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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23AG044441-01A1 | U.S. NIH Grant/Contract | View source |
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Funding cycle completed
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This study will evaluate the effectiveness of the rotigotine transdermal patch in reducing anxiety in people with Parkinson's disease.
Anxiety is a serious medical condition that worsens quality of life by negatively affecting peoples thoughts, feelings, and ability to function normally. Anxiety can affect anyone, but people with Parkinson's appear to be at a much higher risk with an estimated 40% or more suffering from anxiety. Parkinson's is a neurological disorder that causes tremor and other problems with normal movements. The disease symptoms are believed to be caused in large part by the loss of dopamine producing cells in the midbrain. Anxiety in Parkinson's may be associated with the loss of dopamine caused by the disease and therefore may respond to dopamine based treatments. This study will evaluate the effectiveness of the rotigotine transdermal patch, a dopamine replacement medication, in reducing symptoms of anxiety in people with Parkinson's disease.
Participants in this double-blind study will be randomly assigned to receive either rotigotine or a placebo patch for 8-weeks. All participants will be evaluated at the study site at baseline and weeks 2, 4, and 8. Psychiatric, cognitive, and movement assessments will be performed along with a review of anxiety symptoms. All participants will be offered continued routine psychiatric care with the study physician upon completion of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rotigotine | Active Comparator | rotigotine transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks |
|
| placebo | Placebo Comparator | placebo transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rotigotine transdermal patch | Drug | Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale | The main outcome measure for this study was change in anxiety symptom severity over the course of the study. Anxiety severity was measured using the Hamilton Anxiety Rating Scale (HARS).The HARS is a 14-item questionnaire, with each item assigned a score ranging from 0 ("not present") to 4 ("severe"). The total score of this scale ranges from 0 to 56, with scores greater than 17 indicating mild severity, scores between 18 and 24 indicating mild to moderate severity and scores greater than 25 indicating moderate to severe severity. | Baseline, weeks 2, 4 and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale | The main outcome measure for this study was change in depression symptom severity over the course of the study. Depression severity was measured using the Hamilton Depression Rating Scale (HAMD). The HAMD is a 17-item questionnaire, with each item assigned a score ranging from 0 ("not present") to 4 ("severe"). The total score of this scale ranges from 0 to 68, with scores greater than 7 indicating mild depressive symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Pontone, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rotigotine | rotigotine transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks rotigotine transdermal patch: Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily |
| FG001 | Placebo | placebo transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks placebo: Participants will receive a placebo transdermal patch to be worn daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rotigotine | rotigotine transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks rotigotine transdermal patch: Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale | The main outcome measure for this study was change in anxiety symptom severity over the course of the study. Anxiety severity was measured using the Hamilton Anxiety Rating Scale (HARS).The HARS is a 14-item questionnaire, with each item assigned a score ranging from 0 ("not present") to 4 ("severe"). The total score of this scale ranges from 0 to 56, with scores greater than 17 indicating mild severity, scores between 18 and 24 indicating mild to moderate severity and scores greater than 25 indicating moderate to severe severity. | Posted | Mean | Standard Deviation | score on a scale | Baseline, weeks 2, 4 and 8 |
|
Adverse event data were collected during the course of the study. This spanned from baseline through the tapering period for the drug (up to 42 days after the final study visit).
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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 | Rotigotine | rotigotine transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks rotigotine transdermal patch: Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Excessive Somnolence | General disorders | Systematic Assessment | Mild severity recovered without treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gregory Pontone | Johns Hopkins University School of Medicine | (410) 502 - 0477 | gpontone@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 26, 2017 | Mar 5, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| C047508 | rotigotine |
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| placebo | Drug | Participants will receive a placebo transdermal patch to be worn daily |
|
|
| Baseline, weeks 2, 4 and 8 |
placebo transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks placebo: Participants will receive a placebo transdermal patch to be worn daily |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants with Depression at baseline | The measure reports participants who were found to have depression (score > 7) at baseline per The Hamilton Depression Rating Scale (HAMD). The HAMD is a 17-item questionnaire, with each item assigned a score ranging from 0 ("not present") to 4 ("severe"). The total score of this scale ranges from 0 to 68, with scores greater than 7 indicating mild depressive symptoms. | Count of Participants | Participants |
|
| OG001 | Placebo | placebo transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks placebo: Participants will receive a placebo transdermal patch to be worn daily |
|
|
| Secondary | Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale | The main outcome measure for this study was change in depression symptom severity over the course of the study. Depression severity was measured using the Hamilton Depression Rating Scale (HAMD). The HAMD is a 17-item questionnaire, with each item assigned a score ranging from 0 ("not present") to 4 ("severe"). The total score of this scale ranges from 0 to 68, with scores greater than 7 indicating mild depressive symptoms. | Posted | Mean | Standard Deviation | score on a scale | Baseline, weeks 2, 4 and 8 |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Placebo | placebo transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks placebo: Participants will receive a placebo transdermal patch to be worn daily | 0 | 3 | 0 | 3 | 1 | 3 |
|
| Hallucinations | Psychiatric disorders | Systematic Assessment | mild severity, not distressing |
|
| Edema | Cardiac disorders | Systematic Assessment | mild severity |
|
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| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Week 4 |
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| Week 8 |
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