This study is a multicenter, randomized, double blind, parallel group study of 6 months’ treatment with SLV308 administered as a monotherapy in patients with early stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.

Condition	Intervention	Phase
Early Stage Parkinson''''s Disease	Drug: SLV308	Phase III

Ages Eligible for Study:  30 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients who have signed informed consent, diagnosis of idiopathic Parkinson’s Disease, early stage of disease, Modified Hoehn & Yahr up to stage III, UPDRS motor score (part III) 10 at baseline.

Exclusion Criteria:

• Diagnosis is unclear or a suspicion of other parkinsonian syndromes, patients who have undergone surgery for the treatment of PD, presence of dyskinesias, motor fluctuations or loss of postural reflexes, clinically significant abnormalities, patients treated with L-dopa or dopamine agonists currently or in the past (for more than 3 months in total), antipsychotic.

Please refer to this study by ClinicalTrials.gov identifier  NCT00269516

Erik Van Leeuwen       erik.vanleeuwen@solvay.com

Study chairs or principal investigators

Global Clinical Director Solvay,  Study Director,  Solvay Pharmaceuticals   

Study ID Numbers:  S308.3.001
Last Updated:  December 22, 2005
Record first received:  December 22, 2005
ClinicalTrials.gov Identifier:  NCT00269516
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10