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Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine

This study is currently recruiting participants.
Verified October 2017 by Otsuka Pharmaceutical Co., Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03303105
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 long-term safety and tolerability of subcutaneous (SC) administration of TEV-48125 (at 225 mg once monthly [except for a loading dose of 675 mg for CM patients] or at 675 mg every 3 months) for the preventive treatment of Chronic Migraine and Episodic Migraine patients

Condition Intervention Phase
Migraine Drug: TEV-48125 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-label Trial Evaluating the Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of Participants with Adverse Events [ Time Frame: Day562 ]

Secondary Outcome Measures:
  • Mean change from baseline in the number of migraine days [ Time Frame: Day337 ]
  • Mean change from baseline in the monthly average of migraine days [ Time Frame: Day337 ]
  • Mean change from baseline in the number of headache days of any severity [ Time Frame: Day337 ]
  • Mean change from baseline in the monthly average of headache days of any severity [ Time Frame: Day337 ]

Estimated Enrollment: 40
Anticipated Study Start Date: November 2018
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TEV-48125 (225 mg/1 month) group
TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses to subjects of 225 mg/1 month group.
Drug: TEV-48125
TEV-48125 will be administered subcutaneously once every 4 weeks or 12 weeks.
Experimental: TEV-48125 (675 mg/3 month) group
TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses to subjects of 675 mg/3 months group.
Drug: TEV-48125
TEV-48125 will be administered subcutaneously once every 4 weeks or 12 weeks.

  Eligibility

Information from the National Library of Medicine

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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 or clinical judgment suggests a migraine diagnosis
  • Patient fulfills the criteria for episodic migraine (EM) or chronic migraine (CM)
  • All patients must be of nonchildbearing potential

    ・ Patients must simultaneously use 2 forms of highly effective contraception methods

    • Patients will remain abstinent throughout the study
    • Patients have sexual preference that precludes the possibility of pregnancy.
  • Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-HCG) pregnancy test prior to randomization (confirmed by urine dipstick at baseline).
  • The patient 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 as specified in this protocol.

Exclusion Criteria:

  • 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
  • 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
  • Any finding considered clinically significant in the judgment of the investigator
  • History of alcohol or drug abuse during the past 2 years, or alcohol or drug dependence during the past 5 years
  • The patient cannot participate or successfully complete the study, in the opinion of their healthcare provider or the investigator, for any of the following reasons:

    ・ mentally or legally incapacitated or unable to give consent for any reason

    • in custody due to an administrative or a legal decision, under tutelage, or being admitted to a sanitarium or social institution
    • unable to be contacted in case of emergency
    • has any other condition, which, in the opinion of the investigator, makes the patient inappropriate for inclusion in the study
  • Patient is a study center or sponsor employee who is directly involved in the study or the relative of such an employee.
  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): NCT03303105


Contacts
Contact: Drug Information Center +81-3-6361-7314

Locations
Japan
Recruiting
Knanto 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: NCT03303105     History of Changes
Other Study ID Numbers: 406-102-00003
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