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NCT04458857

PHASE3

A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

Summary

The primary objective of the study is to evaluate the efficacy of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM). Secondary objectives are to further demonstrate the efficacy of fremanezumab as compared to placebo for the preventive treatment of EM, to evaluate the safety and tolerability of fremanezumab in the preventive treatment of EM and to evaluate the immunogenicity of fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to fremanezumab. The total duration of the study is planned to be up to 51 months.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Episodic Migraine in Pediatric Patients 6 to 17 Years of Age

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

235

Start Date

2020-07-15

Completion Date

2024-03-13

Last Updated

2026-06-22

Healthy Volunteers

Conditions

Migraine

Interventions

DRUG

Fremanezumab

Dose A or Dose B subcutaneous

DRUG

Placebo

Matching placebo

Inclusion Criteria: * The participant has a clinical history of recurrent headache consistent with the diagnosis of migraine for at least 6 months before screening, consistent with ICHD-3 criteria (Headache Classification Committee of the IHS 2013), and a history of ≤=14 headache days per month in each of the 3 months prior to screening (visit 1). * The participant or parent/caregiver maintain a prospectively collected headache diary * The participant does not have chronic daily headache. For the purposes of this study, chronic daily headache is operationally defined as \<4 headache-free days during the 28-day baseline period. NOTE: Additional criteria apply; please contact the investigator for more information. Exclusion Criteria: * The participant is using medications containing opioids (including codeine) or barbiturates (including Fiorinal®, Fioricet®, or any other combination containing butalbital) for the treatment of migraine during the 3 months prior to the day of the screening visit. * The participant or parent/caregiver maintain a prospectively collected headache diary * The participant has used an intervention/device (eg, scheduled nerve block or transcranial magnetic stimulation) for the treatment of migraine or in the head or neck area for any condition during the 2 months prior to the day of the screening visit. * The participant has a current history of a clinically significant psychiatric condition, at the discretion of the investigator. Any prior history of a suicide attempt, or a history of suicidal ideation with a specific plan within the past 2 years, must be excluded. * The participant has an ongoing infection or a known history of human immunodeficiency virus infection, tuberculosis, Lyme disease, or chronic hepatitis B or C, or a known active infection of coronavirus disease 2019 (COVID-19). * The participant has a past or current history of cancer. * The participant is pregnant or nursing. * The participant has a history of hypersensitivity reactions to injected proteins, including mAbs, or a history of Stevens-Johnson Syndrome or toxic epidermal necrolysis syndrome, or the participant is concomitantly using lamotrigine. * The participant received a live attenuated vaccine (eg, intranasal flu vaccine, and measles, mumps, and rubella vaccine) within the 12-week period prior to screening. Note: If a medical need arises during the study, the participant may receive a live attenuated vaccine. * The participant has a current or past medical history of hemiplegic migraine. NOTE: Additional criteria apply; please contact the investigator for more information.

Locations (89)

