Back to results

Buspirone in Parkinson's Disease

Primary Purpose

Parkinson Disease, Anxiety

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Buspirone

Placebo

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

Learn more about this trial

Buspirone in Parkinson's Disease

We'll reach out to this number within 24 hrs