Buspirone in Parkinson's Disease

NCT02803749 | Completed Phase 2 Results

• 1 other identifier: 61141
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The Number of Participants Who Fail to Complete the 12-week Study on Study Drug.

  12 weeks

Secondary Outcomes (7)

• Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 12 Weeks

  12 weeks

• Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks

  12 weeks

• Number of "Much Improved" or "Very Much Improved" on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks

  12 weeks

• Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS)

  baseline to 12 weeks

• Mean Change in Unified Dyskinesia Rating Scale (UDysRS) From Baseline to 12 Weeks

  12 weeks

Study Arms (2)

Buspirone

EXPERIMENTAL

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

Drug: Buspirone

Placebo

PLACEBO COMPARATOR

Flexible dosage placebo for 12 weeks.

Drug: Placebo

Interventions

Buspirone DRUG

Buspirone

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14618, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Anxiety Disorders

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Ruth Schneider
• Organization: University of Rochester

ruth_schneider@urmc.rochester.edu

584-341-7500

Study Officials

• Irene Richard, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 17, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 25, 2019
• Last Updated: January 2, 2020
• Results First Posted: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)