Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-31 @ 1:23 PM
Study NCT ID:
NCT01941732
Status:
COMPLETED
Last Update Posted:
2013-09-13
First Post:
2013-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motor Response to Sildenafil in PD
Sponsor:
Bispebjerg Hospital
Organization:
Study Overview
Official Title:
Motor Response to Acute Challenge to Sildenafil in Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: