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NCT01341080: Chantix-PD

Varenicline for Gait and Balance Impairment in Parkinson Disease

Completed Phase 2 Results posted Last updated 30 December 2022
What this trial tests

Phase 2 trial testing Varenicline in Parkinson Disease in 40 participants. Completed in 2 November 2018.

Timeline
28 December 2010
Primary endpoint
2 November 2018
2 November 2018

Quick facts

Lead sponsorRush University Medical Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment40
Start date28 December 2010
Primary completion2 November 2018
Estimated completion2 November 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Rush University Medical Center

Who can join

Adults 40 to 90, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Berg Balance Scale Primary · 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.

Baseline
GroupValue95% CI
Varenicline43.93± 1.97
Sugar Pill41.14± 2.55
End Point
GroupValue95% CI
Varenicline43.25± 1.84
Sugar Pill45.13± 2.34
Frontal Assessment Battery Secondary · 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.

Baseline
GroupValue95% CI
Varenicline17.40± 0.97
Sugar Pill15.25± 2.77
End point
GroupValue95% CI
Varenicline17.70± 2.16
Sugar Pill15.19± 2.74
Mini Mental Status Exam (MMSE) Secondary · 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.

Baseline
GroupValue95% CI
Varenicline29.08± 1.17
Sugar Pill28.19± 1.72
End point
GroupValue95% CI
Varenicline28.00± 2.00
Sugar Pill28.13± 1.7

Sponsor's own description

The purpose of this study is to determine if varenicline is effective in improving gait and balance impairment in patients with Parkinson disease.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Cognitive Impairment in Fall-Related Studies in Parkinson's Disease.
    Domingos JM, Godinho C, Dean J, Coelho M, et al · · 2015 · cited 32× · PMID 26406125 · DOI 10.3233/jpd-150590
  2. Chronic nicotine improves cognitive and social impairment in mice overexpressing wild type α-synuclein.
    Subramaniam SR, Magen I, Bove N, Zhu C, et al · · 2018 · cited 31× · PMID 29859873 · DOI 10.1016/j.nbd.2018.05.018
  3. Varenicline for the Treatment of Postural and Gait Dysfunction in Parkinson Disease.
    Kapur S, Vaughan C, Hawkins J, Stebbins G, et al · · 2021 · cited 4× · PMID 34992953 · DOI 10.1212/cpj.0000000000000958

Verify or expand the search:

Other trials of Varenicline

Trials testing the same drug.

Other recruiting trials for Parkinson Disease

Currently open trials in the same condition.

Other Rush University Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01341080.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing