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NCT04458857 | COMPLETED | Migraine

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.

Brief 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.

Condition or disease

Migraine

Intervention/treatment

Fremanezumab

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 235 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2020-07-15
Estimated Primary Completion Date : 2024-03-13
Estimated Study Completion Date : 2024-03-13

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 6 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age

Location Details

NCT04458857

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Arkansas

Teva Investigational Site 14281

Little Rock, arkansas, United States, 72202

Not yet recruiting

United States, California

Teva Investigational Site 14253

Banning, California, United States, 92220

Not yet recruiting

United States, California

Teva Investigational Site 14370

Loma Linda, California, United States, 92354

Not yet recruiting

United States, California

Teva Investigational Site 14322

Los Angeles, California, United States, 90027

Not yet recruiting

United States, California

Teva Investigational Site 14361

Sacramento, California, United States, 95815

Not yet recruiting

United States, Colorado

Teva Investigational Site 14319

Aurora, Colorado, United States, 80045

Not yet recruiting

United States, Colorado

Teva Investigational Site 14368

Colorado Springs, Colorado, United States, 80907

Not yet recruiting

United States, Florida

Teva Investigational Site 14244

Jacksonville, florida, United States, 32256

Not yet recruiting

United States, Florida

Teva Investigational Site 14325

Miami, florida, United States, 33155

Not yet recruiting

United States, Florida

Teva Investigational Site 14250

West Palm Beach, florida, United States, 33407

Not yet recruiting

United States, Florida

Teva Investigational Site 14255

West Palm Beach, florida, United States, 33409

Not yet recruiting

United States, Georgia

Teva Investigational Site 14243

Atlanta, Georgia, United States, 30328

Not yet recruiting

United States, Georgia

Teva Investigational Site 14258

Savannah, Georgia, United States, 31406

Not yet recruiting

United States, Illinois

Teva Investigational Site 14263

Hoffman Estates, Illinois, United States, 60169

Not yet recruiting

United States, Illinois

Teva Investigational Site 14283

Park Ridge, Illinois, United States, 60068

Not yet recruiting

United States, Kansas

Teva Investigational Site 14245

Wichita, Kansas, United States, 67206

Not yet recruiting

United States, Kentucky

Teva Investigational Site 14327

Louisville, Kentucky, United States, 40202

Not yet recruiting

United States, Louisiana

Teva Investigational Site 14360

Covington, Louisiana, United States, 70433

Not yet recruiting

United States, Maryland

Teva Investigational Site 14365

Baltimore, Maryland, United States, 21201

Not yet recruiting

United States, Maryland

Teva Investigational Site 14317

Silver Spring, Maryland, United States, 26505

Not yet recruiting

United States, Massachusetts

Teva Investigational Site 14246

Waltham, Massachusetts, United States, 02451

Not yet recruiting

United States, road cancer

Teva Investigational Site 14251

Ann Arbor, road cancer, United States, 48104

Not yet recruiting

United States, Minnesota

Teva Investigational Site 14270

Minneapolis, Minnesota, United States, 55402

Not yet recruiting

United States, Mississippi

Teva Investigational Site 14376

Ridgeland, Mississippi, United States, 39157

Not yet recruiting

United States, Missouri

Teva Investigational Site 14256

Bridgeton, Missouri, United States, 63044-2513

Not yet recruiting

United States, New Jersey

Teva Investigational Site 14371

New Brunswick, New Jersey, United States, 08901

Not yet recruiting

United States, New York

Teva Investigational Site 14276

Amherst, New York, United States, 14226

Not yet recruiting

United States, North Carolina

Teva Investigational Site 14377

Durham, North Carolina, United States, 27710

Not yet recruiting

United States, North Carolina

Teva Investigational Site 14248

Raleigh, North Carolina, United States, 27607

Not yet recruiting

United States, Ohio

Teva Investigational Site 14264

Cincinnati, Ohio, United States, 45229-3039

Not yet recruiting

United States, Oklahoma

Teva Investigational Site 14257

Oklahoma City, Oklahoma, United States, 73112

Not yet recruiting

United States, Oklahoma

Teva Investigational Site 14275

Oklahoma City, Oklahoma, United States, 73116

Not yet recruiting

United States, Oklahoma

Teva Investigational Site 14363

Tulsa, Oklahoma, United States, 74136

Not yet recruiting

United States, Pennsylvania

Teva Investigational Site 14364

Philadelphia, Pennsylvania, United States, 19104-4318

Not yet recruiting

United States, Tennessee

Teva Investigational Site 14374

Bristol, Tennessee, United States, 37620

Not yet recruiting

United States, Texas

Teva Investigational Site 14252

Austin, Texas, United States, 78731

Not yet recruiting

United States, Texas

Teva Investigational Site 14273

Austin, Texas, United States, 78759

Not yet recruiting

United States, Texas

Teva Investigational Site 14274

Bellaire, Texas, United States, 77401

Not yet recruiting

United States, Texas

Teva Investigational Site 14367

dallas, Texas, United States, 75235-7701

Not yet recruiting

United States, Texas

Teva Investigational Site 14312

Houston, Texas, United States, 77087

Not yet recruiting

United States, Texas

Teva Investigational Site 14366

Saint Anthony, Texas, United States, 78207

Not yet recruiting

United States, Texas

Teva Investigational Site 14241

Saint Anthony, Texas, United States, 78240

Not yet recruiting

United States, Utah

Teva Investigational Site 14375

Salt Lake City, Utah, United States, 84109

Not yet recruiting

United States, Virginia

Teva Investigational Site 14323

Norfolk, Virginia, United States, 23510

Not yet recruiting

United States, Washington

Teva Investigational Site 14277

tacoma, Washington, United States, 98405

Not yet recruiting

Canada, Ontario

Teva Investigational Site 11180

Ajax, Ontario, Canada, L1Z 0M1

Not yet recruiting

Canada, Ontario

Teva Investigational Site 11182

Ottawa, Ontario, Canada, K1H 8L1

Not yet recruiting

Canada, Ontario

Teva Investigational Site 11179

Ottawa, Ontario, Canada, K2G 1W2

Not yet recruiting

Canada, Quebec

Teva Investigational Site 11181

Montreal, Quebec, Canada, H4A 3J1

Not yet recruiting

Finland,

Teva Investigational Site 40053

Helsinki, Finland, 00380

Not yet recruiting

Finland,

Teva Investigational Site 40049

Kuopio, Finland, 70210

Not yet recruiting

Finland,

Teva Investigational Site 40054

Oulu, Finland, 90100

Not yet recruiting

Finland,

Teva Investigational Site 40052

Tampere, Finland, 33521

Not yet recruiting

Germany,

Teva Investigational Site 32728

Bad Homburg, Germany, 61350

Not yet recruiting

Germany,

Teva Investigational Site 32729

Berlin, Germany, 13353

Not yet recruiting

Germany,

Teva Investigational Site 32725

Dresden, Germany, 01307

Not yet recruiting

Germany,

Teva Investigational Site 32724

Essen, Germany, 45133

Not yet recruiting

Germany,

Teva Investigational Site 32726

Leipzig, Germany, 04177

Not yet recruiting

Israel,

Teva Investigational Site 80170

Be'er Ya'akov, Israel, 7033001

Not yet recruiting

Israel,

Teva Investigational Site 80166

Haifa, Israel, 3339419

Not yet recruiting

Israel,

Teva Investigational Site 80168

Colon, Israel, 58100

Not yet recruiting

Israel,

Teva Investigational Site 80169

Jerusalem, Israel, 9124001

Not yet recruiting

Israel,

Teva Investigational Site 80167

Ramat Gan, Israel, 5265601

Not yet recruiting

Israel,

Teva Investigational Site 80164

Safed, Israel, 1311001

Not yet recruiting

Israel,

Teva Investigational Site 80165

Tel-Aviv, Israel, 6423906

Not yet recruiting

Italy,

Teva Investigational Site 30230

Firenze, Italy, 50139

Not yet recruiting

Italy,

Teva Investigational Site 30239

Milano, Italy, 20132

Not yet recruiting

Italy,

Teva Investigational Site 30228

Milano, Italy, 20133

Not yet recruiting

Italy,

Teva Investigational Site 30226

Milano, Italy, 20148

Not yet recruiting

Italy,

Teva Investigational Site 30238

Padua, Italy, 35128

Not yet recruiting

Italy,

Teva Investigational Site 30227

Pavia, Italy, 27100

Not yet recruiting

Italy,

Teva Investigational Site 30225

Rome, Italy, 00163

Not yet recruiting

Netherlands,

Teva Investigational Site 38138

Doetinchem, Netherlands, 7009 BL

Not yet recruiting

Netherlands,

Teva Investigational Site 38135

Nijmegen, Netherlands, 6532 SZ

Not yet recruiting

Netherlands,

Teva Investigational Site 38136

Rotterdam, Netherlands, 3015 GD

Not yet recruiting

Poland,

Teva Investigational Site 53441

Gdansk, Poland, 80-389

Not yet recruiting

Poland,

Teva Investigational Site 53437

Kielce, Poland, 25-316

Not yet recruiting

Poland,

Teva Investigational Site 53443

Krakow, Poland, 30-363

Not yet recruiting

Poland,

Teva Investigational Site 53452

Krakow, Poland, 30-539

Not yet recruiting

Poland,

Teva Investigational Site 53440

Lublin, Poland, 20-582

Not yet recruiting

Poland,

Teva Investigational Site 53439

Poznan, Poland, 60-355

Not yet recruiting

Poland,

Teva Investigational Site 53451

Poznan, Poland, 61-731

Not yet recruiting

Poland,

Teva Investigational Site 53442

Szczecin, Poland, 70-111

Not yet recruiting

Spain,

Teva Investigational Site 31271

Barcelona, Spain, 08035

Not yet recruiting

Spain,

Teva Investigational Site 31266

Cooking, Spain, 03600

Not yet recruiting

Spain,

Teva Investigational Site 31268

Madrid, Spain, 28007

Not yet recruiting

Spain,

Teva Investigational Site 31267

Madrid, Spain, 28046

Not yet recruiting

Spain,

Teva Investigational Site 31270

Valencia, Spain, 46026

Not yet recruiting

Spain,

Teva Investigational Site 31265

Valladolid, Spain, 47010