Trials / Completed
CompletedNCT02021773
Assessment of LBR-101 In Chronic Migraine
A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group, Multi-dose Study Comparing the Efficacy and Safety of Subcutaneous LBR-101 With Placebo for the Preventive Treatment of Chronic Migraine
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 264 (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to determine whether monthly subcutaneous administration of LBR-101 (fremanezumab) is safe and provides migraine prevention in patients with chronic migraine.
Detailed description
Two distinct doses of subcutaneous LBR-101 (fremanezumab) administered monthly will be compared to placebo for safety and efficacy. The mean change from baseline in the number of cumulative headache hours measured at the 28-day period ending with week 12.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LBR-101 High Dose | Subcutaneously Administered LBR-101 Monthly x 3 |
| DRUG | LBR-101 Low Dose | Subcutaneously Administered LBR-101 Monthly x 3 |
| DRUG | Placebo | Subcutaneously Administered Placebo (Vehicle) Monthly x 3 |
Timeline
- Start date
- 2014-01-31
- Primary completion
- 2015-02-28
- Completion
- 2015-03-31
- First posted
- 2013-12-27
- Last updated
- 2021-12-09
- Results posted
- 2021-11-01
Locations
57 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02021773. Inclusion in this directory is not an endorsement.