Treatment of Acute Post-Traumatic Headache With Erenumab 140 mg, Military Service Members and Civilians With Mild TBI: A Randomized, Double Blind, Placebo Controlled, Multicenter 12-week Duration Study Followed by a 4-week Open-Label Safety Extension
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 404
- 试验地点
- 4
- 主要终点
- Monthly Headache Days
研究概览
简要总结
This study aims to assess the effect and safety of erenumab compared to placebo for the treatment of acute posttraumatic headache (PTH) in military service members and civilians with mild traumatic brain injury (mTBI).
详细描述
Headache is recognized as one of the most common and disabling symptoms following head trauma. This study is designed to assess a calcitonin gene-related peptide (cGRP) monoclonal antibody (erenumab) for the preventive treatment of PTH based on the rationale that headache posttrauma is similar to migraine and is mediated by the activation of the trigeminal vascular system and subsequent release of cGRP. This study is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of erenumab 140 mg for the treatment of PTH in military service members and civilians with mTBI at military treatment facilities across the United States.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 and ≤50 years of age
- •mTBI from any cause including impact, rotational acceleration, blast, or a combination, has occurred within the prior 7 days
- •PTH has occurred within the prior 7 days
- •Able to provide informed consent
- •Likely to stay in the same geographical area for the duration of study
- •Has a personal health care provider for standard of care PTH and TBI, including education, diagnostic procedures including neuroimaging and treatment, as deemed clinically indicated by the health care provider
排除标准
- •Sustained a moderate or severe TBI, rather than mTBI, indicated with at least 1 of the following associated with head injury:
- •abnormal structural imaging
- •loss of consciousness for >30 minutes
- •alteration of consciousness/mental state for >24 hours
- •post-traumatic amnesia for >1 day
- •Participants with ongoing chronic migraine or other chronic daily headache disorders at the time of injury
研究组 & 干预措施
Active Drug
Erenumab administered once monthly via two 70-mg subcutaneous injections at 3 time points over a 12-week period.
干预措施: Erenumab 140 Mg/mL Subcutaneous Solution (Drug)
Placebo
Placebo administered once monthly via two subcutaneous injections at 3 time points over a 12-week period.
干预措施: Placebo (Drug)
结局指标
主要结局
Monthly Headache Days
时间窗: Week 8 to Week 12
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
次要结局
- Monthly Headache Days(Week 0 to Week 8)
- Adverse Events(Week 0 to Week 12)
- HPFID Activity(Week 0 to Week 12)
- HPFID Physical Impairment(Week 0 to Week 12)
- PHQ-9(Week 0 to Week 12)
- Concomitant Medications(Week 0 to Week 12)
- Return to Full Duty(Week 0 to Week 12)
- Headache Days(Week 0 to Week 12)
- HIT-6(Week 0 to Week 12)
- ISI(Week 0 to Week 12)