An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease

UCB

Status and phase: Completed; Phase 3

Conditions: Advanced Stage Parkinson's Disease

Treatments: Drug: Rotigotine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00501969

2004-000148-26 (EudraCT Number)

SP0516

Details and patient eligibility

About

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with advanced-stage idiopathic Parkinson's disease

Full description

This is the open-label extension to the randomized, double-blind, placebo-and active controlled SP515 (NCT00244387) trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease that were not well-controlled on levodopa

Enrollment: 395 patients

Sex: All

Ages: 31+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who have completed four months of maintenance treatment in the SP515 (NCT00244387) double-blind trial

Exclusion criteria

• Subjects who had an ongoing serious adverse event from SP515 (NCT00244387) double-blind trial that was assessed as related to study medication

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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395 participants in 1 patient group

Rotigotine

Experimental group

Description:

Rotigotine

Treatment:

Drug: Rotigotine