A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients

Otsuka

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: 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.

Study type: Interventional

Funder types: Industry

Identifiers

NCT04355117

406-102-00005

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

Treatment: TEV-48125

Experimental group

Treatment:

Drug: 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.