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Motor Response to Sildenafil in PD

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01941732
Collaborator
(none)
8
Enrollment
1
Location
1
Arm
4
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
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 :
Nov 1, 2003
Actual Primary Completion Date :
Feb 1, 2004
Actual Study Completion Date :
Mar 1, 2004

Arms and Interventions

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 Names:
  • Sildenafil (Viagra (R)) 100 mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Cerebral Blood Flow (rCBF) [1 hour]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Men

    • Parkinsons disease

    • Erectile dysfunction

    • previous tried sildenafil with beneficial effects on motor function

    Exclusion Criteria:

    • psychosis

    • Heart disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept of Neurology, Bispebjerg Hospital Copenhagen Denmark DK2400NV

    Sponsors and Collaborators

    • Bispebjerg Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kristian Winge, Consultant, ph.d., Bispebjerg Hospital
    ClinicalTrials.gov Identifier:
    NCT01941732
    Other Study ID Numbers:
    • VIA-Pilot1
    First Posted:
    Sep 13, 2013
    Last Update Posted:
    Sep 13, 2013
    Last Verified:
    Sep 1, 2013
    Additional relevant MeSH terms:
    Parkinson Disease
    Erectile Dysfunction
    Sildenafil Citrate

    Study Results

    No Results Posted as of Sep 13, 2013