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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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02635841
Study type Expanded Access
Source Chiesi Canada Corp
Contact
Status No longer available
Phase

See also
  Status Clinical Trial Phase
Completed NCT02174848 - Long-term Deferiprone Treatment in Patients With Pantothenate Kinase-Associated Neurodegeneration Phase 3
Terminated NCT03041116 - Efficacy and Safety Study of Fosmetpantotenate (RE-024) in PKAN Participants Phase 3
Active, not recruiting NCT04182763 - CoA-Z in Pantothenate Kinase-associated Neurodegeneration (PKAN) N/A
Completed NCT01741532 - Efficacy and Safety Study of Deferiprone in Patients With Pantothenate Kinase-associated Neurodegeneration (PKAN) Phase 3