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
试验速览
- 阶段
- 3 期
- 入组人数
- 288
- 主要终点
- Change from baseline in average number of days with headache per month
研究概览
简要总结
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.
详细描述
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.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Botulinum Toxin Type A for Injection (Drug)
Placebo
The placebo does not include botulinum toxin A ,but includes sucrose, dextran and gelatin.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in average number of days with headache per month
时间窗: 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.
次要结局
- 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)
- Headache Impact Test (HIT)(Week0,4,8,12,16,20,24,28,32,36,40,44,48,52,56)
- 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)
- 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)
- Change in the average severity of migraine(Baseline and Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56)
- the average frequency of headache per month(Baseline and Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56)
- Migraine Disability Assessment Questionnaire score(MIDAS)(Week 0,12,24,36,48,56)
- Change in the average duration of migraine(Baseline and Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56)