Trials / Terminated
TerminatedNCT02945046
A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH)
A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens (Intravenous/Subcutaneous and Subcutaneous) of TEV-48125 Versus Placebo for the Prevention of Epidosic Cluster Headache
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 169 (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fremanezumab | Fremanezumab will be administered per dose and schedule specified in the arm. |
| DRUG | Placebo | Placebo matching to fremanezumab will be administered per schedule specified in the arm. |
Timeline
- Start date
- 2017-01-19
- Primary completion
- 2019-05-13
- Completion
- 2019-05-13
- First posted
- 2016-10-26
- Last updated
- 2021-11-09
- Results posted
- 2020-04-13
Locations
82 sites across 12 countries: United States, Australia, Canada, Finland, Germany, Israel, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02945046. Inclusion in this directory is not an endorsement.