Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa

Parkinson Disease, Idiopathic Clinical Trial

Official title:

A Multi-centre, Multi-national, Phase 3, Randomized, Double-blind, Double-dummy, 3- Arm Parallel Group, Placebo- and Pramipexole- Controlled Trial of the Efficacy and Safety of Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00244387
• Other study ID #: SP0515
• Status: Completed
• Phase: Phase 3
• First received: October 24, 2005
• Last updated: September 24, 2014
• Start date: March 2004
• Est. completion date: July 2005

Study information

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

Clinical Trial Summary

Male and female patients aged ≥ 30 years with advanced stage idiopathic Parkinson's disease, not well controlled on existing levodopa will take part in a research study at approximately 82 sites in Europe, Israel, South Africa, Australia and new Zealand.

The purpose of the study is to evaluate the effectiveness, safety and tolerability of the rotigotine patch (SPM 962) at an individual patient's optimal dose for a period of 4 months

Each patient who qualifies and chooses to participate in the study will receive either rotigotine, pramipexole, or placebo at gradually increasing doses over a period of up to 7 weeks, and then maintain their optimal dose for 4 months.

The study clinic visits will include a medical history and physical exam, ECG, blood and urine sample collection, completion of various questionnaires, and completion of a diary to record the severity of their Parkinson's symptoms.

Patients who complete the study may enroll in an extension trial and receive active study drug.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 506
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Advanced stage idiopathic Parkinson's disease

Exclusion Criteria:

• Well controlled on levodopa

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson Disease, Idiopathic

Intervention

Drug:
• SPM 962

Locations

Country	Name	City	State
Germany	Schwarz	Monheim

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Oertel W, LeWitt P, Giladi N, Ghys L, Grieger F, Boroojerdi B. Treatment of patients with early and advanced Parkinson's disease with rotigotine transdermal system: age-relationship to safety and tolerability. Parkinsonism Relat Disord. 2013 Jan;19(1):37- — View Citation

Pahwa R. Rotigotine skin patch for the treatment of fluctuating Parkinson's disease--how does it compare with pramipexole? Nat Clin Pract Neurol. 2007 Dec;3(12):656-7. Epub 2007 Sep 25. — View Citation

Poewe WH, Rascol O, Quinn N, Tolosa E, Oertel WH, Martignoni E, Rupp M, Boroojerdi B; SP 515 Investigators. Efficacy of pramipexole and transdermal rotigotine in advanced Parkinson's disease: a double-blind, double-dummy, randomised controlled trial. Lanc — View Citation

External Links

•   Clinical Study Summary on UCB.com