Phase 3
Completed N=71
A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients
Source: ClinicalTrials.gov NCT04355117 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) — 18; 26 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This trial assesses the safety of TEV-48125 when subcutaneously self-administered in Japanese migraine patients using an autoinjector (AI) at home. Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses. The first dose will be self-administered at the trial site under the supervision of the investigator and the second dose will be self-administered at home.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) |
18; 26 | — |
| SECONDARY Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI |
71; 70; 0; 1; 0; 0 | — |
| SECONDARY Execution Status of Self-administration - Leakage of Drug Solution on the Skin |
58; 48; 12; 20; 1; 3 | — |
| SECONDARY Subject Compliance With the Self-administration Procedure |
71; 70; 0; 1 | — |
| SECONDARY Number of Deficiencies With the AI Device |
1 | — |
Eligibility Criteria
Inclusion Criteria
- Patient has a history of migraine (according to the ICHD-3 criteria) diagnosis for ≥12 months prior to giving informed consent.
- Patient fulfills any of the migraine criteria(according to the ICHD-3 criteria) on ≥4 days in baseline information collected during the 28-day screening period
Exclusion Criteria
- History of hypersensitivity reactions to injected proteins, including monoclonal antibodies
- Prior exposure to a monoclonal antibody targeting (CGRP) pathway meeting the following conditions:
- Less than 5 months has passed since the final administration of AMG334, ALD304, or LY2951742.
- Less than 1 year has passed since the final administration of TEV-48125
Data sourced from ClinicalTrials.gov (NCT04355117). 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.