Phase 3
N=1,130
Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT02621931 ↗Enrolled (actual)
1,130
Serious AEs
1.2%
Results posted
Dec 2018
Primary outcome: Primary: Change From Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity During the 12-Week Period After the First Dose of Study Drug — -2.5; -4.2; -4.5 days — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fremanezumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity During the 12-Week Period After the First Dose of Study Drug |
-2.5; -4.2; -4.5 | <0.0001 sig |
| PRIMARY Participants With Treatment-Emergent Adverse Events (TEAEs) |
240; 265; 270; 20; 14; 15 | — |
| SECONDARY Change From Baseline in the Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug |
-3.2; -4.9; -5.0 | <0.0001 sig |
| SECONDARY Percentage of Participants With At Least 50% Reduction In Monthly Average Number of Headache Days of At Least Moderate Severity |
21.6; 41.3; 40.0; 24.3; 39.7; 41.9 | <0.0001 sig |
| SECONDARY Change From Baseline in the Monthly Average Number of Days of Use of Any Acute Headache Medicine During the 12 Week Period After the First Dose of Study Drug |
-2.0; -3.6; -4.2 | <0.0001 sig |
| SECONDARY Change From Baseline in the Number of Headache Days of At Least Moderate Severity During the 4 Week Period After the First Dose of Study Drug |
-2.3; -4.6 | <0.0001 sig |
| SECONDARY Change From Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity During the 12 Week Period After the First Dose of Study Medication in Patients Not Receiving Concomitant Preventive Migraine Medications |
-2.4; -4.4; -4.6 | <0.0001 sig |
| SECONDARY Change From Baseline in Migraine-Related Disability Score, As Measured by the 6-Item Headache Impact Test (HIT) At Week 12 |
-4.0; -5.0; -6.0 | 0.0004 sig |
| SECONDARY Electrocardiogram (ECG) Findings Shifts From Baseline to Overall |
215; 220; 223; 54; 48; 43 | — |
| SECONDARY Participants With Vital Signs Potentially Clinically Significant Abnormal Values |
7; 10; 14; 0; 0; 1 | — |
| SECONDARY Participants With Serum Chemistry and Hematology Potentially Clinically Significant Abnormal Results |
1; 1; 1; 2; 0; 0 | — |
| SECONDARY Participants With Urinalysis Laboratory Tests Potentially Clinically Significant Abnormal Results |
78; 57; 68; 33; 32; 35 | — |
| SECONDARY Prothrombin Time Shifts From Baseline to Endpoint |
0; 0; 0; 2; 0; 1 | — |
| SECONDARY Injection Site Reaction Adverse Events |
151; 176; 183; 104; 114; 99 | — |
| SECONDARY Participants With Positive Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) Results After the First Dose of Study Drug |
1; 1; 1; 1; 1; 0 | — |
Summary
The study is being conducted to evaluate two doses of TEV-48125 in adult patients with chronic migraine
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02621931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.