An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease

UCB

Status and phase: Completed; Phase 3

Conditions: Idiopathic Parkinson's Disease

Treatments: Drug: Rotigotine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00505687

2004-002641-12 (EudraCT Number)

SP0833

Details and patient eligibility

About

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of rotigotine in subjects with idiopathic PD.

Full description

This is the open-label extension to the open-label trials SP824 (NCT00242008), SP825 (NCT00243971), and SP826 (NCT00243945) that assessed the efficacy and safety and tolerability of rotigotine in subjects with idiopathic Parkinson's Disease.

Enrollment: 186 patients

Sex: All

Ages: 31+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who have completed treatment in one of the SP824 (NCT00242008), SP825 (NCT00243971), or SP826 (NCT00243945) trials

Exclusion criteria

• Subjects who had an ongoing serious adverse event from the previous OLE 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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186 participants in 1 patient group

Rotigotine

Experimental group

Description:

Rotigotine

Treatment:

Drug: Rotigotine