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NCT03308968 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of Fremanezumab in Adults With Migraine
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 838
- Enrollment target
NCT03308968: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT03308968 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 838 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03308968, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 838 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of monthly and quarterly subcutaneous (sc) injections of fremanezumab compared with sc injections of placebo in participants with chronic migraine (CM) or episodic migraine (EM) who have responded inadequately to 2 to 4 classes of prior preventive treatments. Approximately equal numbers of participants from each subgroup (CM and EM) are randomized in blinded-fashion 1:1:1 into one of 3 treatments for the subgroup - 2 active treatments and 1 placebo treatment- consisting of monthly injections for 3 months (up to Week 12). Then all participants continue into an open-label extension of 3 months (up to Week 24) during which everyone is administered sc injections of fremanezumab.
Primary Outcome
A migraine day was defined as when at least 1 of the following situations occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache meeting criteria for migraine with or without aura; a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was tre
Interventions
- DRUG Placebo
- DRUG Fremanezumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 838 participants |
| Start Date | 2017-10-13 |
| Est. Completion | 2019-05-29 |
| Phase | Phase 3 |
What the finished NCT03308968 record still lists
NCT03308968 is an interventional study that assigns participants to a tested intervention. The registered 838 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03308968 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03308968 about?
NCT03308968 is a clinical study titled "An Efficacy and Safety Study of Fremanezumab in Adults With Migraine". The purpose of this study is to evaluate the efficacy, safety, and tolerability of monthly and quarterly subcutaneous (sc) injections of fremanezumab compared with sc injections of placebo in participants with chronic migraine (CM) or episodic migraine (EM) who have responded inadequately to 2 to 4 ...
What is the current status of trial NCT03308968?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 838 participants. The study started on 2017-10-13. Estimated completion is 2019-05-29.
What interventions are being tested in trial NCT03308968?
The interventions under investigation include: Placebo (DRUG), Fremanezumab (DRUG).
Who is sponsoring clinical trial NCT03308968?
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 NCT03308968's enrollment target sits among peer trials
838 394th of 2000 higher than 1,606 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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