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

This study is currently recruiting participants.
Verified September 2017 by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02945046
First Posted: October 26, 2016
Last Update Posted: October 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
  Purpose
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 patients for the prevention of ECH.

Condition Intervention Phase
Episodic Cluster Headache Drug: Fremanezumab - A Drug: Fremanezumab - B Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ):

Primary Outcome Measures:
  • the mean change from baseline (run-in period) in the weekly average number of cluster headache (CH) attacks during the 4-week period after administration of the first dose of the investigational medicinal product (IMP) [ Time Frame: Week 0 to 4 ]

Secondary Outcome Measures:
  • the mean change from baseline in the number of CH attacks during the 4-week period after administration of the first dose [ Time Frame: Week 0 to 4 ]
  • the mean change from baseline in the number of CH attacks during the 12-week period after administration of the first dose [ Time Frame: Week 0 to 12 ]
  • the proportion of patients with a ≥50% reduction from baseline (run-in period) in the weekly average number of CH attacks during the 4-week period after the first dose of the IMP [ Time Frame: Week 0 to 4 ]
  • the mean change from baseline (run-in period) in the number of CH attacks during the 12-week period after administration of the first dose of the IMP [ Time Frame: Week 0 to 12 ]

Estimated Enrollment: 300
Actual Study Start Date: November 30, 2016
Estimated Study Completion Date: June 30, 2018
Estimated Primary Completion Date: May 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fremanezumab - A
Drug Regimen 1
Drug: Fremanezumab - A
Other Name: TEV-48125
Experimental: Fremanezumab - B
Drug Regimen 2
Drug: Fremanezumab - B
Other Name: TEV-48125
Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo
Matching placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   17 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has a history of ECH according to the International Classification of Headache Disorders - 3 beta criteria (Headache Classification Committee of the IHS 2013) for ≥12 months prior to screening
  • The patient has a total body weight of ≥45 kg (99 lbs.)
  • The patient is in good health in the opinion of the investigator
  • Women of childbearing potential (WOCBP) whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the study
  • Men must be sterile, or if they are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners are of childbearing potential, must agree to use, together with their female partners, acceptable birth control
  • If a patient is receiving Botox, it should be in a stable dose regimen, considered as having ≥2 cycles of Botox prior to screening. The patient should not receive Botox during the run-in period up to the evaluation period (4 weeks) where the primary endpoint is evaluated.

    • Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • The patient has used systemic steroids for any medical reason (including treatment of the current CH cycle within ≤7 days prior to screening The patient has used an intervention/device (eg, scheduled nerve blocks) for headache during the 4 weeks prior to screening.
  • The patient has clinically significant hematological, renal, endocrine, immunologic, pulmonary, gastrointestinal, genitourinary, cardiovascular, neurologic, hepatic, or ocular disease at the discretion of the investigator.
  • The patient has evidence or medical history of clinically significant psychiatric issues determined at the discretion of the investigator.
  • The patient has a past or current history of cancer or malignant tumor in the past 5 years, except for appropriately treated non-melanoma skin carcinoma.
  • The patient is pregnant or lactating.
  • The patient has a history of hypersensitivity reactions to injected proteins, including monoclonal antibodies.
  • The patient has participated in a clinical study of a monoclonal antibody within 3 months or 5 half-lives before administration of the first dose of the IMP, whichever is longer, unless it is known that the patient received placebo during the study.
  • The patient has a history of prior exposure to a monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) pathway (AMG 334, ALD304, LY2951742, or fremanezumab). If patient has participated in a clinical study with any of these monoclonal antibodies, it has to be confirmed that the patient received placebo in order to be eligible for this study.
  • The patient is an employee of the sponsor/participating study center who is directly involved in the study or is the relative of such an employee.
  • The patient has an active implant for neurostimulation used in the treatment of CH.
  • The patient is a member of a vulnerable population (eg, people kept in detention).
  • The patient has a history of alcohol abuse prior to screening and/or drug abuse that in the investigator's opinion could interfere with the study evaluations or the patient's safety .

    • Additional criteria apply, please contact the investigator for more information
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945046


Contacts
Contact: Teva U.S. Medical Information 1-888-483-8279

  Show 86 Study Locations
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Teva Medical Expert, MD TEVA
  More Information

Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT02945046     History of Changes
Other Study ID Numbers: TV48125-CNS-30056
2016-003278-42 ( EudraCT Number )
First Submitted: October 25, 2016
First Posted: October 26, 2016
Last Update Posted: October 3, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Headache
Cluster Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases