Buspirone in Parkinson's Disease
Primary Purpose
Parkinson Disease, Anxiety
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Buspirone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of idiopathic PD by UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
- Significant anxiety as determined by the self-rated Parkinson Anxiety Scale (score ≥ 14)
- Able to provide written informed consent
- At least 18 years of age
Exclusion Criteria:
- Diagnosis of atypical or secondary parkinsonism
- Concomitant treatment with an MAO inhibitor within the 14 days prior to screening visit
- Significant renal or hepatic impairment
- Significant cognitive impairment defined as MOCA score < 23
- On-going depression with suicidal or homicidal ideation and concern for patient safety based on clinical determination by the investigator
- Allergy or intolerance to study drug, matching placebo, or their formulations
- History of prior exposure to study drug
- Lactating or pregnant woman
- Concomitant treatment with a disallowed medication (detailed in section 6.2)
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- Concomitant treatment with an anxiolytic or antidepressant will be allowed however potential participants who had dosage changes in the 30 days prior to the screening visit will be excluded
- Use of an investigational drug within 30 days prior to screening visit
- Any medical or psychiatric comorbidity that, in the opinion of the investigator, would compromise study participation
- Dysphagia defined as a score of ≥ 2 on MDS-UPDRS Item 2.3 Chewing and Swallowing
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Buspirone
Placebo
Arm Description
Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.
Flexible dosage placebo for 12 weeks.
Outcomes
Primary Outcome Measures
The Number of Participants Who Fail to Complete the 12-week Study on Study Drug.
Secondary Outcome Measures
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.
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.
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."
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.
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.
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."
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.
Full Information
NCT ID
NCT02803749
First Posted
June 14, 2016
Last Updated
December 16, 2019
Sponsor
University of Rochester
Collaborators
Michael J. Fox Foundation for Parkinson's Research
1. Study Identification
Unique Protocol Identification Number
NCT02803749
Brief Title
Buspirone in Parkinson's Disease
Official Title
The Tolerability of Buspirone for the Treatment of Anxiety in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Michael J. Fox Foundation for Parkinson's Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Buspirone
Arm Type
Experimental
Arm Description
Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Flexible dosage placebo for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Buspirone
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The Number of Participants Who Fail to Complete the 12-week Study on Study Drug.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 12 Weeks
Description
The HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety.
Time Frame
12 weeks
Title
Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks
Description
The HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety.
Time Frame
12 weeks
Title
Number of "Much Improved" or "Very Much Improved" on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks
Description
The PGI-I assesses patient global impression of improvement on a 7-point scale where 1 = "very much improved" and 7 = "very much worse."
Time Frame
12 weeks
Title
Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
baseline to 12 weeks
Title
Mean Change in Unified Dyskinesia Rating Scale (UDysRS) From Baseline to 12 Weeks
Description
The UDysRS assesses dyskinesias on a scale of 0-104 where a higher score represents more severe dyskinesias.
Time Frame
12 weeks
Title
Number of "Much Improved" or "Very Much Improved" on Clinical Global Impressions-Improvement (CGI-I) at 12 Weeks
Description
The CGI-I assesses clinician global impression of improvement on a 7-point scale where 1 = "very much improved" and 7 = "very much worse."
Time Frame
12 weeks
Title
Mean Change in Hospital Anxiety and Depression Scale (HADS) - Depression From Baseline to 12 Weeks
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of idiopathic PD by UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
Significant anxiety as determined by the self-rated Parkinson Anxiety Scale (score ≥ 14)
Able to provide written informed consent
At least 18 years of age
Exclusion Criteria:
Diagnosis of atypical or secondary parkinsonism
Concomitant treatment with an MAO inhibitor within the 14 days prior to screening visit
Significant renal or hepatic impairment
Significant cognitive impairment defined as MOCA score < 23
On-going depression with suicidal or homicidal ideation and concern for patient safety based on clinical determination by the investigator
Allergy or intolerance to study drug, matching placebo, or their formulations
History of prior exposure to study drug
Lactating or pregnant woman
Concomitant treatment with a disallowed medication (detailed in section 6.2)
Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
Concomitant treatment with an anxiolytic or antidepressant will be allowed however potential participants who had dosage changes in the 30 days prior to the screening visit will be excluded
Use of an investigational drug within 30 days prior to screening visit
Any medical or psychiatric comorbidity that, in the opinion of the investigator, would compromise study participation
Dysphagia defined as a score of ≥ 2 on MDS-UPDRS Item 2.3 Chewing and Swallowing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Richard, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Buspirone in Parkinson's Disease
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