NCT01941732

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2003

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
9.5 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
Last Updated

September 13, 2013

Status Verified

September 1, 2013

Enrollment Period

3 months

First QC Date

September 10, 2013

Last Update Submit

September 10, 2013

Conditions

Parkinsons DiseaseErectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Motor function

    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.

    1 hour

Secondary Outcomes (1)

  • Cerebral Blood Flow (rCBF)

    1 hour

Study Arms (1)

Sildenafil

EXPERIMENTAL

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

Interventions

SildenafilDRUG
Also known as: Sildenafil (Viagra (R)) 100 mg
Sildenafil

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • psychosis
  • Heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Neurology, Bispebjerg Hospital

Copenhagen, DK2400NV, Denmark

Location

MeSH Terms

Conditions

Parkinson DiseaseErectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, ph.d.

Study Record Dates

First Submitted

September 10, 2013

First Posted

September 13, 2013

Study Start

November 1, 2003

Primary Completion

February 1, 2004

Study Completion

March 1, 2004

Last Updated

September 13, 2013

Record last verified: 2013-09

Locations

DK(1)