Trials / Completed
CompletedNCT03347188
A Study to Test if Fremanezumab Reduces Headache in Participants With Posttraumatic Headache (PTH)
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 87 (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fremanezumab | Fremanezumab will be administered per dose and schedule specified in the arm. |
| DRUG | Placebo | Placebo matching to fremanezumab will be administered per schedule specified in the arm. |
Timeline
- Start date
- 2017-12-18
- Primary completion
- 2020-03-13
- Completion
- 2020-06-03
- First posted
- 2017-11-20
- Last updated
- 2022-12-13
- Results posted
- 2021-03-26
Locations
33 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03347188. Inclusion in this directory is not an endorsement.