Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат Erenumab 140 Mg/mL Subcutaneous Solution
  Active erenumab delivered via subcutaneous injection.
• Препарат Placebo
  Placebo delivered via subcutaneous injection.

Первичные конечные точки

• Monthly Headache Days [Срок оценки: Week 8 to Week 12]

Вторичные конечные точки (12)

• Monthly Headache Days [Срок оценки: Week 0 to Week 12]
• Monthly Headache Days [Срок оценки: Week 0 to Week 4]
• Monthly Headache Days [Срок оценки: Week 0 to Week 8]
• Adverse Events [Срок оценки: Week 0 to Week 12]
• Return to Full Duty [Срок оценки: Week 0 to Week 12]
• Concomitant Medications [Срок оценки: Week 0 to Week 12]
• Headache Days [Срок оценки: Week 0 to Week 12]
• HPFID Activity [Срок оценки: Week 0 to Week 12]
• HPFID Physical Impairment [Срок оценки: Week 0 to Week 12]
• HIT-6 [Срок оценки: Week 0 to Week 12]
• PHQ-9 [Срок оценки: Week 0 to Week 12]
• ISI [Срок оценки: Week 0 to Week 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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 3. post-traumatic amnesia for >1 day
• Participants with ongoing chronic migraine or other chronic daily headache disorders at the time of injury

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 4 центра

• Womack Army Medical Center - Fort Liberty — Fort Bragg
• University of Pittsburgh Concussion Research Laboratory — Pittsburgh
• William Beaumont Army Medical Center — El Paso
• Madigan Army Medical Center — Tacoma

Идентификаторы

NCT: NCT05049057 · CNRM-CGRP-2020

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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