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Completed

NCT Number: NCT01941732

Motor Response to Sildenafil in PD

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • psychosis
  • Heart disease

Treatment and study plan

Sildenafil

Drug

Other names: Sildenafil (Viagra (R)) 100 mg

Primary outcomes

  1. Motor function

    Time frame: 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 outcomes

  1. Cerebral Blood Flow (rCBF)

    Time frame: 1 hour

    change in rCBF in basal ganglia from before to 1 hour after intake of 100 mg of sildenafil

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

Motor Response to Acute Challenge to Sildenafil in Parkinsons Disease

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Sep 13, 2013
Registry last updated
Sep 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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