BACT - Botulinum Toxin A in Frequent and Chronic Tension-type Headache With the FollowTheSutures Paradigm. A Double Blind, Randomized, Placebo-controlled Cross-over Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Difference in TTH-headache days in week 5-8 of the active period versus the placebo period.
研究概览
简要总结
Chronic tension-type headache (CTTH) is an underestimated disabling condition that affects a large number of patients. The treatment options for both episodic tension-type headaches, but especially CTTH are few. Poor long-term effects of existing treatment for CTTH (Sarotex, SSRIs, physiotherapy) are reported. Patients with CTTH also have a high risk of developing drug overdose headache (MOH). Non-drug treatments with physiotherapy or alternative medicine also show poor long-term effects. Literature reviews show that there is surprisingly little research on CTTH. Some small clinical trials report a good effect of treatment with botulinum toxin A, but larger controlled trials are needed to confirm or deny this.
The investigators will study effect of treatment with botulinum toxin A in CTTH in BACT study, and will include participants with both frequent and chronic TTH with 10 or more headache days per month.
If BACT outcomes are positive, this will open a possibility for a new treatment for TTH patients.
详细描述
BACT studies the efficacy of treatment with botulinum toxin with a follwthestuture injection regime in frequent and chronic tension type headache (TTH). This is be a randomized, placebo-controlled, triple blind, cross-over trial. The primary efficacy variable is the difference in monthly headache days in the active period versus the placebo period. In this study, injections will follow a slightly modified FollowTheSutures injection protocol. Study duration is 36 weeks long. The target population is male and female patients 18 to 75 years of age with TTH, with 10 or more headache days per month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Botulinum toxin A injections
Botulinum toxin A (Botox)
干预措施: Botulinum Toxin Type A in saline water (Drug)
Botulinum toxin A injections
Botulinum toxin A (Botox)
干预措施: Isotone saline water (Drug)
placebo injections
Isotone saline water
干预措施: Botulinum Toxin Type A in saline water (Drug)
placebo injections
Isotone saline water
干预措施: Isotone saline water (Drug)
结局指标
主要结局
Difference in TTH-headache days in week 5-8 of the active period versus the placebo period.
时间窗: 36 weeks
Difference in TTH- headache days in week 5-8 of the active period versus the placebo period.
次要结局
- 30% responders (30% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12(36 weeks)
- Headache Impact Test (HIT-6)(36 weeks)
- Average number of headache hours per day in week 1-4, 5-8 and 9-12.(36 weeks)
- Acceptability(36 weeks)
- 50% responders (50% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12(36 weeks)
- Quality of life score on EQ-5D-5L(36 weeks)
- Average maximum pain intensity in Numeric Rating Scale (NRS from 0 to10) in week 1-4, 5-8 and 9-12(36 weeks)
- Average number of days with intake of painkillers per month in week 1-4, 5-8 and 9-12(36 weeks)
- Difference in TTH-headache days in week 1-4 and 9-12, and in the entire treatment period(36 weeks)
- Patient Global Impression of Improvement (PGI-I)(36 weeks)
- Difference in occurrence of adverse events and serious adverse events in the active period and the placebo period(36 weeks)