Trial Outcomes & Findings for Varenicline for Gait and Balance Impairment in Parkinson Disease (NCT NCT01341080)
NCT ID: NCT01341080
Last Updated: 2022-12-30
Results Overview
Efficacy was measured as a change on the Berg Balance Scale (BBS) from baseline to the end of the study after 8 weeks on drug. The BBS is a 14-item measure consisting of basic balance tasks, with a final score indicative of overall balance ability. The maximum score is 56 and minimum is 0. Higher scores reflect better balance.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
9 weeks
Results posted on
2022-12-30
Participant Flow
Subjects were recruitment from the Parkinson's Disease and Movement Disorder clinic at Rush University Medical Center over the course of the study (2011-2018).
40 participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining 32 were used in the analysis.
Participant milestones
| Measure |
Varenicline
Varenicline: Varenicline 1mg twice daily for eight weeks after a one week dose escalation period.
|
Sugar Pill
Sugar pill: 1mg twice daily for eight weeks after a one week dose escalation phase.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
Baseline characteristics by cohort
| Measure |
Varenicline
n=18 Participants
Varenicline: Varenicline 1mg twice daily for eight weeks after a one week dose escalation period.
|
Sugar Pill
n=18 Participants
Sugar pill: 1mg twice daily for eight weeks after a one week dose escalation phase.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
0 Participants
n=17 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
0 Participants
n=32 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=15 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
3 Participants
n=17 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
6 Participants
n=32 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
|
Age, Categorical
>=65 years
|
12 Participants
n=15 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
14 Participants
n=17 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
26 Participants
n=32 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
|
Age, Continuous
|
71.93 years
STANDARD_DEVIATION 8.5 • n=15 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
70.24 years
STANDARD_DEVIATION 7.9 • n=17 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
71.03 years
STANDARD_DEVIATION 8.134 • n=32 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
|
Sex: Female, Male
Female
|
3 Participants
n=15 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
3 Participants
n=17 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
6 Participants
n=32 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
|
Sex: Female, Male
Male
|
12 Participants
n=15 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
14 Participants
n=17 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
26 Participants
n=32 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=15 Participants • 36 participants were randomized and six participants terminated early. 2 had sufficient data for last observations carried forward. The remaining sample of 32 was used in the analysis.
|
17 Participants
n=17 Participants • 36 participants were randomized and six participants terminated early. 2 had sufficient data for last observations carried forward. The remaining sample of 32 was used in the analysis.
|
32 Participants
n=32 Participants • 36 participants were randomized and six participants terminated early. 2 had sufficient data for last observations carried forward. The remaining sample of 32 was used in the analysis.
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
17 participants
n=17 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
32 participants
n=32 Participants • Forty participants signed an informed consent form and 36 were randomized. Six participants terminated participation early, with 2 having sufficient data for last observations carried forward intention-to-treat analyses. The remaining sample was 32 participants.Fifteen participants were randomized to receive varenicline and 17 to placebo.
|
|
Unified Parkinson's Disease Rating Scale
|
33.1 units on a scale
STANDARD_DEVIATION 9.7 • n=18 Participants
|
35.7 units on a scale
STANDARD_DEVIATION 12.7 • n=18 Participants
|
34.74 units on a scale
STANDARD_DEVIATION 11.558 • n=36 Participants
|
PRIMARY outcome
Timeframe: 9 weeksEfficacy was measured as a change on the Berg Balance Scale (BBS) from baseline to the end of the study after 8 weeks on drug. The BBS is a 14-item measure consisting of basic balance tasks, with a final score indicative of overall balance ability. The maximum score is 56 and minimum is 0. Higher scores reflect better balance.
Outcome measures
| Measure |
Varenicline
n=15 Participants
Varenicline: Varenicline 1mg twice daily for eight weeks after a one week dose escalation period.
|
Sugar Pill
n=17 Participants
Sugar pill: 1mg twice daily for eight weeks after a one week dose escalation phase.
|
|---|---|---|
|
Berg Balance Scale
Baseline
|
43.93 score on a scale
Standard Deviation 1.97
|
41.14 score on a scale
Standard Deviation 2.55
|
|
Berg Balance Scale
End Point
|
43.25 score on a scale
Standard Deviation 1.84
|
45.13 score on a scale
Standard Deviation 2.34
|
SECONDARY outcome
Timeframe: 9 weeksThe change in cognitive functioning was measured with the Frontal Assessment Battery (FAB, score range 0-18) and the Mini-Mental State Exam (MMSE, score range 0-30) from baseline to 8 weeks on drug. High scores on both scales indicate better performance. The FAB measures executive functioning and consists of the following 6 sections: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy.
Outcome measures
| Measure |
Varenicline
n=15 Participants
Varenicline: Varenicline 1mg twice daily for eight weeks after a one week dose escalation period.
|
Sugar Pill
n=17 Participants
Sugar pill: 1mg twice daily for eight weeks after a one week dose escalation phase.
|
|---|---|---|
|
Frontal Assessment Battery
End point
|
17.70 score on a scale
Standard Deviation 2.16
|
15.19 score on a scale
Standard Deviation 2.74
|
|
Frontal Assessment Battery
Baseline
|
17.40 score on a scale
Standard Deviation 0.97
|
15.25 score on a scale
Standard Deviation 2.77
|
SECONDARY outcome
Timeframe: 9 weeksThe change in cognitive functioning was measured with the Mini-Mental State Exam (MMSE) from baseline to 8 weeks on drug. The maximum score on the MMSE is 30 and lowest score 0, with higher score indicating better cognitive function.
Outcome measures
| Measure |
Varenicline
n=15 Participants
Varenicline: Varenicline 1mg twice daily for eight weeks after a one week dose escalation period.
|
Sugar Pill
n=17 Participants
Sugar pill: 1mg twice daily for eight weeks after a one week dose escalation phase.
|
|---|---|---|
|
Mini Mental Status Exam (MMSE)
End point
|
28.00 score on a scale
Standard Deviation 2.00
|
28.13 score on a scale
Standard Deviation 1.7
|
|
Mini Mental Status Exam (MMSE)
Baseline
|
29.08 score on a scale
Standard Deviation 1.17
|
28.19 score on a scale
Standard Deviation 1.72
|
Adverse Events
Varenicline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place