Buspirone in Parkinson's Disease

University of Rochester

Status and phase: Completed; Phase 2

Conditions: Parkinson Disease; Anxiety

Treatments: Drug: Buspirone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02803749

61141

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

21 participants in 2 patient groups, including a placebo group

Buspirone

Experimental group

Description:

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

Treatment:

Drug: Buspirone

Placebo

Placebo Comparator group

Description:

Flexible dosage placebo for 12 weeks.

Treatment:

Drug: Placebo