Buspirone in Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02803749
• Date of registration: 14/06/2016
• Prospective Registration: Yes
• Primary sponsor: University of Rochester
• Public title: Buspirone in Parkinson's Disease
• Scientific title: The Tolerability of Buspirone for the Treatment of Anxiety in Parkinson's Disease
• Date of first enrolment: October 2016
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02803749
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Irene Richard, MD
• Affiliation: University of Rochester

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Anxiety

Parkinson Disease

Intervention(s)

Drug: Buspirone

Drug: Placebo

Primary Outcome(s)

The Number of Participants Who Fail to Complete the 12-week Study on Study Drug. [Time Frame: 12 weeks]

Secondary Outcome(s)

Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 12 Weeks [Time Frame: 12 weeks]

Mean Change in Hospital Anxiety and Depression Scale (HADS) - Depression From Baseline to 12 Weeks [Time Frame: 12 weeks]

Number of "Much Improved" or "Very Much Improved" on Clinical Global Impressions-Improvement (CGI-I) at 12 Weeks [Time Frame: 12 weeks]

Mean Change in Unified Dyskinesia Rating Scale (UDysRS) From Baseline to 12 Weeks [Time Frame: 12 weeks]

Number of Responders (>50% Reduction From Baseline or Reduction to =7 on HAM-A) at 12 Weeks [Time Frame: 12 weeks]

Number of "Much Improved" or "Very Much Improved" on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks [Time Frame: 12 weeks]

Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS) [Time Frame: baseline to 12 weeks]

Secondary ID(s)

61141

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Michael J. Fox Foundation for Parkinson's Research

Results

• Results available: Yes
• Date Posted: 02/01/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02803749