Phase 3
Completed N=50
Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine
Source: ClinicalTrials.gov NCT03303105 ↗Enrolled (actual)
50
Serious AEs
4.0%
Results posted
Jul 2021
Primary outcomePrimary: Percentage of Subjects With at Least One Treatment-Emergent Adverse Event (TEAE) — 92.0; 88.0 percentage of participants
◆ Published Evidence
Emerging
19citations · ~4 / year
Long-Term Safety and Tolerability of Fremanezumab for Migraine Preventive Treatment in Japanese Outpatients: A Multicenter, Randomized, Open-Label Study.
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
Linked Publications
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Long-Term Safety and Tolerability of Fremanezumab for Migraine Preventive Treatment in Japanese Outpatients: A Multicenter, Randomized, Open-Label Study.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.