Motor Response to Sildenafil in PD
Primary Purpose
Parkinsons Disease, Erectile Dysfunction
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Sildenafil
Sponsored by
About this trial
This is an interventional treatment trial for Parkinsons Disease
Eligibility Criteria
Inclusion Criteria:
- Men
- Parkinsons disease
- Erectile dysfunction
- previous tried sildenafil with beneficial effects on motor function
Exclusion Criteria:
- psychosis
- Heart disease
Sites / Locations
- Dept of Neurology, Bispebjerg Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sildenafil
Arm Description
motor function to be tested before and after challenge with 100 mg sildenafil after taking normal anti-PD medication, and Again after discontinuation of anti-PD medication for 12 h
Outcomes
Primary Outcome Measures
Motor function
Motor function assessed by Unified Parkinsons disease Rating Scale, section 3 before and after challenge with Sildenafil and before and after discontinuation of anti-PD medication for 12 hours.
Secondary Outcome Measures
Cerebral Blood Flow (rCBF)
change in rCBF in basal ganglia from before to 1 hour after intake of 100 mg of sildenafil
Full Information
NCT ID
NCT01941732
First Posted
September 10, 2013
Last Updated
September 10, 2013
Sponsor
Bispebjerg Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01941732
Brief Title
Motor Response to Sildenafil in PD
Official Title
Motor Response to Acute Challenge to Sildenafil in Parkinsons Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
March 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Sildenafil (Viagra(R))is widely used by men with Parkinsons Disease (PD) and erectile dysfunction. A number of patients have reported that when they take Sildenafil, their need of anti-PD medication is reduced.
We hypotheses that sildenafil increases brain blood flow and hence improves the function of specific brain regions, improving motor function.
Motor function and cerebral blood flow of 8 patients will be tested before and after Sildenafil intake and before and after anti-PD medication.
Detailed Description
Erectile dysfunction can be experienced by up tp 40% of men with Parkinsons Disease (PD). Sildenafil (Viagra(R))is widely used by men with PD and erectile dysfunction. A number of patients have reported that when they take Sildenafil, their need of anti-PD medication is reduced.
We hypotheses that sildenafil increases cerebral blood flow in basal ganglia and hence improves the function, improving motor function.
Motor function and cerebral blood flow (rCBF) of 8 patients will be tested before and after Sildenafil intake and before and after anti-PD medication.
rCBF will be measured by the Xe133 inhalation method and a fast-rotating, brain-dedicated, single photon emission computerized tomograph (SPECT, Tomomatic, 232, Medimatic, Inc., Denmark). Two scans will be perfomed, when patients are i)in normal medicated state and ii) in normal medicated state 1 hour after intake of 100 mg sildenafil.
Motor function will be measured i 4 conditions: i)in normal medicated state and ii) in normal medicated state 1 hour after intake of 100 mg sildenafil, iii) after 12 hours of discontiation of anti-PD mediciation and iiii) after 14 hours of discontiation of anti-PD mediciation and 1 hour after intake of 100 mg sildenafil.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinsons Disease, Erectile Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sildenafil
Arm Type
Experimental
Arm Description
motor function to be tested before and after challenge with 100 mg sildenafil after taking normal anti-PD medication, and Again after discontinuation of anti-PD medication for 12 h
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Other Intervention Name(s)
Sildenafil (Viagra (R)) 100 mg
Primary Outcome Measure Information:
Title
Motor function
Description
Motor function assessed by Unified Parkinsons disease Rating Scale, section 3 before and after challenge with Sildenafil and before and after discontinuation of anti-PD medication for 12 hours.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Cerebral Blood Flow (rCBF)
Description
change in rCBF in basal ganglia from before to 1 hour after intake of 100 mg of sildenafil
Time Frame
1 hour
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men
Parkinsons disease
Erectile dysfunction
previous tried sildenafil with beneficial effects on motor function
Exclusion Criteria:
psychosis
Heart disease
Facility Information:
Facility Name
Dept of Neurology, Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
DK2400NV
Country
Denmark
12. IPD Sharing Statement
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Motor Response to Sildenafil in PD
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