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

NCT00244387 | Completed Phase 3

• 1 other identifier: SP0515
• Study Type: interventional
• Target: 506
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease, Idiopathic

Keywords

advanced stage idiopathic Parkinson's disease

Interventions

SPM 962 DRUG

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced stage idiopathic Parkinson's disease

You may not qualify if:

• Well controlled on levodopa

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (1)

Schwarz

Monheim, Germany

Location

Related Publications (4)

• 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. Lancet Neurol. 2007 Jun;6(6):513-20. doi: 10.1016/S1474-4422(07)70108-4.

  PMID: 17509486 RESULT

• 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. doi: 10.1038/ncpneuro0632. Epub 2007 Sep 25. No abstract available.

  PMID: 17895872 RESULT

• 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):37-42. doi: 10.1016/j.parkreldis.2012.06.009. Epub 2012 Sep 3.

  PMID: 22954721 RESULT

• LeWitt PA, Poewe W, Elmer LW, Asgharnejad M, Boroojerdi B, Grieger F, Bauer L. The Efficacy Profile of Rotigotine During the Waking Hours in Patients With Advanced Parkinson's Disease: A Post Hoc Analysis. Clin Neuropharmacol. 2016 Mar-Apr;39(2):88-93. doi: 10.1097/WNF.0000000000000133.

  PMID: 26882318 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• UCB Clinical Trial Call Center

  UCB Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 24, 2005
• First Posted: October 26, 2005
• Study Start: March 1, 2004
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: September 25, 2014

Record last verified: 2010-02

Locations

DE (1)