Placebo controlled study with TEV-48125 for EC Headaches
Research type
Research Study
Full title
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 Episodic Cluster Headache
IRAS ID
215087
Contact name
Peter Goadsby
Contact email
Sponsor organisation
Teva Branded Pharmaceutical Products R&D, Inc.
Eudract number
2016-003278-42
Clinicaltrials.gov Identifier
129606, IND number
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
Cluster headaches (CH) are excruciating attacks of pain in one side of the head, often felt around the eye. They’re estimated to affect around 1 in 500-1,000 people. Attacks last up to 180 minutes and occur from once every other day to 8 times a day. Cluster periods usually last a few months (typically 3 months) followed by headache-free periods of months to years. Episodic CHs (ECH) are the most common form where distinct pain-free periods lasting at least 1 month are evident. The cause of CH is complex and not fully understood. Worldwide, there are currently no approved medications for the preventative treatment of CH.
Calcitonin gene-related peptide (CGRP) is a substance in the body associated with the functional changes that occur in CH. Teva is developing TEV-48125 (fremanezumab), a type of protein (called an antibody), that blocks the action of calcitonin gene-related peptide (CGRP).
This 13-week study will look at how well this study medication works and how safe it is in adult ECH patients. Participants will be randomly assigned to 1 of 3 treatment groups. At visit 1: Group 1 will receive 1 hour of intravenous infusion of TEV-48125 900 mg followed by 3 subcutaneous (under the skin) injections of placebo, Group 2 will receive 1 hour of intravenous infusion of placebo followed by 3 subcutaneous injections of TEV-48125 225 mg and Group 3 will receive both placebo infusion and injections. At visits 3 and 4: Group 1 will receive 1 subcutaneous injection of TEV-48125 225 mg whereas Groups 2 and 3 will receive 1 subcutaneous injection of placebo.
Participants will undergo a number of assessments at each of the 5 study visits. This will include blood sampling, electrocardiograms and completing a number of questionnaires.
REC name
London - City & East Research Ethics Committee
REC reference
17/LO/0101
Date of REC Opinion
9 Apr 2017
REC opinion
Further Information Favourable Opinion