CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 87 enrolled
Drug / intervention
Fremanezumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03347188
NCT03347188Phase 2Completed
CompareCT.gov

A Phase 2, Multicenter, Randomized, Proof-of-Concept, Double-Blind, Placebo-Controlled, Parallel-Group Study, Including an Open-Label Period, Evaluating the Efficacy and Safety of 1 Subcutaneous Dose Regimen of Fremanezumab for the Treatment of Posttraumatic Headache (PTH)

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Nov 20, 2017·Updated Dec 13, 2022

In Brief

A Phase 2 clinical trial evaluating Fremanezumab and Placebo for Post-Traumatic Headache. Completed, enrolled 87 participants across 33 sites.

Detailed Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of fremanezumab in adult participants aged 18 to 70 years, inclusive, for the prevention of PTH. The study will include a double-blind (DB) treatment period (12 weeks) and an open-label (OL) treatment period (12 weeks).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-Traumatic Headache
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 20, 2017
Enrollment StartDec 18, 2017
Primary CompletionMar 13, 2020
Study CompletionJun 3, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.6 years ago

Interventions

Fremanezumabdrug

Fremanezumab will be administered per dose and schedule specified in the arm.

Placebodrug

Placebo matching to fremanezumab will be administered per schedule specified in the arm.