Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-04 @ 6:42 PM
Study NCT ID:
NCT03303105
Status:
COMPLETED
Last Update Posted:
2023-02-17
First Post:
2017-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine
Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| JapicCTI-173726 | OTHER | Japic | View |