An Efficacy and Safety Study of Fremanezumab in Adults With Migraine

• Register: ClinicalTrials.gov
• Last refreshed on: 15 November 2021
• Main ID: NCT03308968
• Date of registration: 03/10/2017
• Prospective Registration: Yes
• Primary sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Public title: An Efficacy and Safety Study of Fremanezumab in Adults With Migraine FOCUS
• Scientific title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study With an Open-Label Period to Evaluate the Efficacy and Safety of Fremanezumab for the Prophylactic Treatment of Migraine in Patients With Inadequate Response to Prior Preventive Treatments
• Date of first enrolment: October 13, 2017
• Target sample size: 838
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03308968
• 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

Belgium, Czechia, Denmark, Finland, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- The participant has a diagnosis of migraine with onset at =50 years of age.

- Body weight =45 kilograms.

- The participant has a history of migraine for =12 months prior to screening.

- Women of childbearing potential (WOCBP) whose male partners are potentially fertile
(that is; no vasectomy) must use highly effective birth control methods for the
duration of the study and the follow-up period and for 6.0 months after
discontinuation of investigational medicinal product (IMP)

- Men must be sterile, or if they are potentially fertile/reproductively competent (not
surgically [that is; vasectomy] or congenitally sterile) and their female partners are
of childbearing potential, must use, together with their female partners, acceptable
birth control methods for the duration of the study and for 6.0 months after
discontinuation of the investigational medicinal product (IMP).

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

Exclusion Criteria:

- At the time of screening visit, participant is receiving any preventive migraine
medications, regardless of the medical indication for more than 5 days and expects to
continue with these medications.

- Participant has received onabotulinumtoxinA for migraine or for any medical or
cosmetic reasons requiring injections in the head, face, or neck during the 3 months
before screening visit.

- The participant has used an intervention/device (for example; scheduled nerve blocks
and transcranial magnetic stimulation) for migraine during the 2 months prior to
screening.

- The participant uses triptans/ergots as preventive therapies for migraine.

- Participant uses non-steroidal anti-inflammatory drugs (NSAIDs) as preventive therapy
for migraine on nearly daily basis for other indications. Note: Low dose aspirin (for
example; 81 mg) used for cardiovascular disease prevention is allowed.

- 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 Prophylaxis

Intervention(s)

Drug: Fremanezumab

Drug: Placebo

Primary Outcome(s)

DB Period: Change From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Fremanezumab [Time Frame: Baseline (Day -28 to Day -1), up to Week 12]

Secondary Outcome(s)

DB Period: Number of Participants With Adverse Events (AEs) and Who Did Not Complete the Study Due to AEs [Time Frame: Baseline (Day 0) up to Week 12]

DB Period: Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests Results [Time Frame: Baseline up to Week 12]

DB Period: Number of Participants With Shift From Baseline to Week 12 in Electrocardiogram (ECG) Parameters [Time Frame: Baseline, Week 12]

DB Period: Number of Participants With Potentially Clinically Significant Abnormal Coagulation Laboratory Test Results [Time Frame: Baseline up to Week 12]

DB Period: Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 4-Week Period After the First Dose of Fremanezumab [Time Frame: Baseline (Day -28 to Day -1), up to Week 4]

DB Period: Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values [Time Frame: Baseline up to Week 12]

DB Period: Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 12-Week Period After the First Dose of Fremanezumab [Time Frame: Baseline (Day -28 to Day -1), up to Week 12]

DB Period: Change From Baseline in Monthly Average Number of Days of Use of Any Acute Headache Medications During the 12-Week Period After the First Dose of Fremanezumab [Time Frame: Baseline (Day -28 to Day -1), up to Week 12]

OL Period: Number of Participants With AEs and Who Did Not Complete the Study Due to AEs [Time Frame: Week 12 up to Week 24]

DB Period: Number of Participants Who Received Concomitant Medications for Adverse Events [Time Frame: Baseline up to Week 12]

OL Period: Number of Participants With Potentially Clinically Significant Abnormal Coagulation Laboratory Test Results [Time Frame: Week 12 up to Week 24]

DB Period: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results [Time Frame: Baseline up to Week 12]

OL Period: Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests Results [Time Frame: Week 12 up to Week 24]

DB Period: Change From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period After the First Dose of Fremanezumab [Time Frame: Baseline (Day -28 to Day -1), up to Week 4]

DB Period: Number of Participants With Potentially Clinically Significant Abnormal Hematology Results [Time Frame: Baseline up to Week 12]

OL Period: Number of Participants Who Received Concomitant Medications for Adverse Events [Time Frame: Week 12 up to Week 24]

OL Period: Number of Participants With Potentially Clinically Significant Abnormal Hematology Results [Time Frame: Week 12 up to Week 24]

OL Period: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results [Time Frame: Week 12 up to Week 24]

OL Period: Number of Participants With Shift From Baseline to Week 24 in ECG Parameters [Time Frame: Baseline, Week 24]

DB Period: Percentage of Participants Reaching at Least 50 Percent (%) Reduction From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Fremanezumab [Time Frame: Baseline (Day -28 to Day-1), up to Week 12]

DB Period: Percentage of Participants Reaching at Least 50% Reduction From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period After the First Dose of Fremanezumab [Time Frame: Baseline (Day -28 to Day-1), up to Week 4]

OL Period: Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values [Time Frame: Week 12 up to Week 24]

Secondary ID(s)

2017-002441-30

TV48125-CNS-30068

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/10/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03308968