Clinical Trial Details
— Status: No longer available
Administrative data
NCT number |
NCT02635841 |
Other study ID # |
TIRCON2012V1-COMP |
Secondary ID |
|
Status |
No longer available |
Phase |
|
First received |
|
Last updated |
|
Study information
Verified date |
November 2022 |
Source |
Chiesi Canada Corp |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Expanded Access
|
Clinical Trial Summary
Patients with pantothenate kinase-associated neurodegeneration (PKAN) who have completed the
ApoPharma-sponsored study TIRCON2012V1-EXT and who wish to continue to take deferiprone will
be offered the opportunity to receive it on a compassionate basis. Patients will be followed
locally by their own neurologist or other appropriate specialist.
Description:
Patients with PKAN who have completed both the randomized, blinded, placebo-controlled trial
TIRCON2012V1 and its follow-up, the single-arm open-label extension study TIRCON2012V1-EXT,
may enroll in this compassionate-use/expanded access program in order to continue receiving
the iron chelator deferiprone. Participants in this program will be followed locally by their
own neurologist or other appropriate specialist. Patients will take deferiprone oral solution
80 mg/mL at the same dose they were prescribed in the TIRCON2012V1-EXT clinical trial. Safety
monitoring of the patients will be performed. At a minimum, the program will continue until
the analysis of the currently blinded TIRCON2012V1 trial is completed (approximately Q4
2016), at which time it will be re-evaluated.