions of subjects [ Time Frame: Baseline and Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56 ]
    Proportions of subjects with a reduction in the average frequency of migraine per month≥50% and ≥30%

  5. Change in the average frequency of needing emergency analgesics per month [ Time Frame: Baseline and Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56 ]
    The number of days with the need of emergency analgesics during the observation period divided by the number of days in the observation period and multiplied by 28. The need of emergency analgesics refers to use of analgesics in case of attacks or use of drugs in advance to prevent pain attacks.

  6. Change in the average severity of migraine [ Time Frame: Baseline and Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56 ]
    Sum of severity scores of migraine episodes during the observation period divided by the number of migraine episodes. The severity of each migraine episode is the severity when the pain is the fiercest, expressed using VAS (0-10).

  7. Change in the average duration of migraine [ Time Frame: Baseline and Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56 ]
    Sum of durations of migraine episodes during the observation period divided by the number of migraine episodes.

  8. Migraine Disability Assessment Questionnaire score(MIDAS) [ Time Frame: Week 0,12,24,36,48,56 ]
    Change in the MIDAS per month versus the baseline

  9. Headache Impact Test (HIT) [ Time Frame: Week0,4,8,12,16,20,24,28,32,36,40,44,48,52,56 ]
    Change in the HIT per month versus the baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291380


Sponsors and Collaborators
Lanzhou Institute of Biological Products Co., Ltd
Investigators
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Study Director: Sheng yuan Yu The General Hospital of People's Liberation Army(301 hospital)

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Responsible Party: Lanzhou Institute of Biological Products Co., Ltd
ClinicalTrials.gov Identifier: NCT02291380     History of Changes
Other Study ID Numbers: HengLi003
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lanzhou Institute of Biological Products Co., Ltd:
Chronic Migraine
Botulinum Toxin Type A for Injection

Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents