2024-515901-24-00招募中3 期
Safety and efficacy of botulinum toxin A in patients with posttraumatic headache: a double-blind, randomized, placebo-controlled, parallel-group trial and investigation of neuro-inflammatory biomarkers as predictors of efficacy.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The proportion of responders in BTX-A and placebo group during the evaluation period (weeks 5 to 8) compared with baseline (weeks -4 to -1). A subject who meets the following criterion will be classified as a responder: Has a reduction of ≥ 30% in number of days having moderate or severe headache
研究概览
简要总结
To investigate if botulinum toxin type A (BTX-A) is safe and more effective than placebo to lower the number of moderate-to-severe headache days in the evaluation period (weeks 5 to 8) compared to baseline (weeks -4 to -1)
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow up
- 盲法
- Double (Subject, Investigator, Carer, Monitor, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of persistent PTH according to criteria 5.2.2 Persistent headache attributed to mild traumatic injury to the head according to The International Classification of Headache Disorders 3rd edition.
- •Age between 18 and 80 years.
- •Subjects must have headache at least 15 days per month during the last 4 weeks to enter the baseline phase.
- •During baseline phase subjects must experience moderate-to-severe headache at least 8 days and headache at least 15 days to enter the treatment phase (to be randomized).
- •Fluency in Danish.
排除标准
- •More than two incidences of traumatic brain injuries.
- •Previous treatment with injections of BTX-A in the head or face.
- •Female subjects either pregnant, breastfeeding or with planned conception within the study period.
- •Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during the study. Acceptable methods of effective birth control include not having intercourse (true abstinence, when this is in line with the preferred and usual lifestyle of the subject), hormonal birth control methods (pills, shots/injections, implants, or patches), intrauterine devices, surgical contraceptive methods (vasectomy with medical assessment of the surgical success of this procedure or bilateral tubal ligation).
- •Known allergy to any component of BTX-A.
- •Infection at the proposed injection site.
- •Known severe neuromuscular disorders or any degree of disorder affecting the neuromuscular transmission.
- •Known comprised respiratory function.
- •Member of investigational site staff or relative of the investigator.
- •Severe cardiovascular and cerebrovascular disease such as ischemic heart disease, myocardial infarction or previous stroke or transient ischemic attack, major CVD interventions during the last three months.
- •Expected poor compliance, i.e., considered unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to the best of the subject’s and investigator’s knowledge.
- •Ongoing and unstable severe psychiatric disease.
- •Anamnestic or clinical symptoms of any kind that are deemed relevant for study participation by the physician who examines the patient.
- •A history of migraine or tension-type headache more than 5 days per month before the TBI.
- •Medication-overuse headache according to the according to The International Classification of Headache Disorders 3rd edition.
- •A history of moderate-to-severe TBI, whiplash injury, or craniotomy.
- •Change of preventive PTH treatment or treatment dose within two months prior to the baseline visit (see protocol Section 6.4 for a full list of these medications).
结局指标
主要结局
The proportion of responders in BTX-A and placebo group during the evaluation period (weeks 5 to 8) compared with baseline (weeks -4 to -1). A subject who meets the following criterion will be classified as a responder: Has a reduction of ≥ 30% in number of days having moderate or severe headache
The proportion of responders in BTX-A and placebo group during the evaluation period (weeks 5 to 8) compared with baseline (weeks -4 to -1). A subject who meets the following criterion will be classified as a responder: Has a reduction of ≥ 30% in number of days having moderate or severe headache
次要结局
- The degree of change in inflammatory biomarkers (See protocol Section 7.2.14 for the full list) in plasma and tears in responders versus non-responders in BTX-A and placebo group.
- The proportion of responders in BTX-A and placebo group during the evaluation period (weeks 9 to 12) compared with baseline (weeks -4 to -1). proportion of subjects reaching ≥50% reduction in number of days with moderate-to-severe headache during the evaluation period (weeks 5 to 8) compared with baseline (weeks -4 to -1).
- The proportion of subjects reaching ≥50% reduction in number of days with moderate-to-severe headache during the evaluation period (weeks 5 to 8) compared with baseline (weeks -4 to -1).
- The proportion of subjects reaching ≥75% reduction in number of days with moderate-to-severe headache during the evaluation period (weeks 5 to 8) compared with baseline (weeks -4 to -1).
- Proportion of subjects with a PGI-C scale response of “much improved” or “very much improved” at week 8 in BTX-A group and placebo group.
- Change from baseline to week 5 in the HIT-6, RPQ, HADS & ISI score in BTX-A and placebo group.
- Proportion of dropouts caused by increased intake of PTH medication or use of prohibited rescue medication in BTX-A group compared to the placebo group.
- Proportion of subjects with side effects registered in weeks 2 to 5 during treatment with BTX-A compared with placebo.
研究者
Department of Neurology, Danish Headache Center
Scientific
Rigshospitalet
研究点 (1)
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