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

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ClinicalTrials.gov Identifier: NCT03107052
Recruitment Status : Terminated (The study was terminated after the episodic cluster study was terminated due to a pre specified futility analyses)
First Posted : April 11, 2017
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Brief Summary:
This is a 68-week study to evaluate the long-term safety and efficacy of fremanezumab in patients with CH. Patients who complete the pivotal studies and enroll into the current study will visit the investigational center for IMP administration, safety and efficacy assessments, and blood and urine collections for pharmacokinetics, immunogenicity (ADAs), and biomarker analyses. Patients 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.

Condition or disease Intervention/treatment Phase
Cluster Headache Drug: Fremanezumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 311 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 27, 2017
Actual Primary Completion Date : June 11, 2019
Actual Study Completion Date : June 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: Fremanezumab - A
Fremanezumab at 225 mg sc monthly (approximately every 4 weeks) through week 36
Drug: Fremanezumab
Fremanezumab
Other Name: TEV-48125

Experimental: Fremanezumab - B
Fremanezumab at 675 mg sc quarterly (approximately every 12 weeks) through week 36
Drug: Fremanezumab
Fremanezumab
Other Name: TEV-48125

Experimental: Fremanezumab - C
Fremanezumab 675-mg sc loading dose followed by monthly (approximately every 4 weeks) fremanezumab at 225 mg sc through week 36
Drug: Fremanezumab
Fremanezumab
Other Name: TEV-48125




Primary Outcome Measures :
  1. occurrence of adverse events throughout the study [ Time Frame: from baseline (day 0 of the Phase 3 pivotal efficacy studies) to week 36 ]
    occurrence of adverse events throughout the study

  2. occurrence of injection site reactions (ie, erythema, induration, and ecchymosis) [ Time Frame: from baseline (day 0 of the Phase 3 pivotal efficacy studies) to week 36 ]
    Graded according to measurements: absent, 5 mm to ≤50 mm (mild), >50 to ≤100 mm (moderate), and >100 mm (severe).

  3. use of concomitant medications during the study [ Time Frame: from baseline (day 0 of the Phase 3 pivotal efficacy studies) to week 36 ]
    All concomitant medications taken during the study must be recorded with indication, daily dose, and start and stop dates of administration. All patients will be questioned about concomitant medication at each visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient completes either the Phase 3 pivotal study for ECH (Study TV48125-CNS-30056) or the Phase 3 pivotal study for CCH (Study TV48125-CNS-30057) without important protocol deviations related to patient safety and patient compliance.
  • Prior to 15 June 2018, patients from the ECH study and the CCH study were enrolled. After 15 June 2018, only patients who participated in the ECH study (Study TV48125-CNS-30056) will be enrolled for active treatment.
  • In addition, patients who do not complete the pivotal efficacy studies, and patients who complete the pivotal efficacy studies but will not continue treatment during this long-term safety study, will be offered to enroll in this study for the purpose of evaluating ADAs, and safety (adverse events and concomitant medications) approximately 7.5 months after administration of the last dose of the IMP.

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

Exclusion Criteria:

  • Any finding that, in the judgment of the investigator, is a clinically significant abnormality, including serum chemistry, hematology, coagulation, and urinalysis test values (abnormal tests may be repeated for confirmation)

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

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): NCT03107052


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Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
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Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA

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Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT03107052     History of Changes
Other Study ID Numbers: TV48125-CNS-30058
2016-003172-43 ( EudraCT Number )
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cluster Headache
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs