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

Primary Purpose

Parkinson's Disease

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

sildenafil

Placebo

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, PD, dyskinesia, treatment, motor complications

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Atypical parkinsonian syndrome due to drugs, metabolic disorders, encephalitis, or degenerative diseases.
History of stereotaxic brain surgery.
Clinical history of dementia.
Known major psychiatric disorder, major depression, schizophrenia. Known alcoholism or substance dependence within previous 12 months.
History of major hematological, renal, or hepatic abnormalities.
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.
History of stroke within the last 6 months.
Abnormal EKG consistent with cardiac ischemia.
Treatment with nitrates. Nitrates or any NO donors in any dosage form (oral, sublingual, transdermal, inhalation, or aerosols).
Malignant hypertension or SBP . 180 or <90, or DBP .110 or <50.
History of priapism.
Known history of retinitis pigmentosa.
Positive pregnancy test.
History of bleeding disorder.
Patients with active peptic ulcer disease associated with bleeding.
Unwillingness to use adequate contraceptive methods if of childbearing potential.
Patients with medical or psychological condition or social circumstances that would impair their ability to participate in the study.
Use of Viagra or any experimental drugs within 30 days of screening visit.

Sites / Locations

Loma Linda University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Viagra

Placebo comparator

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Duration of Dyskinesia.

Secondary Outcome Measures

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.

Change in Dose of Anti-parkinsonian Medications

Full Information

NCT ID

NCT02162979

First Posted

December 26, 2007

Last Updated

March 5, 2018

Sponsor

Loma Linda University

1. Study Identification

Unique Protocol Identification Number

NCT02162979

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Terminated

Why Stopped

Not enough subjects.

Study Start Date

February 2002 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

Keywords

Parkinson's disease, PD, dyskinesia, treatment, motor complications

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Viagra

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo comparator

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

sildenafil

Other Intervention Name(s)

Viagra

Intervention Description

sildenafil 50mg BID for 2 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change in Duration of Dyskinesia.

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Percent Change in "on" Time

Description

Time Frame

4 weeks

Title

Change in Dose of Anti-parkinsonian Medications

Time Frame

7 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of idiopathic Parkinson's disease, Hoehn and Yahr stage 2.0 to 4.0. Presence of drug-induced dyskinesias Age>40 years. Willingness and ability to comply with the study requirements and give informed consent. Exclusion Criteria: Atypical parkinsonian syndrome due to drugs, metabolic disorders, encephalitis, or degenerative diseases. History of stereotaxic brain surgery. Clinical history of dementia. Known major psychiatric disorder, major depression, schizophrenia. Known alcoholism or substance dependence within previous 12 months. History of major hematological, renal, or hepatic abnormalities. 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. History of stroke within the last 6 months. Abnormal EKG consistent with cardiac ischemia. Treatment with nitrates. Nitrates or any NO donors in any dosage form (oral, sublingual, transdermal, inhalation, or aerosols). Malignant hypertension or SBP . 180 or <90, or DBP .110 or <50. History of priapism. Known history of retinitis pigmentosa. Positive pregnancy test. History of bleeding disorder. Patients with active peptic ulcer disease associated with bleeding. Unwillingness to use adequate contraceptive methods if of childbearing potential. Patients with medical or psychological condition or social circumstances that would impair their ability to participate in the study. Use of Viagra or any experimental drugs within 30 days of screening visit.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David M. Swope, MD

Organizational Affiliation

Loma Linda University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Loma Linda University

City

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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