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NCT03347188 · ClinicalTrials.gov registry record · Phase 2
A Study to Test if Fremanezumab Reduces Headache in Participants With Posttraumatic Headache (PTH)
A Phase 2 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 2
- Development phase
- 87
- Enrollment target
NCT03347188: Completed Phase 2 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT03347188 is a Phase 2 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 87 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03347188, a Phase 2 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 87 participants
- Enrollment target
Study 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).
Primary Outcome
A headache day was defined as a day when a participant reported a headache of at least moderate severity. Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) \* 28. The change was calculated as post-baseline value - baseline value. Least square (LS) mean was calculated using analysis of covariance (ANCOVA) model with
Interventions
- DRUG Placebo
- DRUG Fremanezumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2017-12-18 |
| Est. Completion | 2020-06-03 |
| Phase | Phase 2 |
What the finished NCT03347188 record still lists
NCT03347188 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03347188 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03347188 about?
NCT03347188 is a clinical study titled "A Study to Test if Fremanezumab Reduces Headache in Participants With Posttraumatic Headache (PTH)". 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...
What is the current status of trial NCT03347188?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 87 participants. The study started on 2017-12-18. Estimated completion is 2020-06-03.
What interventions are being tested in trial NCT03347188?
The interventions under investigation include: Placebo (DRUG), Fremanezumab (DRUG).
Who is sponsoring clinical trial NCT03347188?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03347188's enrollment target sits among peer trials
87 810th of 2000 higher than 1,189 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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