Parkinson's Disease
Conditions
Keywords
Parkinson's disease, PD, dyskinesia, treatment, motor complications
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.
Interventions
DRUGsildenafil
sildenafil 50mg BID for 2 weeks
DRUGPlacebo
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Duration of Dyskinesia. | 2 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United States
Participant flow
Pre-assignment details
Documentation regarding the randomization of the two enrolled participants cannot be located. Therefore no meaningful data are available for entry in the data tables.
Participants by arm
| Arm | Count |
|---|---|
| Viagra subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.
sildenafil: sildenafil 50mg BID for 2 weeks | 0 |
| 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.
Placebo | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in Duration of Dyskinesia.
Time frame: 2 weeks
Secondary
Change in Dose of Anti-parkinsonian Medications
Time frame: 7 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.
Time frame: 4 weeks