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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

Tracking Information
First Submitted Date  ICMJE December 26, 2007
First Posted Date  ICMJE June 13, 2014
Results First Submitted Date  ICMJE June 20, 2014
Results First Posted Date  ICMJE July 22, 2014
Last Update Posted Date March 30, 2018
Study Start Date  ICMJE February 2002
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2014)
Change in Duration of Dyskinesia. [ Time Frame: 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
  • 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.
  • Change in Dose of Anti-parkinsonian Medications [ Time Frame: 7 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2014)
  • Percent Change in "on" Time [ Time Frame: 4 weeks ]
  • Change in Dose of Anti-parkinsonian Medications [ Time Frame: 7 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's Disease
Official Title  ICMJE A Double-Blind, Placebo-Controlled, Cross-Over Study of Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's Disease
Brief Summary This study is to determine if Viagra is effective in reducing dyskinesias in patients with Parkinson's Disease.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Drug: sildenafil
    sildenafil 50mg BID for 2 weeks
    Other Name: Viagra
  • Drug: Placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: sildenafil
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 12, 2014)
2
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02162979
Other Study ID Numbers  ICMJE 52031
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Loma Linda University
Study Sponsor  ICMJE Loma Linda University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David M. Swope, MD Loma Linda University
PRS Account Loma Linda University
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP