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

Parkinson's Disease Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Cross-Over Study of Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02162979
• Other study ID #: 52031
• Status: Terminated
• Phase: Phase 2
• First received: December 26, 2007
• Last updated: March 5, 2018
• Start date: February 2002
• Est. completion date: January 2009

Study information

• Verified date: March 2018
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyskinesias
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• sildenafil
sildenafil 50mg BID for 2 weeks
• Placebo

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Duration of Dyskinesia.		2 weeks
Secondary	Percent Change in "on" Time	"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.	4 weeks
Secondary	Change in Dose of Anti-parkinsonian Medications		7 weeks