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| Name | Class |
|---|---|
| Michael J. Fox Foundation for Parkinson's Research | OTHER |
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Anxiety is highly prevalent in Parkinson's disease and negatively impacts quality of life yet it frequently remains untreated and there have been no clinical trials dedicated to evaluating the pharmacological treatment of anxiety in Parkinson's disease. Buspirone is effective for the treatment of generalized anxiety disorder in the general and elderly population. It is not known if it is effective for the treatment of anxiety in Parkinson's disease. This is a single-center, placebo-controlled, double-blind design with participants randomized with a 4:1 allocation ratio to flexible dosage buspirone (maximum dosage 30 mg twice daily) or placebo for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buspirone | Experimental | Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks. |
|
| Placebo | Placebo Comparator | Flexible dosage placebo for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buspirone | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Who Fail to Complete the 12-week Study on Study Drug. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 12 Weeks | The HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety. | 12 weeks |
| Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene Richard, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14618 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Buspirone | Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks. Buspirone |
| FG001 | Placebo | Flexible dosage placebo for 12 weeks. Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Buspirone | Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks. Buspirone |
| BG001 | Placebo | Flexible dosage placebo for 12 weeks. 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 | The Number of Participants Who Fail to Complete the 12-week Study on Study Drug. | Posted | Count of Participants | Participants | 12 weeks |
|
|
12 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 | Buspirone | Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks. Buspirone |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased freezing of gait | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ruth Schneider | University of Rochester | 584-341-7500 | ruth_schneider@urmc.rochester.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 | May 27, 2016 | Oct 2, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 9, 2016 | Dec 9, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D002065 | Buspirone |
| ID | Term |
|---|---|
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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|
The HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety. |
| 12 weeks |
| Number of "Much Improved" or "Very Much Improved" on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks | The PGI-I assesses patient global impression of improvement on a 7-point scale where 1 = "very much improved" and 7 = "very much worse." | 12 weeks |
| Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS) | The HADS assesses anxiety on a scale of 0-21 and depression on a scale of 0-21 with higher scores indicating higher levels of anxiety and depression respectively. | baseline to 12 weeks |
| Mean Change in Unified Dyskinesia Rating Scale (UDysRS) From Baseline to 12 Weeks | The UDysRS assesses dyskinesias on a scale of 0-104 where a higher score represents more severe dyskinesias. | 12 weeks |
| Number of "Much Improved" or "Very Much Improved" on Clinical Global Impressions-Improvement (CGI-I) at 12 Weeks | The CGI-I assesses clinician global impression of improvement on a 7-point scale where 1 = "very much improved" and 7 = "very much worse." | 12 weeks |
| Mean Change in Hospital Anxiety and Depression Scale (HADS) - Depression From Baseline to 12 Weeks | The HADS assesses anxiety on a scale of 0-21 and depression on a scale of 0-21 with higher scores indicating higher levels of anxiety and depression respectively. | 12 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Married participants | Count of Participants | Participants |
|
| Greater than high school education | Count of Participants | Participants |
|
| History of Depression | Count of Participants | Participants |
|
| Taking Antidepressant or Anxiolytic | Count of Participants | Participants |
|
| Hoehn and Yahr Stage | The Hoehn and Yahr scale defines broad categories of motor function in Parkinson's disease with a score of 1 indicating Unilateral involvement, a score of 2 indicating Bilateral involvement without balance impairment, a score of 3 indicating mild-moderate disability with balance impairment and a score of 4 indicating severe disability, still able to walk or stand unassisted. | Count of Participants | Participants |
|
| MDS-UPDRS | The Movement Disorder Society Unified Parkinson's Disease Rating scale evaluates aspects of motor and non-motor experiences of daily living. The scale assesses non-motor experiences of daily living (NM-EDL; range 0-52), motor experiences of daily living (M-EDL; range 0-52), motor examination ; range 0-132), and motor complications (range 0-24). Each subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Scores for sub scales are summed to create the Total score. The total range of scores is 0-260. Higher scores mean worse outcomes. | Mean | Standard Deviation | units on a scale |
|
| Unified Dyskinesia Rating Scale | The Unified Dyskinesia Rating Scale captures the essential features of dyskinesia in Parkinson's disease within a single scale, including patient perceptions, time factors, anatomical distribution, objective impairment, severity, and disability. A lower score is a better outcome for this measure. | Mean | Standard Deviation | units on a scale |
|
| Parkinson Anxiety Scale | The Parkinson's Anxiety Scale measures the anxiety of Participants on a scale of 0-48 with a lower score being a better outcome. | Mean | Standard Deviation | units on a scale |
