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

NCT02162979 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 52031
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson's Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Duration of Dyskinesia.

  2 weeks

Secondary Outcomes (2)

• Percent Change in "on" Time

  4 weeks

• Change in Dose of Anti-parkinsonian Medications

  7 weeks

Study Arms (2)

Viagra

EXPERIMENTAL

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

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.

Drug: Placebo

Interventions

sildenafil DRUG

sildenafil 50mg BID for 2 weeks

Also known as: Viagra

Viagra

Placebo DRUG

Placebo comparator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Dyskinesias

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Tonya Hamilton, reszearch Compliance Auditor
• Organization: Loma Linda University

thamilton@llu.edu

909-558-4908

Study Officials

• David M. Swope, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: June 13, 2014
• Study Start: February 1, 2002
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: March 30, 2018
• Results First Posted: July 22, 2014

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)