Trial · NCT01341080
Varenicline for Gait and Balance Impairment in Parkinson Disease
NCT01341080, Phase 2, Completed, Rush University Medical Center; results first posted 2022-12-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Varenicline for Gait and Balance Impairment in Parkinson Disease. Trials, record NCT01341080. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01341080
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Varenicline for Gait and Balance Impairment in Parkinson Disease
- NCT number
- NCT01341080
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Rush University Medical Center
- Conditions
- Parkinson Disease
- Interventions
- Varenicline, Sugar pill
- First posted
- 2011-04-25
- Last updated
- 2022-12-30
- Results first posted
- 2022-12-30
- Limitations and caveats
The sensitivity of the BBS is poor to moderate, with frequent uncertainty in its scoring; The study also faced challenges in recruitment, which was slow and spanned 8 years, potentially biasing the sample; High attrition resulted in a smaller sample size than estimated by power analysis; Although the authors intended to recruit tremor predominant and PIGD patients in equal numbers, the PIGD subtype was overrepresented. Thus, the PIGD subtype was unintentionally favored.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Berg Balance Scale | 9 weeks | 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. |
| Secondary | Frontal Assessment Battery | 9 weeks | The 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. |
| Secondary | Mini Mental Status Exam (MMSE) | 9 weeks | The 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Berg Balance Scale | 9 weeks | score on a scale | MEAN | |
| SECONDARY | Frontal Assessment Battery | 9 weeks | score on a scale | MEAN | |
| SECONDARY | Mini Mental Status Exam (MMSE) | 9 weeks | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Berg Balance Scale | Varenicline | Baseline | 43.93 | Standard Deviation 1.97 | score on a scale |
| Berg Balance Scale | Sugar Pill | Baseline | 41.14 | Standard Deviation 2.55 | score on a scale |
| Berg Balance Scale | Varenicline | End Point | 43.25 | Standard Deviation 1.84 | score on a scale |
| Berg Balance Scale | Sugar Pill | End Point | 45.13 | Standard Deviation 2.34 | score on a scale |
| Frontal Assessment Battery | Varenicline | Baseline | 17.40 | Standard Deviation 0.97 | score on a scale |
| Frontal Assessment Battery | Sugar Pill | Baseline | 15.25 | Standard Deviation 2.77 | score on a scale |
| Frontal Assessment Battery | Varenicline | End point | 17.70 | Standard Deviation 2.16 | score on a scale |
| Frontal Assessment Battery | Sugar Pill | End point | 15.19 | Standard Deviation 2.74 | score on a scale |
| Mini Mental Status Exam (MMSE) | Varenicline | Baseline | 29.08 | Standard Deviation 1.17 | score on a scale |
| Mini Mental Status Exam (MMSE) | Sugar Pill | Baseline | 28.19 | Standard Deviation 1.72 | score on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Varenicline | 18 | |
| Overall Study | STARTED | Sugar Pill | 18 | |
| Overall Study | COMPLETED | Varenicline | 15 | |
| Overall Study | COMPLETED | Sugar Pill | 17 | |
| Overall Study | NOT COMPLETED | Varenicline | 3 | |
| Overall Study | NOT COMPLETED | Sugar Pill | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Varenicline | 0 | 18 |
| Total, all-cause mortality | Sugar Pill | 0 | 18 |
| Total, other adverse events | Varenicline | 0 | 18 |
| Total, other adverse events | Sugar Pill | 0 | 18 |
| Total, serious adverse events | Varenicline | 0 | 18 |
| Total, serious adverse events | Sugar Pill | 0 | 18 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Varenicline vs Sugar Pill: deaths from any cause | Trial comparisons |
| Varenicline vs Sugar Pill: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01341080
GET https://conductscience.org/api/trials/v1/NCT01341080/registered