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

Part of paid clinical trials in Fort Bragg, North Carolina.

Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Study ID
NCT05049057
Phase
PHASE2
Status
Recruiting
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Conditions

  • Mild Traumatic Brain Injury
  • Posttraumatic Headache

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Jul 19, 2022
Status verified
Feb 2024
Primary completion
May 19, 2026
Completion
May 19, 2027

Study Design

Enrollment
404 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Drug
    Erenumab administered once monthly via two 70-mg subcutaneous injections at 3 time points over a 12-week period.
  • Placebo Comparator: Placebo
    Placebo administered once monthly via two subcutaneous injections at 3 time points over a 12-week period.

Primary Outcome Measure

Monthly Headache Days [ Time Frame: Week 8 to Week 12 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Womack Army Medical Center - Fort LibertyFort BraggNorth Carolina28310
Jennifer Robles, RN
[email protected]
240-749-1042
Alexandra Fraiser
[email protected]
240-749-4550
CDR Katherine Demers (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Concussion Research LaboratoryPittsburghPennsylvania15203
Courtney Perry
[email protected]
412-904-1298
Anthony Kontos, MD (PRINCIPAL_INVESTIGATOR)
William Beaumont Army Medical CenterEl PasoTexas79918
Cecilia Valdovinos, NP
[email protected]
Sean Sebesta, MD (PRINCIPAL_INVESTIGATOR)
Madigan Army Medical CenterTacomaWashington98431
Janel Cuevas
[email protected]
240-890-6518
Melissa Belle, NP (PRINCIPAL_INVESTIGATOR)

Find similar trials in Fort Bragg, NC

By research site
Womack Army Medical Center - Fort Liberty· Fort Bragg, NCUniversity of Pittsburgh Concussion Research Laboratory· Pittsburgh, PAWilliam Beaumont Army Medical Center· El Paso, TXMadigan Army Medical Center· Tacoma, WA

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