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A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH)

NCT02945046 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2021-11-09

Study results available
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Summary

This is a 13-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group study to compare the efficacy and safety of 2 dose regimens of TEV-48125 (Fremanezumab) versus placebo in adult participants for the prevention of ECH.

Conditions

  • Episodic Cluster Headache

Interventions

DRUG

Fremanezumab

Fremanezumab will be administered per dose and schedule specified in the arm.

DRUG

Placebo

Placebo matching to fremanezumab will be administered per schedule specified in the arm.

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
2017-01-19
Primary Completion
2019-05-13
Completion
2019-05-13
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

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 NCT02945046 on ClinicalTrials.gov