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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00594386
• Date of registration: 24/12/2007
• Prospective Registration: No
• Primary sponsor: UCB Pharma
• Public title: An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's Disease SP715
• Scientific title: An Open-Label Extension to the Double-Blind SP650 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease.
• Date of first enrolment: August 2002
• Target sample size: 258
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00594386
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Canada, United States

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: [phone] (UCB)

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects who have completed six months of maintenance treatment in the SP650
double-blind trial

Exclusion Criteria:

- Subjects who had an ongoing serious adverse event from the SP650 double-blind trial
that was assessed as related to study medication



Age minimum: 31 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Rotigotine

Primary Outcome(s)

Number of Subjects With at Least One Adverse Event During This Open-label Extension Study [Time Frame: 6 years]

Secondary Outcome(s)

Mean Epworth Sleepiness Scale Score During the Open-label Extension. [Time Frame: Visit 11 (end of year 1), Visit 15 (end of year 2), Visit 19 (end of year 3), Visit 23 (end of year 4), Visit 27 (end of year 5), Visit 31 (end of year 6), End of Treatment (last study visit or early withdrawal visit)]

Number of Subjects Who Withdrew From the Trial Due to an Adverse Event. [Time Frame: 6 years]

Secondary ID(s)

SP0715

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/12/2009
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00594386