Long-Term Safety Study with TEV-48125 for Cluster Headache Prevention
Research type
Research Study
Full title
A Multicenter, Double-Blind, Double-Dummy Study to Explore the Long-Term Safety of TEV-48125 for the Prevention of Cluster Headache
IRAS ID
216784
Contact name
Peter Goadsby
Contact email
Sponsor organisation
Teva Branded Pharmaceutical Products R&D, Inc.
Eudract number
2016-003172-43
Clinicaltrials.gov Identifier
129606, IND number
Duration of Study in the UK
2 years, 6 months, 0 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 last at least 1 month. However, about 10% to 15% of patients with CH have the Chronic CHs (CCH) form, whereby the cluster period occurs for more than 1 year without remission or with remission lasting less than 1 month. There are no approved medications for the treatment of CH.
Teva is developing TEV-48125 (fremanezumab), a type of protein that blocks calcitonin gene-related peptide (CGRP) action, a substance in the body associated with the functional changes that occur in CH.
This 68-week study will evaluate the long-term safety of TEV-48125 administered subcutaneously (under the skin) to adult patients with CH, who previously participated in TV48125-CNS-30056 or TV48125-CNS-30057.
At visits 1 to 10, Group 1 (of TV48125-CNS-30056 participants) and Group 2 (of TV48125-CNS-30057 participants) will receive 1 subcutaneous injection of TEV-48125 225 mg and 2 subcutaneous injections of placebo. Whereas, Group 2 (of TV48125-CNS-30056 participants) will receive 3 subcutaneous injections of TEV-48125 225 mg at visits 1, 4, 7, and 10 and 1 subcutaneous injection of TEV-48125 225 mg and 2 subcutaneous injections of placebo at visits 2 to 9. Finally, Group 1 (of TV48125-CNS-30057 participants) will receive 3 subcutaneous injections of TEV-48125 of 225 mg at visit 1 and 1 subcutaneous injection of TEV-48125 of 225 mg + 2 injections of placebo at visit 2 to 10.
REC name
London - City & East Research Ethics Committee
REC reference
17/LO/0103
Date of REC Opinion
10 Apr 2017
REC opinion
Further Information Favourable Opinion