Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: Fremanezumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02621931

TV48125-CNS-30049

2015-004549-23 (EudraCT Number)

Details and patient eligibility

About

The study is being conducted to evaluate two doses of TEV-48125 in adult patients with chronic migraine

Enrollment: 1,130 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females aged 18 to 70 years, inclusive, with migraine onset at ≤50 years of age

• Patient signs and dates the informed consent document

• Patient has history of migraine according to International Classification of Headache Disorders, or clinical judgment suggests a migraine diagnosis

• 85% e-diary compliance

• Total body weight between 99 and 250 lbs, inclusive

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

Exclusion criteria

• Clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease, at the discretion of the investigator

• Evidence or medical history of clinically significant psychiatric issues, including any suicide attempt in the past, or suicidal ideation with a specific plan in the past 2 years

• History of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological [eg, cerebral ischemia], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events), such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism

• Known infection or history of human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection

• Past or current history of cancer in the last 5 years, except for appropriately treated nonmelanoma skin carcinoma

• Pregnant or nursing females

• History of hypersensitivity reactions to injected proteins, including monoclonal antibodies

• Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months prior to study drug administration or 5 half-lives, whichever is longer

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,130 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matching Placebo

Treatment:

Drug: Placebo

Fremanezumab 675 mg/placebo/placebo

Experimental group

Description:

Participants randomized to the fremanezumab 675 mg/placebo/placebo treatment arm received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.

Treatment:

Drug: Fremanezumab

Drug: Placebo

Fremanezumab 675/225/225 mg

Experimental group

Description:

Participants randomized to the fremanezumab 675/225/225 mg treatment arm received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0 and 225 mg of fremanezumab as 1 active injection (225 mg/1.5 mL) on Days 28 and 56.

Treatment:

Drug: Fremanezumab