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Buspirone in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02803749
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : May 20, 2019
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Irene Richard, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Anxiety Drug: Buspirone Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Tolerability of Buspirone for the Treatment of Anxiety in Parkinson's Disease
Study Start Date : October 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Buspirone
Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.
Drug: Buspirone
Placebo Comparator: Placebo
Flexible dosage placebo for 12 weeks.
Drug: Placebo



Primary Outcome Measures :
  1. The proportion of participants who fail to complete the 12-week study on study drug. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Mean change in Hamilton Anxiety Rating Scale (HAM-A) from baseline to 12 weeks [ Time Frame: 12 weeks ]
    The HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety.

  2. Proportion of responders (>50% reduction from baseline or reduction to ≤7 on HAM-A) at 12 weeks [ Time Frame: 12 weeks ]
    The HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety.

  3. Proportion "much improved" or "very much improved" on Patient Global Impressions-Improvement (PGI-I) at 12 weeks [ Time Frame: 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."

  4. Mean change in Hospital Anxiety and Depression Scale (HADS) from baseline to 12 weeks [ Time Frame: 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.

  5. Mean change in Unified Dyskinesia Rating Scale (UDysRS) from baseline to 12 weeks [ Time Frame: 12 weeks ]
    The UDysRS assesses dyskinesias on a scale of 0-104 where a higher score represents more severe dyskinesias.

  6. Correlation of change in Parkinson Anxiety Scale score with change in Clinical Global Impressions-Improvement scale score. [ Time Frame: 12 weeks ]
    The Parkinson Anxiety Scale is a new self-rated anxiety scale. Sensitivity to change over time will be assessed by anchoring it against the CGI-I.

  7. Proportion "much improved" or "very much improved" on Clinical Global Impressions-Improvement (CGI-I) at 12 weeks [ Time Frame: 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."

  8. Correlation of change in Parkinson Anxiety Scale score with change in Patient Global Impressions-Improvement scale score. [ Time Frame: 12 weeks ]
    The Parkinson Anxiety Scale is a new self-rated anxiety scale. Sensitivity to change over time will be assessed by anchoring it against the PGI-I.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02803749


Locations
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United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14618
Sponsors and Collaborators
University of Rochester
Michael J. Fox Foundation for Parkinson's Research
Investigators
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Principal Investigator: Irene Richard, MD University of Rochester

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Responsible Party: Irene Richard, Professor of Neurology, University of Rochester
ClinicalTrials.gov Identifier: NCT02803749     History of Changes
Other Study ID Numbers: 61141
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Buspirone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action