Buspirone in Parkinson's Disease

NCT ID: NCT02803749

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-01-25

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.

Conditions

Parkinson Disease; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Buspirone

Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.

Group Type: EXPERIMENTAL

Buspirone

Intervention Type: DRUG

Placebo

Flexible dosage placebo for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Buspirone

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michael J. Fox Foundation for Parkinson's Research

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Irene Richard

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Irene Richard, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

61141

Identifier Type: -

Identifier Source: org_study_id