Trials / Terminated
TerminatedNCT03107052
A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab (TEV-48125) for the Prevention of Cluster Headache
A Multicenter, Double-Blind, Double-Dummy Study to Explore the Long-Term Safety and Efficacy of TEV-48125 for the Prevention of Cluster Headache
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 275 (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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fremanezumab | Fremanezumab |
Timeline
- Start date
- 2017-04-27
- Primary completion
- 2019-06-11
- Completion
- 2019-06-11
- First posted
- 2017-04-11
- Last updated
- 2021-11-09
- Results posted
- 2020-05-06
Locations
83 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 NCT03107052. Inclusion in this directory is not an endorsement.