Motor Response to Sildenafil in PD

Phase 4

Completed

• Conditions: Parkinsons Disease; Erectile Dysfunction
• Interventions: Drug: Sildenafil

• Registration Number: NCT01941732
• Lead Sponsor: Bispebjerg Hospital

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.

Study Timeline

• Study Start: 2003-11
• Primary Completion: 2004-02
• Study Completion: 2004-03
• Status Verified: 2013-09
• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-10
• Last Update Submitted: 2013-09-10
• Study First Posted: 2013-09-13
• Last Update Posted: 2013-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• Men
• Parkinsons disease
• Erectile dysfunction
• previous tried sildenafil with beneficial effects on motor function

Exclusion Criteria

• psychosis
• Heart disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sildenafil	Sildenafil	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

Primary Outcome Measures

Name	Time	Method
Motor function	1 hour	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

Name	Time	Method
Cerebral Blood Flow (rCBF)	1 hour	change in rCBF in basal ganglia from before to 1 hour after intake of 100 mg of sildenafil

Trial Locations

Locations (1)

Dept of Neurology, Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark