We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Efficacy and Safety Study of Fremanezumab in Adults With Migraine (FOCUS)

This study is not yet open for participant recruitment.
Verified October 2017 by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
Sponsor:
ClinicalTrials.gov Identifier:
NCT03308968
First Posted: October 13, 2017
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
  Purpose

The purpose of this study is to evaluate the efficacy, safety, and tolerability of monthly and quarterly subcutaneous (sc) injections of fremanezumab compared with sc injections of placebo in patients with chronic migraine (CM) or episodic migraine (EM) who have responded inadequately to 2 to 4 classes of prior preventive treatments.

Approximately equal numbers of patients from each subgroup (CM and EM) are randomized in blinded-fashion 1:1:1 into one of three treatments for the subgroup - two active treatments and one placebo treatment --- consisting of monthly injections for 3 months (up to week 12). Then all participants continue into an open-label extension of 3 months (weeks 13-week 24) during which everyone is administered sc injections of fremanezumab.


Condition Intervention Phase
Migraine Prophylaxis Drug: Fremanezumab Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ):

Primary Outcome Measures:
  • mean change from baseline in the monthly average number of migraine days during the double-blind period [ Time Frame: Baseline (days -28 to 0), Treatment up to week 12 ]

Secondary Outcome Measures:
  • proportion of patients reaching at least 50% reduction in the monthly average number of migraine days during the double-blind period [ Time Frame: Baseline, 12 weeks ]
  • mean change from baseline in the monthly average number of headache days of at least moderate severity during the double-blind period [ Time Frame: Baseline, 12 weeks ]
  • mean change from baseline in the monthly average number of migraine days during the double-blind period [ Time Frame: Baseline, 4 weeks ]
  • proportion of patients reaching at least 50% reduction in the monthly average number of migraine days during the double-blind period [ Time Frame: 4 weeks ]
  • mean change from baseline in the monthly average number of days of use of any acute headache medications during the double-blind period [ Time Frame: Baseline, 12 weeks ]
  • mean change from baseline in the number of headache days of at least moderate severity during the double-blind period [ Time Frame: Baseline, 4 weeks ]
  • percentage of patients who did not complete study due to AEs [ Time Frame: 12 weeks ]
  • Percentage of Participants with Adverse Events [ Time Frame: 12 weeks ]

Estimated Enrollment: 804
Anticipated Study Start Date: October 12, 2017
Estimated Study Completion Date: August 22, 2019
Estimated Primary Completion Date: August 22, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fremanezumab Monthly
During the double-blind period, participants with chronic migraine (CM) are administered Dosage A subcutaneous (sc) injection of fremanezumab at Week 0 (baseline) followed by Dosage B sc injections at Week 4 and Week 8 and participants with episodic migraine (EM) are administered Dosage B subcutaneous (sc) injection of fremanezumab at Week 0 (baseline), Week 4, and Week 8 then followed by an open label period where all participants are administered Dosage B sc injection of fremanezumab at Weeks 12, 16 and 20.
Drug: Fremanezumab
Prefilled syringes contain Dosage B total of active ingredient fremanezumab administered by subcutaneous injection. Week 0 doses of Dosage A consisted of three injections. Week 0 doses of Dosage B consisted of one injection.
Other Name: TEV-48125
Experimental: Fremanezumab Quarterly
During the double-blind period, participants with chronic migraine (CM) and participants with episodic migraine (EM) are administered Dosage A sc injection of fremanezumab at Week 0 (baseline) followed by placebo sc injections at Week 4 and Week 8 followed by an open label period where all participants are administered Dosage B sc injection of fremanezumab at Weeks 12, 16 and 20.
Drug: Fremanezumab
Prefilled syringes contain Dosage B total of active ingredient fremanezumab administered by subcutaneous injection. Week 0 doses of Dosage A consisted of three injections. Week 0 doses of Dosage B consisted of one injection.
Other Name: TEV-48125
Drug: Placebo
Prefilled syringes contain the same vehicle as the active intervention administered by subcutaneous injection. Week 0 doses of Dosage B consisted of two injections of placebo to maintain the blind. Week 0 doses of placebo consisted of three injections of placebo to maintain the blind.
Placebo Comparator: Placebo
During the double-blind period, participants with chronic migraine (CM) and participants with episodic migraine (EM) are administered 3 placebo sc injections at Week 0, and 1 placebo injection at weeks 4 and 8 followed by an open label period where all participants are administered Dosage B sc injection of fremanezumab at Weeks 12, 16 and 20.
Drug: Fremanezumab
Prefilled syringes contain Dosage B total of active ingredient fremanezumab administered by subcutaneous injection. Week 0 doses of Dosage A consisted of three injections. Week 0 doses of Dosage B consisted of one injection.
Other Name: TEV-48125
Drug: Placebo
Prefilled syringes contain the same vehicle as the active intervention administered by subcutaneous injection. Week 0 doses of Dosage B consisted of two injections of placebo to maintain the blind. Week 0 doses of placebo consisted of three injections of placebo to maintain the blind.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has a diagnosis of migraine with onset at ≤50 years of age.
  • Body weight ≥45 kg
  • The patient has a history of migraine for ≥12 months prior to screening.
  • Women of childbearing potential (WOCBP) whose male partners are potentially fertile (ie, 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 [eg, 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, patient is receiving any preventive migraine medications, regardless of the medical indication for more than 5 days and expects to continue with these medications.
  • Patient 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 patient has used an intervention/device (eg, scheduled nerve blocks and transcranial magnetic stimulation) for migraine during the 2 months prior to screening.
  • The patient uses triptans/ergots as preventive therapies for migraine.
  • Patient uses non-steroidal anti-inflammatory drugs (NSAIDs) as preventive therapy for migraine on nearly daily basis for other indications. Note: Low dose aspirin (eg, 81 mg) used for cardiovascular disease prevention is allowed.

    • Additional criteria apply, please contact the investigator for more information
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308968


  Show 126 Study Locations
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Teva Medical Expert, MD TEVA
  More Information

Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT03308968     History of Changes
Other Study ID Numbers: TV48125-CNS-30068
2017-002441-30 ( EudraCT Number )
First Submitted: October 3, 2017
First Posted: October 13, 2017
Last Update Posted: October 13, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases