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Not enough subjects.
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This study is to determine if Viagra is effective in reducing dyskinesias in patients with Parkinson's Disease.
Inclusion Criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sildenafil | Drug | sildenafil 50mg BID for 2 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Duration of Dyskinesia. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Change in Dose of Anti-parkinsonian Medications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David M. Swope, MD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92354 | United States |
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Documentation regarding the randomization of the two enrolled participants cannot be located. Therefore no meaningful data are available for entry in the data tables.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo Comparator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Duration of Dyskinesia. | Posted | 2 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tonya Hamilton, reszearch Compliance Auditor | Loma Linda University | 909-558-4908 | thamilton@llu.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020820 | Dyskinesias |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Placebo | Drug |
|
| 7 weeks |
subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.
Placebo
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous | years |
| Sex: Female, Male |
|
|
| 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. | Posted | 4 weeks |
|
|
| Secondary | Change in Dose of Anti-parkinsonian Medications | Posted | 7 weeks |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |