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Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162979
Recruitment Status : Terminated (Not enough subjects.)
First Posted : June 13, 2014
Results First Posted : July 22, 2014
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Loma Linda University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Parkinson's Disease
Interventions Drug: sildenafil
Drug: Placebo
Enrollment 2
Recruitment Details  
Pre-assignment Details Documentation regarding the randomization of the two enrolled participants cannot be located. Therefore no meaningful data are available for entry in the data tables.
Arm/Group Title Viagra Placebo Comparator
Hide Arm/Group Description

subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

sildenafil: sildenafil 50mg BID for 2 weeks

subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

Placebo

Period Title: Overall Study
Started 0 0
Completed 0 0
Not Completed 0 0
Arm/Group Title Viagra Placebo Comparator Total
Hide Arm/Group Description

subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

sildenafil: sildenafil 50mg BID for 2 weeks

subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Number Analyzed 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Age, Continuous  
Unit of measure:  Years
Number Analyzed 0 participants 0 participants 0 participants
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
1.Primary Outcome
Title Change in Duration of Dyskinesia.
Hide Description [Not Specified]
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Viagra Placebo Comparator
Hide Arm/Group Description:

subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

sildenafil: sildenafil 50mg BID for 2 weeks

subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

Placebo

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Percent Change in "on" Time
Hide Description "on" time is the period in which the subject is symptom free. We will track the amount of time the subject is considered symptom free before and after treatment. This value will be represented as a percent change.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Viagra Placebo Comparator
Hide Arm/Group Description:

subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

sildenafil: sildenafil 50mg BID for 2 weeks

subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

Placebo

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change in Dose of Anti-parkinsonian Medications
Hide Description [Not Specified]
Time Frame 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Viagra Placebo Comparator
Hide Arm/Group Description:

subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

sildenafil: sildenafil 50mg BID for 2 weeks

subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

Placebo

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Viagra Placebo Comparator
Hide Arm/Group Description

subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

sildenafil: sildenafil 50mg BID for 2 weeks

subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

Placebo

All-Cause Mortality
Viagra Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Viagra Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Viagra Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tonya Hamilton, reszearch Compliance Auditor
Organization: Loma Linda University
Phone: 909-558-4908
EMail: thamilton@llu.edu
Layout table for additonal information
Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT02162979    
Other Study ID Numbers: 52031
First Submitted: December 26, 2007
First Posted: June 13, 2014
Results First Submitted: June 20, 2014
Results First Posted: July 22, 2014
Last Update Posted: March 30, 2018