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Motor Response to Sildenafil in PD

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ClinicalTrials.gov Identifier: NCT01941732
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : September 13, 2013
Sponsor:
Information provided by (Responsible Party):
Kristian Winge, 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.


Condition or disease Intervention/treatment Phase
Parkinsons Disease Erectile Dysfunction Drug: Sildenafil Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Motor Response to Acute Challenge to Sildenafil in Parkinsons Disease
Study Start Date : November 2003
Actual Primary Completion Date : February 2004
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: Sildenafil
Other Name: Sildenafil (Viagra (R)) 100 mg




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • psychosis
  • Heart disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941732


Locations
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Denmark
Dept of Neurology, Bispebjerg Hospital
Copenhagen, Denmark, DK2400NV
Sponsors and Collaborators
Bispebjerg Hospital

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Responsible Party: Kristian Winge, Consultant, ph.d., Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01941732     History of Changes
Other Study ID Numbers: VIA-Pilot1
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: September 13, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
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Parkinson Disease
Erectile Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents