Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease - Full Text View

Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease

This study has been completed.

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00134251

Purpose

This study is a multicenter, randomized, double-blind, placebo controlled, parallel group study of a seven-week ascending dose period of SLV308 adjunctive to L-dopa treatment in patients with advanced stage Parkinson's disease (PD) and dose-dependent motor fluctuations. Patients (outpatients) will be randomized to one of three different treatment arms.

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

Genetics Home Reference related topics:

familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics:

Parkinson's Disease

ChemIDplus related topics:

Levodopa SLV-308

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Parallel Group Study Exploring Effects of SLV308 up to 42 mg/Day Administered as an Adjunctive Therapy to L-Dopa in Patients With Advanced Stage Parkinson’s Disease

Further study details as provided by Solvay Pharmaceuticals:

Study Start Date:

October 2005

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who have signed an informed consent; diagnosis of idiopathic PD.
Presence of recognizable "on" and "off" stages
Minimum hours of “off” time per day of 2.5 hours
Able to keep diaries.

Exclusion Criteria:

Unclear diagnosis or a suspicion of other parkinsonian syndromes
Have undergone surgical treatment for PD
History of non-response to L-dopa.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134251

Locations


Bulgaria
	Site 11
	Sofia, Bulgaria
	Site 12
	Sofia, Bulgaria
	Site 13
	Sofia, Bulgaria
	Site 14
	Sofia, Bulgaria
	Site 15
	Sofia, Bulgaria
	Site 16
	Plovdiv, Bulgaria

Malta
	Site 21
	Guardamangia, Malta

Serbia and Montenegro
	Site 33
	Nis, Serbia and Montenegro
	Site 31
	Belgrade, Serbia and Montenegro
	Site 34
	Belgrade, Serbia and Montenegro

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators


Study Director:	Global Clinical Director Solvay	Solvay Pharmaceuticals

More Information

Study ID Numbers:	S308.3.005, EuDract no 2005-002432-10
First Received:	August 22, 2005
Last Updated:	July 13, 2007
ClinicalTrials.gov Identifier:	NCT00134251
Health Authority:	Bulgaria: Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Malta: Ministry of Health

Keywords provided by Solvay Pharmaceuticals:

Parkinson's disease

adjunctive to L-dopa therapy

Advanced stage Parkinson's disease

Study placed in the following topic categories:

Levodopa

Ganglion Cysts

Movement Disorders

Parkinson Disease

Basal Ganglia Diseases

Dihydroxyphenylalanine

Central Nervous System Diseases

Parkinsonian Disorders

Neurodegenerative Diseases

Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 17, 2008