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NCT02945046 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH)
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Terminated
- Registry status
- Phase 3
- Development phase
- 169
- Enrollment target
NCT02945046: Clinical Trial Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT02945046 is a Phase 3 study that was terminated before completion, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 169 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02945046, a Phase 3 study, was terminated before completion, sponsored by Teva Branded Pharmaceutical Products R&D.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 169 participants
- Enrollment target
Study Summary
This is a 13-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group study to compare the efficacy and safety of 2 dose regimens of TEV-48125 (Fremanezumab) versus placebo in adult participants for the prevention of ECH.
Primary Outcome
A CH attack was defined as a severe or very severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes with either or both of the following 2 categories: 1) at least 1 of the following symptoms or signs, ipsilateral to the headache: -conjunctival injection and/or lacrimation; -nasal congestion and/or rhinorrhea; -eyelid edema; -forehead and facial sweating; -forehead and facial flushing; -sensation of fullness in the ear; -miosis and/or ptosis. 2) a sense of restless
Interventions
- DRUG Placebo
- DRUG Fremanezumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2017-01-19 |
| Est. Completion | 2019-05-13 |
| Phase | Phase 3 |
Why NCT02945046 stopped before completion
NCT02945046 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02945046 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02945046 about?
NCT02945046 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH)". This is a 13-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group study to compare the efficacy and safety of 2 dose regimens of TEV-48125 (Fremanezumab) versus placebo in adult participants for the prevention of ECH.
What is the current status of trial NCT02945046?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 169 participants. The study started on 2017-01-19. Estimated completion is 2019-05-13.
What interventions are being tested in trial NCT02945046?
The interventions under investigation include: Placebo (DRUG), Fremanezumab (DRUG).
Who is sponsoring clinical trial NCT02945046?
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 NCT02945046's enrollment target sits among peer trials
169 1459th of 2000 higher than 542 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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