|
| Hamilton Anxiety Scale | The Hamilton Anxiety Scale is used to measure the severity of anxiety symptoms. The scale ranges from 0-56 with a lower score being the desired outcome. | Mean | Standard Deviation | units on a scale |
|
| Hospital Anxiety and Depression Scale - Anxiety | The Hospital Anxiety and Depression Scale is a fourteen item scale consisting of seven depression and seven anxiety questions. The scores range from 0-42 (for 14 questions) and 0-21 for each subsection of anxiety and depression. For the purposes of this information, anxiety and depression scores are split up with this data showing anxiety results so the scale ranges from 0-21 with a low score being better. | Mean | Standard Deviation | units on a scale |
|
| Hospital Anxiety and Depression Scale - Depression | The Hospital Anxiety and Depression Scale is a fourteen item scale consisting of seven depression and seven anxiety questions. The scores range from 0-42 (for 14 questions) and 0-21 for each subsection of anxiety and depression For the purposes of this information, anxiety and depression scores are split up with this data showing depression results so the scale ranges from 0-21 with a low score being better. | Mean | Standard Deviation | units on a scale |
|
| Montreal Cognitive Assessment | The Montreal Cognitive Assessment (MoCA) measures cognitive capacity on a scale of 0-30 with a higher score being the better outcome. | Mean | Standard Deviation | units on a scale |
|
| Started Taking Antidepressant or Anxiolytic during Study | Count of Participants | Participants |
|
|
| Secondary | Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 12 Weeks | The HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety. | Posted | Mean | Standard Error | score on a scale | 12 weeks |
|
|
|
| Secondary | Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks | The HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Number of "Much Improved" or "Very Much Improved" on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks | The PGI-I assesses patient global impression of improvement on a 7-point scale where 1 = "very much improved" and 7 = "very much worse." | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS) | The HADS assesses anxiety on a scale of 0-21 and depression on a scale of 0-21 with higher scores indicating higher levels of anxiety and depression respectively. | Posted | Mean | Standard Error | score on a scale | baseline to 12 weeks |
|
|
|
| Secondary | Mean Change in Unified Dyskinesia Rating Scale (UDysRS) From Baseline to 12 Weeks | The UDysRS assesses dyskinesias on a scale of 0-104 where a higher score represents more severe dyskinesias. | Posted | Mean | Standard Error | score on a scale | 12 weeks |
|
|
|
| Secondary | Number of "Much Improved" or "Very Much Improved" on Clinical Global Impressions-Improvement (CGI-I) at 12 Weeks | The CGI-I assesses clinician global impression of improvement on a 7-point scale where 1 = "very much improved" and 7 = "very much worse." | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Mean Change in Hospital Anxiety and Depression Scale (HADS) - Depression From Baseline to 12 Weeks | The HADS assesses anxiety on a scale of 0-21 and depression on a scale of 0-21 with higher scores indicating higher levels of anxiety and depression respectively. | Posted | Mean | Standard Error | units on a scale | 12 weeks |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 5 |
| 17 |
| EG001 | Placebo | Flexible dosage placebo for 12 weeks. Placebo | 0 | 4 | 0 | 4 | 3 | 4 |
| tremor | General disorders | Systematic Assessment |
|
| sleep difficulties | General disorders | Systematic Assessment |
|
| dizziness | General disorders | Systematic Assessment |
|
| increased fatigue | General disorders | Systematic Assessment |
|
| increased tremor | General disorders | Systematic Assessment |
|
| balance impairment | General disorders | Systematic Assessment |
|
| increased peripheral edema | General disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Gait Difficulties | General disorders | Systematic Assessment |
|
| Vertigo | General disorders | Systematic Assessment |
|
| Vision Changes | Eye disorders | Systematic Assessment |
|
| Weakness | General disorders | Systematic Assessment |
|
| Bradycardia | General disorders | Systematic Assessment |
|
| Constipation | General disorders | Systematic Assessment |
|
| Dysphagia | General disorders | Systematic Assessment |
|
| Fuzziness | General disorders | Systematic Assessment |
|
| Gastritis/Duodenitis | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal Illness | Gastrointestinal disorders | Systematic Assessment |
|
| Hand Cramps | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Increased agitation | General disorders | Systematic Assessment |
|
| Increased appetite | General disorders | Systematic Assessment |
|
| Increased balance impairment | General disorders | Systematic Assessment |
|
| Increased dystonia | General disorders | Systematic Assessment |
|
| Increased irritability | General disorders | Systematic Assessment |
|
| Increased Knee pain | General disorders | Systematic Assessment |
|
| Increased OFF time | General disorders | Systematic Assessment |
|
| increased pain secondary to lipomas | General disorders | Systematic Assessment |
|
| insomnia | General disorders | Systematic Assessment |
|
| joint stiffness | General disorders | Systematic Assessment |
|
| Left shoulder/neck pain | General disorders | Systematic Assessment |
|
| leg pain | General disorders | Systematic Assessment |
|
| nasal congestion | General disorders | Systematic Assessment |
|
| numbness | General disorders | Systematic Assessment |
|
| Respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001523 | Mental Disorders |
| D010879 |
| Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D011083 | Polycyclic Compounds |