Teva Investigational Site 14281

Little Rock, Arkansas, United States

Teva Investigational Site 14253

Banning, California, United States

Teva Investigational Site 14370

Loma Linda, California, United States

Teva Investigational Site 14322

Los Angeles, California, United States

Teva Investigational Site 14361

Sacramento, California, United States

Teva Investigational Site 14319

Aurora, Colorado, United States

Teva Investigational Site 14368

Colorado Springs, Colorado, United States

Teva Investigational Site 14244

Jacksonville, Florida, United States

Teva Investigational Site 14325

Miami, Florida, United States

Teva Investigational Site 14250

West Palm Beach, Florida, United States

Teva Investigational Site 14255

West Palm Beach, Florida, United States

Teva Investigational Site 14243

Atlanta, Georgia, United States

Teva Investigational Site 14258

Savannah, Georgia, United States

Teva Investigational Site 14263

Hoffman Estates, Illinois, United States

Teva Investigational Site 14283

Park Ridge, Illinois, United States

Teva Investigational Site 14245

Wichita, Kansas, United States

Teva Investigational Site 14327

Louisville, Kentucky, United States

Teva Investigational Site 14360

Covington, Louisiana, United States

Teva Investigational Site 14365

Baltimore, Maryland, United States

Teva Investigational Site 14317

Silver Spring, Maryland, United States

Teva Investigational Site 14246

Waltham, Massachusetts, United States

Teva Investigational Site 14251

Ann Arbor, Michigan, United States

Teva Investigational Site 14270

Minneapolis, Minnesota, United States

Teva Investigational Site 14376

Ridgeland, Mississippi, United States

Teva Investigational Site 14256

Bridgeton, Missouri, United States

Teva Investigational Site 14371

New Brunswick, New Jersey, United States

Teva Investigational Site 14276

Amherst, New York, United States

Teva Investigational Site 14377

Durham, North Carolina, United States

Teva Investigational Site 14248

Raleigh, North Carolina, United States

Teva Investigational Site 14264

Cincinnati, Ohio, United States

Teva Investigational Site 14257

Oklahoma City, Oklahoma, United States

Teva Investigational Site 14275

Oklahoma City, Oklahoma, United States

Teva Investigational Site 14363

Tulsa, Oklahoma, United States

Teva Investigational Site 14364

Philadelphia, Pennsylvania, United States

Teva Investigational Site 14374

Bristol, Tennessee, United States

Teva Investigational Site 14252

Austin, Texas, United States

Teva Investigational Site 14273

Austin, Texas, United States

Teva Investigational Site 14274

Bellaire, Texas, United States

Teva Investigational Site 14367

Dallas, Texas, United States

Teva Investigational Site 14312

Houston, Texas, United States

Teva Investigational Site 14366

San Antonio, Texas, United States

Teva Investigational Site 14241

San Antonio, Texas, United States

Teva Investigational Site 14375

Salt Lake City, Utah, United States

Teva Investigational Site 14323

Norfolk, Virginia, United States

Teva Investigational Site 14277

Tacoma, Washington, United States

Teva Investigational Site 11180

Ajax, Ontario, Canada

Teva Investigational Site 11182

Ottawa, Ontario, Canada

Teva Investigational Site 11179

Ottawa, Ontario, Canada

Teva Investigational Site 11181

Montreal, Quebec, Canada

Teva Investigational Site 40053

Helsinki, Finland

Teva Investigational Site 40049

Kuopio, Finland

Teva Investigational Site 40054

Oulu, Finland

Teva Investigational Site 40052

Tampere, Finland

Teva Investigational Site 32728

Bad Homburg, Germany

Teva Investigational Site 32729

Berlin, Germany

Teva Investigational Site 32725

Dresden, Germany

Teva Investigational Site 32724

Essen, Germany

Teva Investigational Site 32726

Leipzig, Germany

Teva Investigational Site 80170

Be’er Ya‘aqov, Israel

Teva Investigational Site 80166

Haifa, Israel

Teva Investigational Site 80168

Holon, Israel

Teva Investigational Site 80169

Jerusalem, Israel

Teva Investigational Site 80167

Ramat Gan, Israel

Teva Investigational Site 80164

Safed, Israel

Teva Investigational Site 80165

Tel Aviv, Israel

Teva Investigational Site 30230

Florence, Italy

Teva Investigational Site 30239

Milan, Italy

Teva Investigational Site 30228

Milan, Italy

Teva Investigational Site 30226

Milan, Italy

Teva Investigational Site 30238

Padua, Italy

Teva Investigational Site 30227

Pavia, Italy

Teva Investigational Site 30225

Rome, Italy

Teva Investigational Site 38138

Doetinchem, Netherlands

Teva Investigational Site 38135

Nijmegen, Netherlands

Teva Investigational Site 38136

Rotterdam, Netherlands

Teva Investigational Site 53441

Gdansk, Poland

Teva Investigational Site 53437

Kielce, Poland

Teva Investigational Site 53443

Krakow, Poland

Teva Investigational Site 53452

Krakow, Poland

Teva Investigational Site 53440

Lublin, Poland

Teva Investigational Site 53439

Poznan, Poland

Teva Investigational Site 53451

Poznan, Poland

Teva Investigational Site 53442

Szczecin, Poland

Teva Investigational Site 31271

Barcelona, Spain

Teva Investigational Site 31266

Elda, Spain

Teva Investigational Site 31268

Madrid, Spain

Teva Investigational Site 31267

Madrid, Spain

Teva Investigational Site 31270

Valencia, Spain

Teva Investigational Site 31265

Valladolid, Spain

Clinical Research Directory

A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (89)