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Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine

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ClinicalTrials.gov Identifier: NCT02621931
Recruitment Status : Completed
First Posted : December 4, 2015
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The study is being conducted to evaluate two doses of TEV-48125 in adult patients with chronic migraine

Condition or disease Intervention/treatment Phase
Migraine Drug: TEV-48125 - 1 Drug: TEV-48125 - 2 Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1134 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 Study Comparing the Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine
Actual Study Start Date : January 31, 2016
Primary Completion Date : April 7, 2017
Study Completion Date : April 7, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: TEV-48125 - 1
Dose Regimen 1
Drug: TEV-48125 - 1
Subcutaneous administration Dose Regimen 1
Other Name: monoclonal antibody
Experimental: TEV-48125 - 2
Dose Regimen 2
Drug: TEV-48125 - 2
Subcutaneous administration Dose Regimen 2
Other Name: monoclonal antibody
Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo
Matching Placebo


Outcome Measures

Primary Outcome Measures :
  1. Mean change from baseline in the monthly average number of headache days of at least moderate severity [ Time Frame: Baseline, 12 weeks ]
  2. Percentage of participants with adverse events [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Proportion of patients reaching at least 50% reduction in the monthly average number of headache days of at least moderate severity [ Time Frame: 12 weeks ]
  2. Mean change from baseline in the monthly average number of days of use of any acute headache medications [ Time Frame: Baseline, 12 weeks ]
  3. Mean change from baseline in the number of headache days of at least moderate severity [ Time Frame: Baseline, 4 weeks ]
  4. Mean change from baseline in disability score, as measured by 6 item questionnaire (HIT-6) [ Time Frame: Baseline, 4 weeks ]
    HIT-6 questionnaire contains 6 qualitative questions with answers ranging from never to always

  5. Mean change from baseline in the monthly average number of migraine days during the 12-week period after the 1st dose of study drug [ Time Frame: Baseline, 12 weeks ]

Eligibility Criteria

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:

  • Males or females aged 18 to 70 years, inclusive, 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
  • Total body weight between 99 and 250 lbs, inclusive

    • Additional criteria apply, please contact the investigator for more information

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 prior to study drug administration or 5 half-lives, whichever is longer

    • 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): NCT02621931


  Show 137 Study Locations
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Teva Medical Expert, MD TEVA
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT02621931     History of Changes
Other Study ID Numbers: TV48125-CNS-30049
2015-004549-23 ( EudraCT Number )
First Posted: December 4, 2015    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 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
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs