A Phase 2 interventional study of Varenicline and Sugar pill in Parkinson Disease, sponsored by Rush University Medical Center. Completed at 1 site in United States. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-12-30.
Sponsored by Rush University Medical Center · Phase 2, Interventional, and Treatment
The purpose of this study is to determine if varenicline is effective in improving gait and balance impairment in patients with Parkinson disease.
Parkinson disease (PD) is a clinical entity characterized by bradykinesia, rigidity, tremor, and postural instability. Current treatments primarily focus on replacement of dopamine to compensate for the degeneration of the substantia nigra pars compacta dopaminergic neuronal population. Though dopamine treats many of the motor symptoms of PD, postural instability (which often leads to falls) typically is least responsive to therapy. More recently, the degeneration of the cholinergic system arising from the pedunculopontine nucleus (PPN) in the brainstem has been implicated in gait dysfunction in PD. Striatal cholinergic inputs are supplied from the PPN both via the intralaminar complex of the thalamus and through direct inputs. The primary subtypes of cholinergic receptors present in the striatum are nicotinic and include α4β2, α6β2, and α7 receptors. Varenicline (Chantix) is a novel partial α4β2 agonist and full α7 agonist developed as an aid for smoking cessation and has been shown in initial studies to improve imbalance in patients with inherited spinocerebellar ataxia. The unique method of action of varenicline may make it an ideal drug for the treatment of balance impairment in PD.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 40 is close to the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Varenicline
Drug: Sugar pill
Varenicline 1mg twice daily for eight weeks after a one week dose escalation period.
Also known as: Chantix
1mg twice daily for eight weeks after a one week dose escalation phase.
Berg Balance Scale
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.
Time frame: 9 weeks
Frontal Assessment Battery
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.
Time frame: 9 weeks
Mini Mental Status Exam (MMSE)
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.
Time frame: 9 weeks
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).
| Milestone | Varenicline | Sugar Pill |
|---|---|---|
| Started | 18 | 18 |
| Completed | 15 | 17 |
| Not completed | 3 | 1 |
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.
| score on a scale | Varenicline | Sugar Pill |
|---|---|---|
| Baseline | 43.93 ± 1.97 | 41.14 ± 2.55 |
| End Point | 43.25 ± 1.84 | 45.13 ± 2.34 |
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.
| score on a scale | Varenicline | Sugar Pill |
|---|---|---|
| Baseline | 17.40 ± 0.97 | 15.25 ± 2.77 |
| End point | 17.70 ± 2.16 | 15.19 ± 2.74 |
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.
| score on a scale | Varenicline | Sugar Pill |
|---|---|---|
| Baseline | 29.08 ± 1.17 | 28.19 ± 1.72 |
| End point | 28.00 ± 2.00 | 28.13 ± 1.7 |
Collected over Adverse events were collected throughout subject participation (e.g. 9 weeks).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Varenicline | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Sugar Pill | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
36 participants were randomized. Six participants terminated participation early with 2 having sufficient data for last observations carried forward. 32 were used in the analysis and demographics are reported here.
| Age, Categorical(Participants) | Varenicline | Sugar Pill | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 3 | 6 |
| >=65 years | 12 | 14 | 26 |
| Age, Continuous(years) | Varenicline | Sugar Pill | Total |
|---|---|---|---|
| Mean | 71.93 ± 8.5 | 70.24 ± 7.9 | 71.03 ± 8.134 |
| Sex: Female, Male(Participants) | Varenicline | Sugar Pill | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 12 | 14 | 26 |
| Race/Ethnicity, Customized(Participants) | Varenicline | Sugar Pill | Total |
|---|---|---|---|
| White | 15 | 17 | 32 |
| Region of Enrollment(participants) | Varenicline | Sugar Pill | Total |
|---|---|---|---|
| United States | 15 | 17 | 32 |
| Unified Parkinson's Disease Rating Scale(units on a scale) | Varenicline | Sugar Pill | Total |
|---|---|---|---|
| Mean | 33.1 ± 9.7 | 35.7 ± 12.7 | 34.74 ± 11.558 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rush University Medical Center