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

NCT ID: NCT03107052

Last Updated: 2021-11-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-27

Study Completion Date

2019-06-11

Brief Summary

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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.

Detailed Description

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Conditions

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Cluster Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fremanezumab 225 mg Monthly

Participants with ECH or CCH who received fremanezumab at 900 mg intravenous (IV) infusion at Week 0 and fremanezumab at 225 mg subcutaneous (SC) injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30056 or TV48125-CNS-30057, and participants with CCH who received fremanezumab at 675 mg SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30057; will receive fremanezumab at 225 mg SC injection monthly (approximately every 4 weeks, administered as single SC injection of fremanezumab at 225 mg \[225 mg/1.5 milliliter {mL}\] at Week 0 and 36; and 2 placebo SC injections at Weeks 0, 12, 24, and 36 for blinding in participants rolled over from Study TV48125-CNS-30056; fremanezumab at 225 mg as a single SC injection (225 mg/1.5 mL) at Week 0, 12, 24, and 36; 2 SC injections of placebo at Week 0 for blinding in participants rolled over from Study TV48125-CNS-30057) through Week 36 in this study.

Group Type EXPERIMENTAL

Fremanezumab

Intervention Type DRUG

Fremanezumab

Fremanezumab 675/225 mg Monthly

Participants with CCH who received placebo IV infusion and SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30057; will receive fremanezumab 675 mg SC injection as loading dose (administered as 3 SC injections of fremanezumab at 225 mg \[225 mg/1.5 mL\] at Week 0) followed by monthly (approximately every 4 weeks) fremanezumab at 225 mg SC injection (administered as single SC injection of fremanezumab at 225 mg \[225 mg/1.5 mL\] at Weeks 12, 24, and 36) through Week 36.

Group Type EXPERIMENTAL

Fremanezumab

Intervention Type DRUG

Fremanezumab

Fremanezumab 675 mg Quarterly

Participants with ECH who received fremanezumab at 675 mg SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study; or placebo IV infusion and SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30056; will receive fremanezumab at 675 mg SC injection quarterly (approximately every 12 weeks, administered as 3 SC injections of fremanezumab at 225 mg \[225 mg/1.5 mL\] at Weeks 0 an 36; and single placebo SC injections at Weeks 4, 8, 16, 20, 28, and 32 for blinding) through Week 36.

Group Type EXPERIMENTAL

Fremanezumab

Intervention Type DRUG

Fremanezumab

Interventions

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Fremanezumab

Fremanezumab

Intervention Type DRUG

Other Intervention Names

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TEV-48125

Eligibility Criteria

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Inclusion Criteria

* The participant 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 participant safety and participant compliance.
* Prior to 15 June 2018, participants from the ECH study and the CCH study were enrolled. After 15 June 2018, only participants who participated in the ECH study (Study TV48125-CNS-30056) will be enrolled for active treatment.
* In addition, participants who do not complete the pivotal efficacy studies, and participants 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

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Teva Investigational Site 13834

Phoenix, Arizona, United States

Site Status

Teva Investigational Site 13819

Canoga Park, California, United States

Site Status

Teva Investigational Site 13811

Santa Monica, California, United States

Site Status

Teva Investigational Site 13823

Stanford, California, United States

Site Status

Teva Investigational Site 13837

Aurora, Colorado, United States

Site Status

Teva Investigational Site 13814

Colorado Springs, Colorado, United States

Site Status

Teva Investigational Site 13836

Denver, Colorado, United States

Site Status

Teva Investigational Site 13813

Englewood, Colorado, United States

Site Status

Teva Investigational Site 13821

New Haven, Connecticut, United States

Site Status

Teva Investigational Site 13812

Stamford, Connecticut, United States

Site Status

Teva Investigational Site 13810

Gainesville, Florida, United States

Site Status

Teva Investigational Site 13815

Orlando, Florida, United States

Site Status

Teva Investigational Site 13829

Ormond Beach, Florida, United States

Site Status

Teva Investigational Site 13830

St. Petersburg, Florida, United States

Site Status

Teva Investigational Site 13842

Tampa, Florida, United States

Site Status

Teva Investigational Site 13840

Tampa, Florida, United States

Site Status

Teva Investigational Site 13833

Columbus, Georgia, United States

Site Status

Teva Investigational Site 13826

Chicago, Illinois, United States

Site Status

Teva Investigational Site 13818

Ann Arbor, Michigan, United States

Site Status

Teva Investigational Site 13835

Las Vegas, Nevada, United States

Site Status

Teva Investigational Site 13832

Las Vegas, Nevada, United States

Site Status

Teva Investigational Site 13831

Lebanon, New Hampshire, United States

Site Status

Teva Investigational Site 13820

Princeton, New Jersey, United States

Site Status

Teva Investigational Site 13827

Albuquerque, New Mexico, United States

Site Status

Teva Investigational Site 13816

Amherst, New York, United States

Site Status

Teva Investigational Site 13817

New York, New York, United States

Site Status

Teva Investigational Site 13809

Raleigh, North Carolina, United States

Site Status

Teva Investigational Site 13839

Salisbury, North Carolina, United States

Site Status

Teva Investigational Site 13825

Cleveland, Ohio, United States

Site Status

Teva Investigational Site 13824

Philadelphia, Pennsylvania, United States

Site Status

Teva Investigational Site 13841

Richmond, Texas, United States

Site Status

Teva Investigational Site 13822

Virginia Beach, Virginia, United States

Site Status

Teva Investigational Site 78120

Auchenflower, , Australia

Site Status

Teva Investigational Site 78118

Clayton, , Australia

Site Status

Teva Investigational Site 78123

Melbourne, , Australia

Site Status

Teva Investigational Site 78122

Parkville, , Australia

Site Status

Teva Investigational Site 78121

Randwick, , Australia

Site Status

Teva Investigational Site 11132

Newmarket, Ontario, Canada

Site Status

Teva Investigational Site 11130

Calgary, , Canada

Site Status

Teva Investigational Site 40030

Helsinki, , Finland

Site Status

Teva Investigational Site 40031

Oulu, , Finland

Site Status

Teva Investigational Site 40029

Turku, , Finland

Site Status

Teva Investigational Site 32666

Berlin, , Germany

Site Status

Teva Investigational Site 32667

Bochum, , Germany

Site Status

Teva Investigational Site 32660

Essen, , Germany

Site Status

Teva Investigational Site 32665

Hamburg, , Germany

Site Status

Teva Investigational Site 32662

Kiel, , Germany

Site Status

Teva Investigational Site 32661

Königstein im Taunus, , Germany

Site Status

Teva Investigational Site 32663

Rostock, , Germany

Site Status

Teva Investigational Site 80124

Ashkelon, , Israel

Site Status

Teva Investigational Site 80122

Hadera, , Israel

Site Status

Teva Investigational Site 80125

Holon, , Israel

Site Status

Teva Investigational Site 80121

Jerusalem, , Israel

Site Status

Teva Investigational Site 80123

Netanya, , Israel

Site Status

Teva Investigational Site 80120

Ramat Gan, , Israel

Site Status

Teva Investigational Site 80127

Tel Aviv, , Israel

Site Status

Teva Investigational Site 80126

Tel Aviv, , Israel

Site Status

Teva Investigational Site 30190

Milan, , Italy

Site Status

Teva Investigational Site 30192

Modena, , Italy

Site Status

Teva Investigational Site 30194

Napoli, , Italy

Site Status

Teva Investigational Site 30193

Pavia, , Italy

Site Status

Teva Investigational Site 30191

Rome, , Italy

Site Status

Teva Investigational Site 30189

Rome, , Italy

Site Status

Teva Investigational Site 38118

Leiden, , Netherlands

Site Status

Teva Investigational Site 38119

Nijmegen, , Netherlands

Site Status

Teva Investigational Site 38117

Zwolle, , Netherlands

Site Status

Teva Investigational Site 53380

Bialystok, , Poland

Site Status

Teva Investigational Site 53383

Krakow, , Poland

Site Status

Teva Investigational Site 53379

Krakow, , Poland

Site Status

Teva Investigational Site 53382

Lodz, , Poland

Site Status

Teva Investigational Site 53381

Szczecin, , Poland

Site Status

Teva Investigational Site 31211

Galdakao, , Spain

Site Status

Teva Investigational Site 31214

Madrid, , Spain

Site Status

Teva Investigational Site 31213

Seville, , Spain

Site Status

Teva Investigational Site 31212

Valladolid, , Spain

Site Status

Teva Investigational Site 31215

Zaragoza, , Spain

Site Status

Teva Investigational Site 42047

Huddinge, , Sweden

Site Status

Teva Investigational Site 42045

Vällingby, , Sweden

Site Status

Teva Investigational Site 34224

Glasgow, , United Kingdom

Site Status

Teva Investigational Site 34222

Liverpool, , United Kingdom

Site Status

Teva Investigational Site 34223

London, , United Kingdom

Site Status

Teva Investigational Site 34220

London, , United Kingdom

Site Status

Teva Investigational Site 34221

Oxford, , United Kingdom

Site Status

Countries

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

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2016-003172-43

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TV48125-CNS-30058

Identifier Type: -

Identifier Source: org_study_id