Phase 3
N=50
Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT03303105 ↗Enrolled (actual)
50
Serious AEs
4.0%
Results posted
Jul 2021
Primary outcome: Primary: Percentage of Subjects With at Least One Treatment-Emergent Adverse Event (TEAE) — 92.0; 88.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- TEV-48125 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With at Least One Treatment-Emergent Adverse Event (TEAE) |
92.0; 88.0 | — |
| SECONDARY Mean Change From Baseline in the Monthly (28 Day) Average Number of Migraine Days |
-5.9; -1.6 | — |
| SECONDARY Mean Change From Baseline in the Monthly (28 Day) Average Number of Headache Days of at Least Moderate Severity |
-4.3; -2.1 | — |
Summary
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
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT03303105). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.