- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03303105
Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine
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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Iruma, Japan
- Saitama Medical University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 or Episodic 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 2 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:
- Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: TEV-48125 (225 mg/1 month) group
TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses (at 225 mg once monthly [except for a loading dose of 675 mg in subjects with CM]).
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TEV-48125 will be administered subcutaneously once every 4 weeks.
TEV-48125 will be administered subcutaneously once every 12 weeks.
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Experimental: TEV-48125 (675 mg/3 month) group
TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).
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TEV-48125 will be administered subcutaneously once every 4 weeks.
TEV-48125 will be administered subcutaneously once every 12 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Subjects With at Least One Treatment-Emergent Adverse Event (TEAE)
Time Frame: Baseline (Day 0) up to follow-up visit (Day 562)
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Baseline (Day 0) up to follow-up visit (Day 562)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in the Monthly (28 Day) Average Number of Migraine Days
Time Frame: Baseline, Month 12
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Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as mild, moderate, or severe. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications. |
Baseline, Month 12
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Mean Change From Baseline in the Monthly (28 Day) Average Number of Headache Days of at Least Moderate Severity
Time Frame: Baseline, Month 12
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Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as mild, moderate, or severe. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications. |
Baseline, Month 12
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 406-102-00003
- JapicCTI-173726 (Other Identifier: Japic)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Migraine
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Austrian Migraine Registry CollaborationMedical University of Vienna; Medical University Innsbruck; Austrian Headache...RecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineAustria
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Tonix Pharmaceuticals, Inc.PremierCompletedChronic Migraine | Chronic Migraine, Headache | Chronic Migraine Without Aura | Aura MigraineUnited States
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Harvard University Faculty of MedicineBrigham and Women's Hospital; Palmer Center for Chiropractic Research (PCCR)CompletedMigraine | Migraine Disorders | Migraine Without Aura | Migraine With Aura | Migraine, ClassicUnited States
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University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
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CoolTech LLCTerminatedMigraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineUnited States
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University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
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Notre-Dame Hospital, Montreal, Quebec, CanadaAllerganCompletedChronic Migraine | Migraine Without Aura | Migraine With AuraCanada
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Glostrup University Hospital, CopenhagenUnknownChronic Migraine | Migraine Without Aura | Migraine With AuraDenmark
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo...CompletedMigraine With Aura | Migraine in ChildrenItaly
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The Cleveland ClinicWithdrawnMigraine | Migraine Disorders | Headache Disorders, Primary | Migraine Headache | Migraine Without Aura | Migraine With Aura | Headache, MigraineUnited States
Clinical Trials on TEV-48125
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Teva Branded Pharmaceutical Products R&D, Inc.TerminatedCluster HeadacheUnited States, Australia, Canada, Finland, Germany, Israel, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom
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Teva Branded Pharmaceutical Products R&D, Inc.TerminatedChronic Cluster HeadacheUnited States, Australia, Canada, Finland, Germany, Israel, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom
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Teva Branded Pharmaceutical Products R&D, Inc.CompletedMigraineUnited States, Canada, Czechia, Finland, Israel, Japan, Poland, Russian Federation, Spain
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Teva Branded Pharmaceutical Products R&D, Inc.CompletedPost-Traumatic HeadacheUnited States
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Teva Branded Pharmaceutical Products R&D, Inc.TerminatedEpisodic Cluster HeadacheUnited States, Australia, Finland, Germany, Israel, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom, Canada
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Teva Branded Pharmaceutical Products R&D, Inc.CompletedMigraine ProphylaxisUnited States, Belgium, Czechia, Denmark, Finland, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom
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Teva Branded Pharmaceutical Products R&D, Inc.Completed
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Otsuka Pharmaceutical Co., Ltd.Completed
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Otsuka Pharmaceutical Co., Ltd.Completed
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Teva Branded Pharmaceutical Products R&D, Inc.CompletedMigraine | Major Depressive DisorderUnited States, Czechia, Finland, Israel, Italy, Russian Federation, Spain, Ukraine, France, Germany, Greece, Poland, United Kingdom