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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00296192
Date of registration: 22/02/2006
Prospective Registration: No
Primary sponsor: UCB Pharma
Public title: Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms
Scientific title: A Double-Blind, Placebo-Controlled, Parallel-Group, Proof of Concept Trial to Assess the Tolerability, Safety, and Efficacy of Rotigotine Nasal Spray for the Acute Treatment of "OFF" Symptoms in Subjects With Advanced-Stage, Idiopathic Parkinson Disease
Date of first enrolment: February 2006
Target sample size: 82
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00296192
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
Germany
Contacts
Name:     UCB Clinical Trial Call Center
Address: 
Telephone:
Email:
Affiliation:  +1 877 822 9493 (UCB)
Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female subjects with idiopathic Parkinson's disease for at least 3 years in
duration

- At least 30 years of age

Exclusion Criteria:

- Patients with atypical Parkinson's or clinically relevant concomitant diseases or
medical conditions



Age minimum: 30 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Parkinson's Disease
Intervention(s)
Other: Placebo
Drug: Rotigotine nasal spray
Primary Outcome(s)
Number of Subjects Who Complete the Trial [Time Frame: 15 days]
Secondary Outcome(s)
Change From Baseline at 24 Minutes Post-dose in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination [Time Frame: Baseline, and 24 minutes post-dose]
Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min) [Time Frame: Baseline and 34 minutes post-dose]
"Success Rate" (Percentage of Subjects Achieving "Off" Reversals) [Time Frame: Up to 6 hours post-dose]
Time of First "Off" Reversal [Time Frame: Up to 6 hours post-dose]
Secondary ID(s)
SP0873
EudraCT: 2005-004290-19
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 29/01/2010
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00296192
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