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

Phase 2

Terminated

• Conditions: Parkinson's Disease
• Interventions: Drug: Placebo; Drug: sildenafil

• Registration Number: NCT02162979
• Lead Sponsor: Loma Linda University

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 Timeline

• Study Start: 2002-02
• Study First Submitted: 2007-12-26
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-13
• Results First Submitted: 2014-06-20
• Results First Submitted QC: 2014-06-20
• Results First Posted: 2014-07-22
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-05
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo comparator	Placebo	subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.
Viagra	sildenafil	subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

Primary Outcome Measures

Name	Time	Method
Change in Duration of Dyskinesia.	2 weeks

Secondary Outcome Measures

Name	Time	Method
Percent Change in "on" Time	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	7 weeks

Trial Locations

Locations (1)

Loma Linda University; 🇺🇸 Loma Linda, California, United States