Motor Response to Sildenafil in PD

Erectile Dysfunction Clinical Trial

Official title:

Motor Response to Acute Challenge to Sildenafil in Parkinsons Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941732
• Other study ID #: VIA-Pilot1
• Status: Completed
• Phase: Phase 4
• First received: September 10, 2013
• Last updated: September 10, 2013
• Start date: November 2003
• Est. completion date: March 2004

Study information

• Verified date: September 2013
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Men

• Parkinsons disease

• Erectile dysfunction

• previous tried sildenafil with beneficial effects on motor function

Exclusion Criteria:

• psychosis

• Heart disease

Related Conditions & MeSH terms

• Erectile Dysfunction
• Parkinson Disease
• Parkinsons Disease

Intervention

Drug:
• Sildenafil

Locations

Country	Name	City	State
Denmark	Dept of Neurology, Bispebjerg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 hour
Secondary	Cerebral Blood Flow (rCBF)	change in rCBF in basal ganglia from before to 1 hour after intake of 100 mg of sildenafil	1 hour