Trial Outcomes & Findings for Buspirone in Parkinson's Disease (NCT NCT02803749)
NCT ID: NCT02803749
Last Updated: 2020-01-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-01-02
Participant Flow
Participant milestones
| Measure |
Buspirone
Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.
Buspirone
|
Placebo
Flexible dosage placebo for 12 weeks.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
4
|
|
Overall Study
COMPLETED
|
12
|
4
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Buspirone in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Buspirone
n=17 Participants
Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.
Buspirone
|
Placebo
n=4 Participants
Flexible dosage placebo for 12 weeks.
Placebo
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
70.3 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
66.4 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
4 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Married participants
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Greater than high school education
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
History of Depression
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Taking Antidepressant or Anxiolytic
|
15 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Hoehn and Yahr Stage
1
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Hoehn and Yahr Stage
2
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Hoehn and Yahr Stage
3
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Hoehn and Yahr Stage
4
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
MDS-UPDRS
Total
|
59.6 units on a scale
STANDARD_DEVIATION 22.5 • n=5 Participants
|
67.5 units on a scale
STANDARD_DEVIATION 24.3 • n=7 Participants
|
61.1 units on a scale
STANDARD_DEVIATION 22.4 • n=5 Participants
|
|
MDS-UPDRS
nM-EDL
|
11.4 units on a scale
STANDARD_DEVIATION 5.2 • n=5 Participants
|
13 units on a scale
STANDARD_DEVIATION 5.2 • n=7 Participants
|
11.7 units on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
MDS-UPDRS
M-EDL
|
12.9 units on a scale
STANDARD_DEVIATION 7.6 • n=5 Participants
|
14.5 units on a scale
STANDARD_DEVIATION 7.5 • n=7 Participants
|
13.2 units on a scale
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
MDS-UPDRS
Motor
|
32.3 units on a scale
STANDARD_DEVIATION 15.3 • n=5 Participants
|
37.5 units on a scale
STANDARD_DEVIATION 11.7 • n=7 Participants
|
33.3 units on a scale
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
MDS-UPDRS
Motor Compications
|
3.0 units on a scale
STANDARD_DEVIATION 3.3 • n=5 Participants
|
3.3 units on a scale
STANDARD_DEVIATION 3.5 • n=7 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Unified Dyskinesia Rating Scale
|
5.2 units on a scale
STANDARD_DEVIATION 7.3 • n=5 Participants
|
3.8 units on a scale
STANDARD_DEVIATION 5.2 • n=7 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Parkinson Anxiety Scale
|
19.1 units on a scale
STANDARD_DEVIATION 3.9 • n=5 Participants
|
19.3 units on a scale
STANDARD_DEVIATION 5.1 • n=7 Participants
|
19.1 units on a scale
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Hamilton Anxiety Scale
|
11.4 units on a scale
STANDARD_DEVIATION 4 • n=5 Participants
|
12.3 units on a scale
STANDARD_DEVIATION 2.9 • n=7 Participants
|
11.5 units on a scale
STANDARD_DEVIATION 3.7 • n=5 Participants
|
|
Hospital Anxiety and Depression Scale - Anxiety
|
8.2 units on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
6.8 units on a scale
STANDARD_DEVIATION 3.1 • n=7 Participants
|
7.9 units on a scale
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Hospital Anxiety and Depression Scale - Depression
|
5.4 units on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 2.6 • n=7 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Montreal Cognitive Assessment
|
26.3 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
26.8 units on a scale
STANDARD_DEVIATION 2.1 • n=7 Participants
|
26.4 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Started Taking Antidepressant or Anxiolytic during Study
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Buspirone
n=17 Participants
Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.
Buspirone
|
Placebo
n=4 Participants
Flexible dosage placebo for 12 weeks.
Placebo
|
|---|---|---|
|
The Number of Participants Who Fail to Complete the 12-week Study on Study Drug.
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksThe HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety.
Outcome measures
| Measure |
Buspirone
n=12 Participants
Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.
Buspirone
|
Placebo
n=4 Participants
Flexible dosage placebo for 12 weeks.
Placebo
|
|---|---|---|
|
Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 12 Weeks
|
-4.21 score on a scale
Standard Error 1.13
|
-3.36 score on a scale
Standard Error 1.97
|
SECONDARY outcome
Timeframe: 12 weeksThe HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety.
Outcome measures
| Measure |
Buspirone
n=12 Participants
Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.
Buspirone
|
Placebo
n=4 Participants
Flexible dosage placebo for 12 weeks.
Placebo
|
|---|---|---|
|
Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks
|
9 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeksThe PGI-I assesses patient global impression of improvement on a 7-point scale where 1 = "very much improved" and 7 = "very much worse."
Outcome measures
| Measure |
Buspirone
n=12 Participants
Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.
Buspirone
|
Placebo
n=4 Participants
Flexible dosage placebo for 12 weeks.
Placebo
|
|---|---|---|
|
Number of "Much Improved" or "Very Much Improved" on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline to 12 weeksThe 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.
Outcome measures
| Measure |
Buspirone
n=12 Participants
Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.
Buspirone
|
Placebo
n=4 Participants
Flexible dosage placebo for 12 weeks.
Placebo
|
|---|---|---|
|
Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS)
|
-1.87 score on a scale
Standard Error 0.98
|
-0.89 score on a scale
Standard Error 1.71
|
SECONDARY outcome
Timeframe: 12 weeksThe UDysRS assesses dyskinesias on a scale of 0-104 where a higher score represents more severe dyskinesias.
Outcome measures
| Measure |
Buspirone
n=12 Participants
Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.
Buspirone
|
Placebo
n=4 Participants
Flexible dosage placebo for 12 weeks.
Placebo
|
|---|---|---|
|
Mean Change in Unified Dyskinesia Rating Scale (UDysRS) From Baseline to 12 Weeks
|
.72 score on a scale
Standard Error 3.22
|
7.78 score on a scale
Standard Error 6.44
|
SECONDARY outcome
Timeframe: 12 weeksThe CGI-I assesses clinician global impression of improvement on a 7-point scale where 1 = "very much improved" and 7 = "very much worse."
Outcome measures
| Measure |
Buspirone
n=12 Participants
Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.
Buspirone
|
Placebo
n=4 Participants
Flexible dosage placebo for 12 weeks.
Placebo
|
|---|---|---|
|
Number of "Much Improved" or "Very Much Improved" on Clinical Global Impressions-Improvement (CGI-I) at 12 Weeks
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 weeksThe 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.
Outcome measures
| Measure |
Buspirone
n=12 Participants
Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.
Buspirone
|
Placebo
n=4 Participants
Flexible dosage placebo for 12 weeks.
Placebo
|
|---|---|---|
|
Mean Change in Hospital Anxiety and Depression Scale (HADS) - Depression From Baseline to 12 Weeks
|
-.95 units on a scale
Standard Error .46
|
.34 units on a scale
Standard Error .81
|
Adverse Events
Buspirone
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Buspirone
n=17 participants at risk
Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.
Buspirone
|
Placebo
n=4 participants at risk
Flexible dosage placebo for 12 weeks.
Placebo
|
|---|---|---|
|
General disorders
Increased freezing of gait
|
29.4%
5/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
tremor
|
17.6%
3/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
sleep difficulties
|
11.8%
2/17 • 12 weeks
|
50.0%
2/4 • 12 weeks
|
|
General disorders
dizziness
|
11.8%
2/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
increased fatigue
|
11.8%
2/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
increased tremor
|
5.9%
1/17 • 12 weeks
|
75.0%
3/4 • 12 weeks
|
|
General disorders
balance impairment
|
5.9%
1/17 • 12 weeks
|
50.0%
2/4 • 12 weeks
|
|
General disorders
increased peripheral edema
|
5.9%
1/17 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/17 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
|
General disorders
Gait Difficulties
|
0.00%
0/17 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
|
General disorders
Vertigo
|
0.00%
0/17 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
|
Eye disorders
Vision Changes
|
0.00%
0/17 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
|
General disorders
Weakness
|
0.00%
0/17 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
|
General disorders
Bradycardia
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Constipation
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Dysphagia
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Fuzziness
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
Gastrointestinal disorders
Gastritis/Duodenitis
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
Gastrointestinal disorders
Gastrointestinal Illness
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Hand Cramps
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Headache
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Increased agitation
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Increased appetite
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Increased balance impairment
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Increased dystonia
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Increased irritability
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Increased Knee pain
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Increased OFF time
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
increased pain secondary to lipomas
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
insomnia
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
joint stiffness
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Left shoulder/neck pain
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
leg pain
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
nasal congestion
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
numbness
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection
|
5.9%
1/17 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place