A Phase 3, Randomized Controlled Study of IPX203
Research type
Research Study
Full title
A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations.
IRAS ID
259840
Contact name
Yen Foung Tai
Contact email
Sponsor organisation
Impax Laboratories, LLC
Eudract number
2018-002233-37
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 10 months, 16 days
Research summary
This research study is testing the safety and efficacy of IPX203 (an investigational drug containing carbidopa and levodopa) compared to a marketed form of immediate release carbidopa-levodopa (IR CD-LD) with patients with Parkinson's disease.
Parkinson's disease is a degenerative disorder of the central nervous system (the part of the nervous system that consists of the brain and spinal cord). The symptoms of Parkinson's disease result from the loss of dopamine-generating cells in the brain. Dopamine is a chemical released by nerve cells to send signals to other nerve cells. Symptoms of Parkinson’s disease can include shaking, rigidity, slowness of movement and difficulty with walking.
IPX203 is an investigational extended-release (i.e. releases drug more slowly) capsule formulation of carbidopa-levodopa (CD-LD) administered orally (by mouth). It is being investigated for its potential as a possible treatment of Parkinson’s disease symptoms.
The aim of this study is to test the safety and efficacy of IPX203 compared to IR CD-LD in participants with Parkinson’s disease.
This study is being conducted at multiple clinical sites in the United States, United Kingdom and EuropeREC name
London - Fulham Research Ethics Committee
REC reference
19/LO/1183
Date of REC Opinion
11 Oct 2019
REC opinion
Further Information Favourable Opinion