Conditions: Chronic Migraine
Keywords: Headache Migraine Chronic Migraine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 264
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Subcutaneous High Dose LBR-101 Administered Monthly x 3 arm 2: Subcutaneous Low Dose LBR-101 Administered Monthly x 3 arm 3: Subcutaneous Placebo Administered Monthly x 3

Interventions: intervention 1: LBR-101 High Dose intervention 2: LBR-101 Low Dose intervention 3: Placebo
Intervention descriptions: intervention 1: Subcutaneously Administered LBR-101 Monthly x 3 intervention 2: Subcutaneously Administered LBR-101 Monthly x 3 intervention 3: Subcutaneously Administered Placebo (Vehicle) Monthly x 3

Protocol document: