Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch
Phase 3
Completed
- Registration Number
- CTRI/2009/091/001069
- Lead Sponsor
- SCHWARZ BIOSCIENCES, Inc.8010 Arco Corporate Drive, Suite 100 Raleigh, NC 27617, USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
Inclusion Criteria
1.Parkinson's Disease greater than 3 years
2.Stable dose L-dopa but symptoms not adequately
controlled and have "off" time
3.Able and willing to complete diary on specific days
Exclusion Criteria
1.Previous use of rotigotine or Neupro
2.Atypical Parkinson's syndrome
3.Pallidotomy
4.Thalamotomy
5.Deep brain stimulation
6.Fetal tissue transplant
7.Dementia
8.Psychosis
9.Hallucinations
10.Epilepsy
11.Renal or hepatic dysfunction
12.Clinically relevant cardiac dysfunction
13.Symptomatic orthostatic hypotension
14.Skin sensitivity to adhesives or unresolved contact
dermatitis
15.History of chronic alcohol or drug abuse
16.Pregnant or of child-bearing potential
17.Impulse control disorder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method