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

Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Episodic Migraine

This study is currently recruiting participants.
Verified October 2017 by Otsuka Pharmaceutical Co., Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03303092
First Posted: October 5, 2017
Last Update Posted: October 5, 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):
Otsuka Pharmaceutical Co., Ltd.
  Purpose
To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 (monthly TEV-48125 225 mg and TEV-48125 675 mg once over a period of 3 months) compared with placebo for preventive treatment in Episodic Migraine patients

Condition Intervention Phase
Migraine Drug: TEV-48125 Drug: Placebos Phase 2 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, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Episodic Migraine

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Mean change from baseline in the monthly (28-day) average number of migraine days during the 12-week period after the first dose of Interventional Medicinal Product [ Time Frame: Baseline, 12 weeks ]

Secondary Outcome Measures:
  • Proportion of patients reaching at least 50% reduction in the monthly average number of migraine days [ Time Frame: 12 weeks ]
  • Mean change from baseline in the monthly average number of days of use of any acute migraine medications relative to baseline [ Time Frame: Baseline, 12 weeks ]
  • Mean change from baseline in the number of migraine days [ Time Frame: Baseline, 4 weeks ]

Estimated Enrollment: 330
Anticipated Study Start Date: November 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TEV-48125 (225/225/225 mg) group
TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).
Drug: TEV-48125
TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months.
Experimental: TEV-48125 (675 mg/placebo/placebo) group
TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).
Drug: TEV-48125
TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months.
Placebo Comparator: Placebo group
Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).
Drug: Placebos
Placebo will be subcutaneously administered once monthly for 3 months.

  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:

  • Patients 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

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
  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): NCT03303092


Contacts
Contact: Drug Information Center +81-3-6361-7366

Locations
Japan
Recruiting
Kanoto Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Hiroaki Ono Otsuka Pharmaceutical Co., Ltd.
  More Information

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03303092     History of Changes
Other Study ID Numbers: 406-102-00002
First Submitted: October 2, 2017
First Posted: October 5, 2017
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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