Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03965091 · ClinicalTrials.gov registry record · Phase 2
A Study to Test the Effectiveness and Safety of Fremanezumab on Participants With Fibromyalgia
A Phase 2 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Terminated
- Registry status
- Phase 2
- Development phase
- 189
- Enrollment target
NCT03965091 is a Phase 2 study that was terminated before completion, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 189 participants.
The verdict
NCT03965091, a Phase 2 study, was terminated before completion, sponsored by Teva Branded Pharmaceutical Products R&D.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 189 participants
- Enrollment target
Study Summary
The primary objective of the study is to estimate the treatment effect of fremanezumab administered subcutaneously (SC) in reducing pain in adult participants with fibromyalgia (FM). A secondary objective is to evaluate the effect of fremanezumab on other efficacy measures, including pain, quality of life, sleep, fatigue, improvement in health, physical functioning, and mood. Another secondary objective is to evaluate the safety and tolerability of fremanezumab administered SC in adult participants with FM. The total duration of participant participation in the study is planned to be 21 weeks, consisting of a screening period of up to 5 weeks (ranging from 17 to 35 days), and a double-blind treatment period of 16 weeks.
Interventions
- DRUG Placebo
- DRUG Fremanezumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 189 participants |
| Start Date | 2019-07-31 |
| Est. Completion | 2022-01-19 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03965091
The ClinicalTrials.gov registry entry for NCT03965091 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 189 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 2 interventions - of which Placebo is the first listed.
NCT03965091 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03965091 about?
NCT03965091 is a clinical study titled "A Study to Test the Effectiveness and Safety of Fremanezumab on Participants With Fibromyalgia". The primary objective of the study is to estimate the treatment effect of fremanezumab administered subcutaneously (SC) in reducing pain in adult participants with fibromyalgia (FM). A secondary objective is to evaluate the effect of fremanezumab on other efficacy measures, including pain, quality o...
What is the current status of trial NCT03965091?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 189 participants. The study started on 2019-07-31. Estimated completion is 2022-01-19.
What interventions are being tested in trial NCT03965091?
The interventions under investigation include: Placebo (DRUG), Fremanezumab (DRUG).
Who is sponsoring clinical trial NCT03965091?
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.