Phase 3
Completed N=875
Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine
Source: ClinicalTrials.gov NCT02629861 ↗Enrolled (actual)
875
Serious AEs
1.5%
Results posted
Nov 2018
Primary outcomePrimary: Change From Baseline in the Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug — -2.7; -4.0; -4.2 days — p=<0.0001
◆ Published Evidence
Established
29citations · ~6 / year
Efficacy and safety of fremanezumab in clinical trial participants aged ≥60 years with episodic or chronic migraine: pooled results from 3 randomized, double-blind, placebo-controlled phase 3 studies.
Summary
The study is being conducted to evaluate two doses of TEV-48125 in adult patients with episodic migraine
Linked Publications (5)
-
Efficacy and safety of fremanezumab in clinical trial participants aged ≥60 years with episodic or chronic migraine: pooled results from 3 randomized, double-blind, placebo-controlled phase 3 studies.
-
Safety and tolerability of fremanezumab in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies.
-
Treatment benefit among migraine patients taking fremanezumab: results from a post hoc responder analysis of two placebo-controlled trials.
-
Impact of fremanezumab on disability outcomes in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies.
-
Effects of fremanezumab on migraine-associated symptoms and medication use in Japanese and Korean patients with episodic migraine: Exploratory endpoint analysis of a multicenter, randomized, double-blind, placebo-controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug |
-2.7; -4.0; -4.2 | <0.0001 sig |
| PRIMARY Participants With Adverse Events |
171; 193; 192; 11; 16; 10 | — |
| SECONDARY Percentage of Participants With At Least 50% Reduction In Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug |
25.2; 44.1; 47.0; 34.8; 46.9; 48.4 | <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 |
-1.7; -3.0; -3.2 | <0.0001 sig |
| SECONDARY Change From Baseline in the Number of Migraine Days During the 4 Week Period After the First Dose of Study Drug |
-2.0; -4.0; -4.0 | <0.0001 sig |
| SECONDARY Change From Baseline in the Monthly Average Number of Migraine Days During the 12 Week Period After the First Dose of Study Medication in Patients Not Receiving Concomitant Preventive Migraine Medications |
-2.9; -4.0; -4.2 | <0.0001 sig |
| SECONDARY Change From Baseline in Migraine-Related Disability Score (MIDAS), As Measured by the Migraine Disability Assessment At 4 Weeks After the Last (3rd) Dose of Study Drug |
-12.5; -18.0; -19.0 | 0.0023 sig |
| SECONDARY Electrocardiogram Finding Shifts From Baseline to Overall |
161; 169; 181; 32; 41; 25 | — |
| SECONDARY Participants With Vital Signs Potentially Clinically Significant Abnormal Values |
3; 4; 5; 0; 1; 0 | — |
| SECONDARY Participants With Serum Chemistry and Hematology Potentially Clinically Significant Abnormal Results |
1; 0; 1; 1; 0; 1 | — |
| SECONDARY Participants With Urinalysis Laboratory Tests Potentially Clinically Significant Abnormal Results |
55; 54; 49; 29; 30; 23 | — |
| SECONDARY Prothrombin Time Shifts From Baseline to Endpoint |
0; 0; 0; 0; 1; 1 | — |
| SECONDARY Injection Site Reaction Adverse Events |
106; 131; 130; 76; 86; 87 | — |
| SECONDARY Participants With Positive Electronic Columbia Suicide Severity Rating Scale Results After the First Dose of Study Drug |
0; 0; 2; 0; 0; 0 | — |
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 265 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 or 5 half-lives, whichever is longer
- Additional criteria apply, please contact the investigator for more information
Data sourced from ClinicalTrials.gov (NCT02629861) and the linked publication. 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. Informational only — not medical advice.