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

Official title:

An Open-Label Extension to the Double-Blind SP513 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: NCT00599196
• Other study ID #: SP0716
• Secondary ID: SP513OL
• Status: Completed
• Phase: Phase 3
• First received: December 24, 2007
• Last updated: September 24, 2014
• Start date: August 2002
• Est. completion date: December 2008

Study information

• Verified date: September 2010
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyAustralia: Department of Health and Ageing Therapeutic Goods AdministrationCroatia: Ministry of Science, Education and SportsBelgium: Federal Agency for Medicines and Health Products, FAMHPCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Finland: Finnish Medicines AgencyHungary: National Institute of PharmacyIsrael: Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)New Zealand: Health Research CouncilNorway: Norwegian Medicines AgencyPoland: Ministry of HealthSouth Africa: Department of HealthSweden: Medical Products AgencySwitzerland: SwissmedicItaly: Ministry of HealthSpain: Comité Ético de Investigación ClínicaUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• 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- and ropinirole-controlled SP513 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: 381
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Subjects who have completed six months of maintenance treatment in the SP513 double-blind trial

Exclusion Criteria:

• Subjects who had an ongoing serious adverse event from SP513 double-blind trial that was assessed as related to study medication

Study Design

Endpoint Classification: Safety 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, once daily: 10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours); 50 cm2 (10 mg/24 hours); 60 cm2 (12 mg/24 hours); 70 cm2 (14 mg/24 hours); 80 cm2 (16 mg/24 hours); Optimal dosing: During the first year: The maximum Rotigotine dose allowed is 8 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

Australia,  Austria,  Belgium,  Croatia,  Czech Republic,  Finland,  France,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  New Zealand,  Norway,  Poland,  South Africa,  Spain,  Sweden,  Switzerland,  United Kingdom, 

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.	six 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.	six 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 10 (end of year 1), Visit 14 (end of year 2), Visit 18 (end of year 3), Visit 22 (end of year 4), Visit 26 (end of year 5), Visit 30 (end of year 6), End of Treatment (last study visit or early withdrawal visit)	No

External Links

•   FDA Safety Alerts and Recalls