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

Early-Stage Parkinson's Disease Clinical Trial

— SP512OL  

Official title:

An Open-Label Extension to the Double-Blind SP512 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594165
• Other study ID #: SP0702
• Secondary ID: SP512OL
• Status: Completed
• Phase: Phase 3
• First received: December 24, 2007
• Last updated: September 24, 2014
• Start date: June 2002
• Est. completion date: November 2008

Study information

• Verified date: September 2010
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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 early-stage idiopathic Parkinson's disease.

Description:

This is the open-label extension to the randomized, double-blind, placebo-controlled SP512 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 31 Years and older

Eligibility

Inclusion Criteria:

• Subjects who have completed six months of maintenance treatment in the SP512 double-blind trial

Exclusion Criteria:

• Subjects who had an ongoing serious adverse event from SP512 double-blind trial that was assessed as related to study medication

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Early-Stage Parkinson's Disease
• Parkinson Disease

Intervention

Drug:
• Rotigotine
Rotigotine trans-dermal patches: 10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) Optimal dosing: During the first year: The maximum Rotigotine dose allowed is 6 mg/24 hours. After the first year: allowed dose increase of Rotigotine up to a maximum of 16 mg/24 hours.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Elmer LW, Surmann E, Boroojerdi B, Jankovic J. Long-term safety and tolerability of rotigotine transdermal system in patients with early-stage idiopathic Parkinson's disease: a prospective, open-label extension study. Parkinsonism Relat Disord. 2012 Jun;1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With at Least One Adverse Event During This Open-label Extension Study	Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.	7 years	No
Secondary	Number of Subjects Who Withdrew From the Trial Due to an Adverse Event.	Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.	7 years	No
Secondary	Mean Epworth Sleepiness Scale Score During the Open-label Extension.	The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.	Visit 9 (end of year 1), Visit 13 (end of year 2), Visit 17 (end of year 3), Visit 21(end of year 4), Visit 25 (end of year 5), Visit 29 (end of year 6), End of Treatment (last study visit or early withdrawal visit)	No

External Links

•   FDA Safety Alerts and Recalls