A Study Comparing the Efficacy and Safety of Fremanezumab (TEV-48125) for the Prevention of Chronic Cluster Headache (CCH)

NCT02964338 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 259

Last updated 2021-11-09

Study results available
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Summary

The purpose of the current study is to evaluate the efficacy and safety of Fremanezumab (TEV-48125), in the prevention of CCH in adult participants.

Conditions

  • Chronic Cluster Headache

Interventions

DRUG

Fremanezumab

Fremanezumab will be administered as per the dose and schedule specified in the respective arms.

DRUG

Placebo

Placebo matching to fremanezumab will be administered as per the schedule specified in the respective arms.

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-17
Primary Completion
2018-07-18
Completion
2018-07-18
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Finland
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02964338 on ClinicalTrials.gov