Motor Response to Sildenafil in PD

Bispebjerg Hospital

Status and phase: Completed; Phase 4

Conditions: Erectile Dysfunction; Parkinsons Disease

Treatments: Drug: Sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT01941732

VIA-Pilot1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• psychosis
• Heart disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Sildenafil

Experimental group

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

Treatment:

Drug: Sildenafil