A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD

• Conditions: Parkinson's disease; MedDRA version: 7.0Level: LLTClassification code 10061536

• Registration Number: EUCTR2004-000185-12-SE
• Lead Sponsor: Orion Corporation, ORION PHARMA, 02200 Espoo, Finland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 740

Inclusion Criteria

• Male or female subjects
• Aged 30 to 70 years, inclusive
• A clinical diagnosis of idiopathic Parkinson’s disease (having at least 2 of the following three cardinal signs: resting tremor, bradykinesia, rigidity) with asymmetric symptom onset.
• Modified Hoehn and Yahr stage 1.0 to 2.5
• Maximum disease duration of 5 years, based on diagnosis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• History, signs or symptoms suggesting the diagnosis of atypical or secondary parkinsonism
• Presence at baseline of drug-related wearing-off symptoms, dyskinesias or other motor complications, using questionnaire consistent with outcome assessment.
• Previous or current levodopa or COMT inhibitor exposure. Current use of amantadine, or memantine and previous use at any time within 60 days prior to visit 1.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified