Abstract Details

Title Phase II Proof of Concept Study To Compare a Novel Levodopa Product ODM-101 to Levodopa/Carbidopa/Entacapone in Parkinson's Disease Patients with Response Fluctuations

Topic Movement Disorders

Presentation(s) S23 - (-)

Poster/Presentation
Number 005

Objective

Background Levodopa treatments with higher and more reliable efficacy are needed in fluctuating PD patients. ODM-101 (same components as LCE) contains a higher amount of carbidopa (either 65 or 105 mg) regardless of levodopa dosage. Phase I studies with ODM-101 have indicated improved pharmacokinetic profile of levodopa compared with LCE.

Design/Methods This was a randomized, double-blind, cross-over study with 3 periods each lasting for 4 weeks. Study treatments were LCE, ODM-101/65 mg and ODM-101/105 mg. Inclusion criteria were PD with ? 3.0 hours of OFF-time during 3 consecutive days prior to study entry. Daily OFF-time (primary end-point) and ON-time with and without troublesome dyskinesia were measured by patient diary.

Results 117 patients were randomized. Changes in OFF-times (from baseline) were -1.51 (95% CI: -1.97, -1.05) for ODM-101/65mg, -1.29 (-1.75, -0.83) for ODM-101/105mg and -0.92 (-1.38, -0.47) h for LCE. There was significant carry-over effect (p=0.048) and carry-over adjusted OFF-times were -1.53 (-2.05, -1.01) for ODM-101/65mg (p=0.02 vs LCE), -1.57 (-2.08, -1.05) for ODM-101/105mg (p=0.01 vs LCE) and -0.91 (-1.37, -0.46) h for LCE. Carry-over adjusted ON-times (change from baseline) without troublesome dyskinesia were 1.55 (1.00, 2.11) for ODM-101/65mg (p=0.05 vs LCE), 1.62 0.28 (1.07, 2.16) for ODM-101/105mg (p=0.03 vs LCE) and 0.99 (0.51, 1.47) h for LCE. There were no significant differences between the treatments in ON-time with troublesome dyskinesia or in UPDRS II and III scores. No new safety concerns were observed for any treatments. Dyskinesias reported as spontaneous adverse events were more commonly reported for ODM-101/105 mg vs other treatments.

Conclusions Both ODM-101 dosages significantly decreased daily OFF-time vs LCE without increasing ON-time with troublesome dyskinesia. No new safety findings were observed.

Authors/Disclosures
Mikko Kuoppamaki (Orion Pharma) PRESENTER	No disclosure on file
Claudia Trenkwalder, MD (Center For Parkinsonism and Movement Disorders)	Dr. Trenkwalder has received personal compensation for serving as an employee of Paracelsus-Kliniken. Dr. Trenkwalder has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Trenkwalder has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Trenkwalder has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Trenkwalder has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bial. Dr. Trenkwalder has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Trenkwalder has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Esteve. Dr. Trenkwalder has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Convatec. Dr. Trenkwalder has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boehringer. Dr. Trenkwalder has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. The institution of Dr. Trenkwalder has received research support from DLR /BMBF. Dr. Trenkwalder has received intellectual property interests from a discovery or technology relating to health care.
	No disclosure on file
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Klemens Ruprecht, MD (Klinik fur Neurologie)	Dr. Ruprecht has received research support from European Union (821283-2). Dr. Ruprecht has received research support from Merck Serono. Dr. Ruprecht has received research support from Stiftung Charite. Dr. Ruprecht has received research support from Arthur Arnstein Foundation. Dr. Ruprecht has received publishing royalties from a publication relating to health care.
Pietro Annovazzi	No disclosure on file

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