Fremanezumab Managed Access Program for Pediatric Patients
ConditionMigraine
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age6-17
SponsorTeva Branded Pharmaceutical Products R&D LLC
About this trial
This is a Managed Access Program (MAP) based on a licensed physician's unsolicited request on a compassionate basis. Specifically, this MAP 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Additional criteria may apply, please contact your physician/investigator for more information.
Trial design
Treatments tested in this trial
Fremanezumab
DrugFor patients who enter this program, the monthly dose of fremanezumab to be administered will be confirmed or adjusted, as appropriate, based on the patient's weight every 3 months.
Treatment groups
No treatment groups listed
Trial outcomes
This trial has no outcomes listed.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov