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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

Tracking Information
First Submitted Date  ICMJE June 14, 2016
First Posted Date  ICMJE June 17, 2016
Last Update Posted Date May 20, 2019
Study Start Date  ICMJE October 2016
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
The proportion of participants who fail to complete the 12-week study on study drug. [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02803749 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • 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.
  • 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.
  • 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."
  • 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.
  • 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.
  • 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.
  • 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."
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Buspirone in Parkinson's Disease
Official Title  ICMJE The Tolerability of Buspirone for the Treatment of Anxiety in Parkinson's Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Parkinson Disease
  • Anxiety
Intervention  ICMJE
  • Drug: Buspirone
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Buspirone
    Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.
    Intervention: Drug: Buspirone
  • Placebo Comparator: Placebo
    Flexible dosage placebo for 12 weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 17, 2019)
21
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2016)
27
Actual Study Completion Date  ICMJE January 25, 2019
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02803749
Other Study ID Numbers  ICMJE 61141
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Irene Richard, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE Michael J. Fox Foundation for Parkinson's Research
Investigators  ICMJE
Principal Investigator: Irene Richard, MD University of Rochester
PRS Account University of Rochester
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP