Efficacy and Safety of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine

• Register: ClinicalTrials.gov
• Last refreshed on: 15 November 2021
• Main ID: NCT02638103
• Date of registration: 18/12/2015
• Prospective Registration: Yes
• Primary sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Public title: Efficacy and Safety of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine HALO
• Scientific title: A Multicenter, Randomized, Double-Blind, Parallel-Group Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine
• Date of first enrolment: February 26, 2016
• Target sample size: 1890
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02638103
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Canada, Czech Republic, Czechia, Denmark, Finland, Germany, Hungary, Israel, Italy, Japan, Poland, Russian Federation, Spain, Ukraine, United States

Contacts

• Name: Teva Medical Expert, MD
• Affiliation: Teva Branded Pharmaceutical Products R&D, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

Participants Rolling Over from the Pivotal Efficacy Studies:

- Participant must have signed and dated the informed consent document.

- Participant must have completed the pivotal efficacy study without major protocol
violations.

- Additional criteria apply, please contact the investigator for more information.

Participants Not Rolling Over from the Pivotal Efficacy Studies:

- Males or females aged 18 to 70 years, inclusive, with migraine onset at less than or
equal to (=) 50 years of age.

- Participant signed and dated the informed consent document.

- Participant has a history of migraine or clinical judgment suggests a migraine
diagnosis.

- Participant fulfills the criteria for EM or CM with prospectively collected baseline
information during the 28-day run-in period.

- Body mass index (BMI) of 17.5 to 37.5 kilograms/square meter (kg/m^2) and a total body
weight between 45 and 120 kg, inclusive.

- All participants must be of non-childbearing potential.

1. Participants must simultaneously use 2 forms of highly effective contraception
methods.

2. Participants will remain abstinent throughout the study.

- Female participants of childbearing potential must have a negative serum beta-human
chorionic gonadotropin (ß-HCG) pregnancy test prior at screening (confirmed by urine
dipstick ß-HCG pregnancy test at baseline).

- The participant must be willing and able to comply with study restrictions, to remain
at the clinic for the required duration during the study period, and to return to the
clinic for the follow-up evaluation.

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

Exclusion Criteria:

Participants Rolling Over from the Pivotal Efficacy Studies:

- Pregnant or nursing females

- Compliance with daily diary entry lower than 75 percent (%) at the last month of the
double-blind treatment period of the pivotal efficacy study.

- Additional criteria apply, please contact the investigator for more information.

Participants Not Rolling Over from the Pivotal Efficacy Studies:

- Clinically significant findings 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 [for example; 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 past 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 before study drug administration or 5 half-lives, whichever is longer.

- History of alcohol or drug abuse during the past 2 years, or alcohol or drug
dependence during the past 5 years.

- The participant cannot participate or successfully complete the study, in the opinion
of their healthcare provider or the investigator, for any of the following reasons:

1. mentally or legally incapacitated or unable to give consent for any reason.

2. in custody due to an administrative or a legal decision, under guardianship, or
institutionalized.

3. unable to be contacted in case of emergency.

4. has any other condition, which, in the opinion of the investigator, makes the
participant inappropriate for inclusion in the study.

- Participant is a study center or sponsor employee who is directly involved in the
study or the relative of such an employee.

- Additional criteria apply, please contact the investigator for more information.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Migraine

Intervention(s)

Drug: Fremanezumab

Drug: Placebo

Primary Outcome(s)

Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests Results [Time Frame: Baseline (Day 0) up to EOT visit (Day 336)]

Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values [Time Frame: Baseline (Day 0) up to EOT visit (Day 336)]

Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) [Time Frame: Baseline (Day -28 to Day -1), Month 12]

Number of Participants With Adverse Events (AEs) [Time Frame: Baseline (Day 0) up to follow-up visit (Day 533)]

Number of Participants With Potentially Clinically Significant Abnormal Hematology Results [Time Frame: Baseline (Day 0) up to EOT visit (Day 336)]

Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters [Time Frame: Baseline (Day 0), endpoint (Day 336)]

Number of Participants With Injection Site Reactions [Time Frame: Baseline (Day -28 to Day -1), Month 12]

Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results [Time Frame: Baseline (Day 0), endpoint (Day 336)]

Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results [Time Frame: Baseline (Day 0) up to end of treatment (EOT) visit (Day 336)]

Secondary ID(s)

TV48125-CNS-30051

2015-004550-18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/08/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02638103