|
Main
|
|
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: |
|
|
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)
|
|
"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]
|
|
Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min)
[Time Frame: Baseline and 34 minutes post-dose]
|
|
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]
|
|
Secondary ID(s)
|
|
SP0873
|
|
EudraCT: 2005-004290-19
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|