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Motor Response to Sildenafil in PD

NCT ID: NCT01941732

Last Updated: 2013-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2004-03-31

Brief Summary

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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

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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.

Conditions

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Parkinsons Disease Erectile Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Sildenafil

Intervention Type DRUG

Interventions

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Sildenafil

Intervention Type DRUG

Other Intervention Names

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Sildenafil (Viagra (R)) 100 mg

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* psychosis
* Heart disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kristian Winge

Consultant, ph.d.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dept of Neurology, Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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VIA-Pilot1

Identifier Type: -

Identifier Source: org_study_id