Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03107052 · ClinicalTrials.gov registry record · Phase 3
A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab (TEV-48125) for the Prevention of Cluster Headache
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Terminated
- Registry status
- Phase 3
- Development phase
- 275
- Enrollment target
NCT03107052 is a Phase 3 study that was terminated before completion, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 275 participants.
The verdict
NCT03107052, a Phase 3 study, was terminated before completion, sponsored by Teva Branded Pharmaceutical Products R&D.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 275 participants
- Enrollment target
Study Summary
This is a 68-week study to evaluate the long-term safety and efficacy of fremanezumab in participants with cluster headache (CH). Participants who complete the pivotal studies TV48125-CNS-30056 (NCT02945046) and TV48125-CNS-30057 (NCT02964338) and enroll into the current study will visit the investigational center for investigational medicinal product (IMP) administration, safety and efficacy assessments, and blood and urine collections for pharmacokinetics, immunogenicity (anti-drug antibodies \[ADAs\]), and biomarker analyses. Participants will return to the investigational center for a follow-up visit to evaluate ADAs, fremanezumab concentrations, biomarkers, and safety (adverse events and concomitant medications) approximately 7.5 months after the last dose of IMP.
Interventions
- DRUG Fremanezumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2017-04-27 |
| Est. Completion | 2019-06-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03107052
The ClinicalTrials.gov registry entry for NCT03107052 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 275 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fremanezumab is the first listed.
NCT03107052 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03107052 about?
NCT03107052 is a clinical study titled "A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab (TEV-48125) for the Prevention of Cluster Headache". This is a 68-week study to evaluate the long-term safety and efficacy of fremanezumab in participants with cluster headache (CH). Participants who complete the pivotal studies TV48125-CNS-30056 (NCT02945046) and TV48125-CNS-30057 (NCT02964338) and enroll into the current study will visit the investi...
What is the current status of trial NCT03107052?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 275 participants. The study started on 2017-04-27. Estimated completion is 2019-06-11.
What interventions are being tested in trial NCT03107052?
The interventions under investigation include: Fremanezumab (DRUG).
Who is sponsoring clinical trial NCT03107052?
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.