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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03303079
Recruitment Status : Completed
First Posted : October 5, 2017
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 [monthly TEV-48125 225 mg (loading dose only: 675 mg) and TEV-48125 675 mg once over a period of 3 months] compared with placebo for preventive treatment in Chronic Migraine patients

Condition or disease Intervention/treatment Phase
Migraine Drug: TEV-48125 Drug: TEV-48125 or placebo Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 571 participants
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 Chronic Migraine
Actual Study Start Date : December 19, 2017
Actual Primary Completion Date : November 30, 2019
Actual Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: TEV-48125 (675/225/225 mg) group
TEV-48125 will be subcutaneously administered once monthly for 3 months (675/225/225 mg).
Drug: TEV-48125
TEV-48125 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 or placebo
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: Placebo
Placebo will be subcutaneously administered once monthly for 3 months.




Primary Outcome Measures :
  1. Mean change from baseline in the monthly (28 day) average number of headache days of at least moderate severity during the 12-week period after the first dose of Investigational Medicinal Product(IMP) [ Time Frame: Baseline, 12 weeks ]

Secondary Outcome Measures :
  1. Mean change from baseline in the monthly average number of migraine days during the 12-week period after the first dose of IMP [ Time Frame: Baseline, 12 weeks ]
  2. Proportion of subjects reaching at least 50% reduction in the monthly average number of headache days of at least moderate severity during the 12-week period after the first dose of IMP [ Time Frame: 12 weeks ]
  3. Mean change from baseline in the monthly average number of days with use of any acute headache medications during the 12-week period after the first dose of IMP [ Time Frame: Baseline, 12 weeks ]
  4. Mean change from baseline in the monthly average number of headache days of at least moderate severity during the 12-week period after the first dose of IMP in subjects not receiving concomitant preventive migraine medications [ Time Frame: Baseline, 12 weeks ]
  5. Mean change from baseline in disability score, as measured by the HIT-6, at 4 weeks after the final (third) dose of IMP [ Time Frame: Baseline, 4 weeks ]


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

Inclusion Criteria:

  • Patient has a history of migraine (according to The International Classification of Headache Disorders, third edition [beta version] criteria) or clinical judgment suggests a migraine diagnosis
  • Patient fulfills the criteria for Chronic migraine in baseline information collected during the 28 day screening period
  • Not using preventive migraine medications for migraine or other medical conditions or using no more than 1 preventive migraine medication for migraine or other medical conditions if the dose and regimen have been stable for at least 2 months prior to giving informed consent.
  • Patient demonstrates compliance with the electronic headache diary during the screening period by entry of headache data on a minimum of 24 of 28 days and the entered data is judged appropriate by the investigator.

Exclusion Criteria:

  • Patients who have previously failed (lack of efficacy) 2 or more of the clusters of the medications for treatment of migraine after use for at least 3 months at accepted migraine therapeutic doses
  • Patient suffers from unremitting headaches, defined as having headaches for more than 80% of the time that he/she is awake, and less than 4 days without headache per month. Daily headache is acceptable if the patient has headaches 80% or less of the time they are awake on most days.
  • Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator

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): NCT03303079


Locations
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Japan
Saitama Medical University Hospital
Iruma, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Takehisa Matsumaru Otsuka Pharmaceutical Co., Ltd.
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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03303079    
Other Study ID Numbers: 406-102-00001
JapicCTI-173723 ( Other Identifier: Japic )
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs