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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00599196
First received: December 24, 2007
Last updated: September 24, 2014
Last verified: September 2010

December 24, 2007
September 24, 2014
August 2002
December 2008   (final data collection date for primary outcome measure)
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study [ Time Frame: six years ] [ Designated as safety issue: No ]
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Long term safety and tolerability will be determined by Adverse Events, as well as by changes from baseline in vital signs, ECG, clinical laboratory and neurological examination and the Epworth Sleepiness Scale score [ Time Frame: Baseline of double-blind phase to end of treatment ]
Complete list of historical versions of study NCT00599196 on ClinicalTrials.gov Archive Site
  • Number of Subjects Who Withdrew From the Trial Due to an Adverse Event [ Time Frame: six years ] [ Designated as safety issue: No ]
    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
  • Mean Epworth Sleepiness Scale Score During the Open-label Extension [ Time Frame: 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) ] [ Designated as safety issue: No ]
    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.
Changes in UPDRS scores, Clinical Global Impression, Hoehn and Yahr stages, Changes in quality of life [ Time Frame: Baseline of double-blind phase to end of treatment ]
Not Provided
Not Provided
 
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease
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

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

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

Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Early Stage Parkinson's Disease
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.

Other Name: Neupro®
Experimental: Rotigotine
Rotigotine
Intervention: Drug: Rotigotine
Giladi N, Boroojerdi B, Surmann E. The safety and tolerability of rotigotine transdermal system over a 6-year period in patients with early-stage Parkinson's disease. J Neural Transm. 2013 Sep;120(9):1321-9. doi: 10.1007/s00702-013-1001-5. Epub 2013 Mar 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
381
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Croatia,   Czech Republic,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   New Zealand,   Norway,   Poland,   South Africa,   Spain,   Sweden,   Switzerland,   United Kingdom
 
NCT00599196
SP0716, SP513OL
No
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP