Fremanezumab Compassionate Use Program for Pediatric Patients
- Conditions
- Migraine
- Registration Number
- NCT03539393
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
This is a Compassionate Use Program (CUP) based on a licensed physician's unsolicited request. Specifically, this CUP is for male and female pediatric patients 6 to 17 years with a diagnosis of either episodic or chronic migraine who have successfully completed the Teva sponsored study TV48125-CNS-30084 (SPACE study).
- Detailed Description
Patients must have successfully completed the clinical trial according to the 30084 protocol, without any major protocol violations or tolerability issues, or who are anticipated to complete this trial within the next 2months, and whose Requesting/Treating Physician is requesting continued supply of the investigational medicinal product (IMP) known as TEV-48125 (fremanezumab) on behalf of the patient.
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Eligible patients may enter this CUP after successfully completing TV48125-CNS-30084 and all End of Study procedures
- In the opinion of your physician/investigator are able to continue IMP (fremanezumab) in a safe and compliant way.
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Exclusion Criteria
- Additional criteria may apply, please contact your physician/investigator for more information.
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Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method