Phase 2
N=21
Buspirone in Parkinson's Disease
Parkinson Disease · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT02803749 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: The Number of Participants Who Fail to Complete the 12-week Study on Study Drug. — 7; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Buspirone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants Who Fail to Complete the 12-week Study on Study Drug. |
7; 0 | — |
| SECONDARY Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 12 Weeks |
-4.21; -3.36 | — |
| SECONDARY Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks |
9; 1 | — |
| SECONDARY Number of "Much Improved" or "Very Much Improved" on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks |
3; 0 | — |
| SECONDARY Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS) |
-1.87; -0.89 | — |
| SECONDARY Mean Change in Unified Dyskinesia Rating Scale (UDysRS) From Baseline to 12 Weeks |
.72; 7.78 | — |
| SECONDARY Number of "Much Improved" or "Very Much Improved" on Clinical Global Impressions-Improvement (CGI-I) at 12 Weeks |
5; 2 | — |
| SECONDARY Mean Change in Hospital Anxiety and Depression Scale (HADS) - Depression From Baseline to 12 Weeks |
-.95; .34 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02803749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.