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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: Clinical Trial Phase 2 study, sponsored by Teva Branded Pharmaceutical Products R&D.
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The PI-NRS is an 11-point pain intensity numerical rating scale where 0=no pain and 10=worst possible pain; higher scores indicating more pain. Weekly average of the daily average PI-NRS pain score over the past 24 hours was derived using formula: Summation of non-missing efficacy variable in an analysis week divided by the number of days with non-missing efficacy variable in the analysis week. Baseline was defined as the last 14 days before the first dose of study drug.
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 |
Why NCT03965091 stopped before completion
NCT03965091 is an interventional study that assigns participants to a tested intervention. The registered 189 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03965091 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03965091's enrollment target sits among peer trials
189 355th of 2000 higher than 1,645 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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