Clinical Trials Logo
  1. Home
  2. Cluster Headache
  3. NCT03107052

A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab (TEV-48125) for the Prevention of Cluster Headache — ENFORCE  

Cluster Headache Clinical Trial

Official title:
A Multicenter, Double-Blind, Double-Dummy Study to Explore the Long-Term Safety and Efficacy of TEV-48125 for the Prevention of Cluster Headache

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03107052
Study type Interventional
Source Teva Branded Pharmaceutical Products R&D, Inc.
Contact
Status Terminated
Phase Phase 3
Start date April 27, 2017
Completion date June 11, 2019
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05264714 - Cluster Headache Treatment With Rimegepant Phase 2
Completed NCT01677026 - Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache
Terminated NCT00203190 - A Double-Blind, Placebo-Controlled Study Examining the Use of Topiramate in the Treatment of Cluster Headache Phase 4
Terminated NCT04570475 - High Dose Vitamin D Plus Multivitamin in the Prevention of Cluster Headache Phase 3
Completed NCT04066023 - Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches Phase 2/Phase 3
Withdrawn NCT04353505 - Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache Phase 1
Completed NCT02019017 - Botox Injection in Treatment of Cluster Headache Phase 1/Phase 2
Completed NCT05153876 - An Open Internet-based Survey and Natural Language Processing Project Analysing Written Monologues by Headache Patients
Recruiting NCT05324748 - Repeated GON Injections in CCH Phase 3
Completed NCT02782533 - DBS of the Third Ventricle for Cluster Headache and Obesity N/A
Completed NCT04179266 - Effect of Ketamine Intranasal Spray in Treatment of Chronic Cluster Headache Phase 1/Phase 2
Recruiting NCT04406259 - Atrioventricular Block and Cluster Headache (SEVA) Phase 4
Recruiting NCT06206772 - Resting State Functional Connectivity in Cluster Headache
Recruiting NCT03944876 - Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Cluster Headache Phase 3
Not yet recruiting NCT05857098 - Detection of Local Field Potentials in the Ventral Tegmental Area of the Midbrain in Chronic Cluster Headache Patients
Recruiting NCT02910323 - The Will Erwin Headache Research Center - Cluster Headache Study
Terminated NCT00458770 - Study of Hypothalamic Metabolism in Spontaneous Cluster Headache Attacks N/A
Completed NCT00662935 - Evaluation of Efficacity and Safety of Deep Brain Stimulation (DBS) in Chronic and Treatment-Resistant Cluster Headache(CH) N/A
Active, not recruiting NCT03511846 - Pain Biomarker Study Phase 1
Completed NCT00184587 - Prophylactic Treatment of Episodic Cluster Headache Phase 2