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Buspirone in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02803749
Recruitment Status : Completed
First Posted : June 17, 2016
Results First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Irene Richard, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Parkinson Disease
Anxiety
Interventions Drug: Buspirone
Drug: Placebo
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Buspirone Placebo
Hide Arm/Group Description

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

Buspirone

Flexible dosage placebo for 12 weeks.

Placebo

Period Title: Overall Study
Started 17 4
Completed 12 4
Not Completed 5 0
Arm/Group Title Buspirone Placebo Total
Hide Arm/Group Description

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

Buspirone

Flexible dosage placebo for 12 weeks.

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 17 4 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 4 participants 21 participants
65.5  (9.8) 70.3  (10.6) 66.4  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 4 participants 21 participants
Female
4
  23.5%
3
  75.0%
7
  33.3%
Male
13
  76.5%
1
  25.0%
14
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 4 participants 21 participants
Hispanic or Latino
1
   5.9%
0
   0.0%
1
   4.8%
Not Hispanic or Latino
16
  94.1%
4
 100.0%
20
  95.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 4 participants 21 participants
17 4 21
Married participants  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 4 participants 21 participants
14
  82.4%
4
 100.0%
18
  85.7%
Greater than high school education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 4 participants 21 participants
14
  82.4%
4
 100.0%
18
  85.7%
History of Depression  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 4 participants 21 participants
2
  11.8%
1
  25.0%
3
  14.3%
Taking Antidepressant or Anxiolytic  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 4 participants 21 participants
15
  88.2%
2
  50.0%
17
  81.0%
Hoehn and Yahr Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 4 participants 21 participants
1
3
  17.6%
0
   0.0%
3
  14.3%
2
11
  64.7%
3
  75.0%
14
  66.7%
3
3
  17.6%
0
   0.0%
3
  14.3%
4
0
   0.0%
1
  25.0%
1
   4.8%
[1]
Measure Description: The Hoehn and Yahr scale defines broad categories of motor function in Parkinson's disease with a score of 1 indicating Unilateral involvement, a score of 2 indicating Bilateral involvement without balance impairment, a score of 3 indicating mild-moderate disability with balance impairment and a score of 4 indicating severe disability, still able to walk or stand unassisted.
MDS-UPDRS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 4 participants 21 participants
Total 59.6  (22.5) 67.5  (24.3) 61.1  (22.4)
nM-EDL 11.4  (5.2) 13  (5.2) 11.7  (5.1)
M-EDL 12.9  (7.6) 14.5  (7.5) 13.2  (7.4)
Motor 32.3  (15.3) 37.5  (11.7) 33.3  (14.5)
Motor Compications 3.0  (3.3) 3.3  (3.5) 3.1  (3.2)
[1]
Measure Description: The Movement Disorder Society Unified Parkinson's Disease Rating scale evaluates aspects of motor and non-motor experiences of daily living. The scale assesses non-motor experiences of daily living (NM-EDL; range 0-52), motor experiences of daily living (M-EDL; range 0-52), motor examination ; range 0-132), and motor complications (range 0-24). Each subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Scores for sub scales are summed to create the Total score. The total range of scores is 0-260. Higher scores mean worse outcomes.
Unified Dyskinesia Rating Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 4 participants 21 participants
5.2  (7.3) 3.8  (5.2) 5.0  (6.9)
[1]
Measure Description: The Unified Dyskinesia Rating Scale captures the essential features of dyskinesia in Parkinson's disease within a single scale, including patient perceptions, time factors, anatomical distribution, objective impairment, severity, and disability. A lower score is a better outcome for this measure.
Parkinson Anxiety Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 4 participants 21 participants
19.1  (3.9) 19.3  (5.1) 19.1  (4.0)
[1]
Measure Description: The Parkinson's Anxiety Scale measures the anxiety of Participants on a scale of 0-48 with a lower score being a better outcome.
Hamilton Anxiety Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 4 participants 21 participants
11.4  (4) 12.3  (2.9) 11.5  (3.7)
[1]
Measure Description: The Hamilton Anxiety Scale is used to measure the severity of anxiety symptoms. The scale ranges from 0-56 with a lower score being the desired outcome.
Hospital Anxiety and Depression Scale - Anxiety   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 4 participants 21 participants
8.2  (3.1) 6.8  (3.1) 7.9  (3.0)
[1]
Measure Description: The Hospital Anxiety and Depression Scale is a fourteen item scale consisting of seven depression and seven anxiety questions. The scores range from 0-42 (for 14 questions) and 0-21 for each subsection of anxiety and depression. For the purposes of this information, anxiety and depression scores are split up with this data showing anxiety results so the scale ranges from 0-21 with a low score being better.
Hospital Anxiety and Depression Scale - Depression   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 4 participants 21 participants
5.4  (3.1) 4.8  (2.6) 5.2  (3.0)
[1]
Measure Description: The Hospital Anxiety and Depression Scale is a fourteen item scale consisting of seven depression and seven anxiety questions. The scores range from 0-42 (for 14 questions) and 0-21 for each subsection of anxiety and depression For the purposes of this information, anxiety and depression scores are split up with this data showing depression results so the scale ranges from 0-21 with a low score being better.
Montreal Cognitive Assessment   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 4 participants 21 participants
26.3  (2.3) 26.8  (2.1) 26.4  (2.2)
[1]
Measure Description: The Montreal Cognitive Assessment (MoCA) measures cognitive capacity on a scale of 0-30 with a higher score being the better outcome.
Started Taking Antidepressant or Anxiolytic during Study  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 4 participants 21 participants
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title The Number of Participants Who Fail to Complete the 12-week Study on Study Drug.
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buspirone Placebo
Hide Arm/Group Description:

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

Buspirone

Flexible dosage placebo for 12 weeks.

Placebo

Overall Number of Participants Analyzed 17 4
Measure Type: Count of Participants
Unit of Measure: Participants
7
  41.2%
0
   0.0%
2.Secondary Outcome
Title Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 12 Weeks
Hide Description The HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buspirone Placebo
Hide Arm/Group Description:

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

Buspirone

Flexible dosage placebo for 12 weeks.

Placebo

Overall Number of Participants Analyzed 12 4
Mean (Standard Error)
Unit of Measure: score on a scale
-4.21  (1.13) -3.36  (1.97)
3.Secondary Outcome
Title Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks
Hide Description The HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buspirone Placebo
Hide Arm/Group Description:

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

Buspirone

Flexible dosage placebo for 12 weeks.

Placebo

Overall Number of Participants Analyzed 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
9
  75.0%
1
  25.0%
4.Secondary Outcome
Title Number of "Much Improved" or "Very Much Improved" on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks
Hide Description The PGI-I assesses patient global impression of improvement on a 7-point scale where 1 = "very much improved" and 7 = "very much worse."
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buspirone Placebo
Hide Arm/Group Description:

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

Buspirone

Flexible dosage placebo for 12 weeks.

Placebo

Overall Number of Participants Analyzed 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
3
  25.0%
0
   0.0%
5.Secondary Outcome
Title Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS)
Hide Description 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.
Time Frame baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buspirone Placebo
Hide Arm/Group Description:

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

Buspirone

Flexible dosage placebo for 12 weeks.

Placebo

Overall Number of Participants Analyzed 12 4
Mean (Standard Error)
Unit of Measure: score on a scale
-1.87  (0.98) -0.89  (1.71)
6.Secondary Outcome
Title Mean Change in Unified Dyskinesia Rating Scale (UDysRS) From Baseline to 12 Weeks
Hide Description The UDysRS assesses dyskinesias on a scale of 0-104 where a higher score represents more severe dyskinesias.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buspirone Placebo
Hide Arm/Group Description:

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

Buspirone

Flexible dosage placebo for 12 weeks.

Placebo

Overall Number of Participants Analyzed 12 4
Mean (Standard Error)
Unit of Measure: score on a scale
.72  (3.22) 7.78  (6.44)
7.Secondary Outcome
Title Number of "Much Improved" or "Very Much Improved" on Clinical Global Impressions-Improvement (CGI-I) at 12 Weeks
Hide Description The CGI-I assesses clinician global impression of improvement on a 7-point scale where 1 = "very much improved" and 7 = "very much worse."
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buspirone Placebo
Hide Arm/Group Description:

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

Buspirone

Flexible dosage placebo for 12 weeks.

Placebo

Overall Number of Participants Analyzed 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
5
  41.7%
2
  50.0%
8.Secondary Outcome
Title Mean Change in Hospital Anxiety and Depression Scale (HADS) - Depression From Baseline to 12 Weeks
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buspirone Placebo
Hide Arm/Group Description:

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

Buspirone

Flexible dosage placebo for 12 weeks.

Placebo

Overall Number of Participants Analyzed 12 4
Mean (Standard Error)
Unit of Measure: units on a scale
-.95  (.46) .34  (.81)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Buspirone Placebo
Hide Arm/Group Description

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

Buspirone

Flexible dosage placebo for 12 weeks.

Placebo

All-Cause Mortality
Buspirone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/4 (0.00%) 
Hide Serious Adverse Events
Buspirone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Buspirone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   5/17 (29.41%)   3/4 (75.00%) 
Eye disorders     
Vision Changes   0/17 (0.00%)  1/4 (25.00%) 
Gastrointestinal disorders     
Gastritis/Duodenitis   1/17 (5.88%)  0/4 (0.00%) 
Gastrointestinal Illness   1/17 (5.88%)  0/4 (0.00%) 
General disorders     
Increased freezing of gait   5/17 (29.41%)  0/4 (0.00%) 
tremor   3/17 (17.65%)  0/4 (0.00%) 
sleep difficulties   2/17 (11.76%)  2/4 (50.00%) 
dizziness   2/17 (11.76%)  0/4 (0.00%) 
increased fatigue   2/17 (11.76%)  0/4 (0.00%) 
increased tremor   1/17 (5.88%)  3/4 (75.00%) 
balance impairment   1/17 (5.88%)  2/4 (50.00%) 
increased peripheral edema   1/17 (5.88%)  1/4 (25.00%) 
Gait Difficulties   0/17 (0.00%)  1/4 (25.00%) 
Vertigo   0/17 (0.00%)  1/4 (25.00%) 
Weakness   0/17 (0.00%)  1/4 (25.00%) 
Bradycardia   1/17 (5.88%)  0/4 (0.00%) 
Constipation   1/17 (5.88%)  0/4 (0.00%) 
Dysphagia   1/17 (5.88%)  0/4 (0.00%) 
Fuzziness   1/17 (5.88%)  0/4 (0.00%) 
Hand Cramps   1/17 (5.88%)  0/4 (0.00%) 
Headache   1/17 (5.88%)  0/4 (0.00%) 
Increased agitation   1/17 (5.88%)  0/4 (0.00%) 
Increased appetite   1/17 (5.88%)  0/4 (0.00%) 
Increased balance impairment   1/17 (5.88%)  0/4 (0.00%) 
Increased dystonia   1/17 (5.88%)  0/4 (0.00%) 
Increased irritability   1/17 (5.88%)  0/4 (0.00%) 
Increased Knee pain   1/17 (5.88%)  0/4 (0.00%) 
Increased OFF time   1/17 (5.88%)  0/4 (0.00%) 
increased pain secondary to lipomas   1/17 (5.88%)  0/4 (0.00%) 
insomnia   1/17 (5.88%)  0/4 (0.00%) 
joint stiffness   1/17 (5.88%)  0/4 (0.00%) 
Left shoulder/neck pain   1/17 (5.88%)  0/4 (0.00%) 
leg pain   1/17 (5.88%)  0/4 (0.00%) 
nasal congestion   1/17 (5.88%)  0/4 (0.00%) 
numbness   1/17 (5.88%)  0/4 (0.00%) 
Injury, poisoning and procedural complications     
Fall   0/17 (0.00%)  1/4 (25.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory infection   1/17 (5.88%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash   1/17 (5.88%)  1/4 (25.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ruth Schneider
Organization: University of Rochester
Phone: 584-341-7500
EMail: ruth_schneider@urmc.rochester.edu
Layout table for additonal information
Responsible Party: Irene Richard, University of Rochester
ClinicalTrials.gov Identifier: NCT02803749    
Other Study ID Numbers: 61141
First Submitted: June 14, 2016
First Posted: June 17, 2016
Results First Submitted: October 4, 2019
Results First Posted: January 2, 2020
Last Update Posted: January 2, 2020