Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Brief Summary:
This study is to determine if Viagra is effective in reducing dyskinesias in patients with Parkinson's Disease.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: sildenafil Drug: Placebo Phase 2

Detailed Description:

Inclusion Criteria:

  1. Diagnosis of idiopathic Parkinson's disease.
  2. Age > 40 years.
  3. willingness and ability to comply with the study requirements and give informed consent.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Cross-Over Study of Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's Disease
Study Start Date : February 2002
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009


Arm Intervention/treatment
Experimental: Viagra
subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.
Drug: sildenafil
sildenafil 50mg BID for 2 weeks
Other Name: Viagra

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



Primary Outcome Measures :
  1. Change in Duration of Dyskinesia. [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Percent Change in "on" Time [ Time Frame: 4 weeks ]
    "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.

  2. Change in Dose of Anti-parkinsonian Medications [ Time Frame: 7 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of idiopathic Parkinson's disease, Hoehn and Yahr stage 2.0 to 4.0.
  2. Presence of drug-induced dyskinesias
  3. Age>40 years.
  4. Willingness and ability to comply with the study requirements and give informed consent.

Exclusion Criteria:

  1. Atypical parkinsonian syndrome due to drugs, metabolic disorders, encephalitis, or degenerative diseases.
  2. History of stereotaxic brain surgery.
  3. Clinical history of dementia.
  4. Known major psychiatric disorder, major depression, schizophrenia. Known alcoholism or substance dependence within previous 12 months.
  5. History of major hematological, renal, or hepatic abnormalities.
  6. Known coronary artery disease including angina or myocardial infarction within the last 6 months. Significant cardiovascular disease including cardiac failure, unstable angina or life-threatening arrhythmia within the last 6 months.
  7. History of stroke within the last 6 months.
  8. Abnormal EKG consistent with cardiac ischemia.
  9. Treatment with nitrates. Nitrates or any NO donors in any dosage form (oral, sublingual, transdermal, inhalation, or aerosols).
  10. Malignant hypertension or SBP . 180 or <90, or DBP .110 or <50.
  11. History of priapism.
  12. Known history of retinitis pigmentosa.
  13. Positive pregnancy test.
  14. History of bleeding disorder.
  15. Patients with active peptic ulcer disease associated with bleeding.
  16. Unwillingness to use adequate contraceptive methods if of childbearing potential.
  17. Patients with medical or psychological condition or social circumstances that would impair their ability to participate in the study.
  18. Use of Viagra or any experimental drugs within 30 days of screening visit.

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): NCT02162979


Locations
Layout table for location information
United States, California
Loma Linda University
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Layout table for investigator information
Principal Investigator: David M. Swope, MD Loma Linda University
Layout table for additonal information
Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT02162979    
Other Study ID Numbers: 52031
First Posted: June 13, 2014    Key Record Dates
Results First Posted: July 22, 2014
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Loma Linda University:
Parkinson's disease
PD
dyskinesia
treatment
motor complications
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents