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

NCT ID: NCT02162979

Last Updated: 2018-03-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2009-01-31

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Viagra

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

Group Type: EXPERIMENTAL

sildenafil

Intervention Type: DRUG

sildenafil 50mg BID for 2 weeks

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

sildenafil

sildenafil 50mg BID for 2 weeks

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Viagra

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David M. Swope, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Loma Linda University

Loma Linda, California, United States

Countries

United States

Other Identifiers

52031

Identifier Type: -

Identifier Source: org_study_id