Varenicline for Gait and Balance Impairment in Parkinson Disease

NCT01341080 | Completed Phase 2 Results DMC

• 1 other identifier: WS813511
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Keywords

Balance; Postural impairment; Falls; Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  9 weeks

Secondary Outcomes (2)

• Frontal Assessment Battery

  9 weeks

• Mini Mental Status Exam (MMSE)

  9 weeks

Study Arms (2)

Varenicline

EXPERIMENTAL

Drug: Varenicline

Sugar pill

PLACEBO COMPARATOR

Drug: Sugar pill

Interventions

Varenicline DRUG

Varenicline 1mg twice daily for eight weeks after a one week dose escalation period.

Also known as: Chantix

Varenicline

Sugar pill DRUG

1mg twice daily for eight weeks after a one week dose escalation phase.

Sugar pill

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be diagnosed with Parkinson Disease (PD) by the United Kingdom (UK) Brain Bank criteria.
• Subjects will have to be at least stage 2 on the Hoehn and Yahr staging system of PD and have a history of at least 1 fall or near fall in the last 6 months
• Subjects must have a stable medication regimen.
• All subjects will be over the age of 40 in an attempt to exclude inherited forms of parkinsonism.
• Serum creatine kinase, complete metabolic panel, complete blood count, liver function tests, renal function tests, platelets and EKG are within normal limits (results obtained from primary care physician and dated within the past 6 months or obtained at screening visit).

You may not qualify if:

• Hoehn and Yahr stage V subjects.
• Subjects with a history of major psychiatric disorder, deep brain stimulation surgery, recent cerebral trauma, cardiac arrhythmia, or renal insufficiency.
• Concurrent treatment with any monoamine oxidase inhibitors (MAOIs), bupropion (Wellbutrin), or nicotine patches.
• Dementia or other psychiatric illness that prevents the patient from giving informed consent (Folstein Mini Mental Status Exam score less than 25).
• Concurrent treatment with trihexyphenidyl (Artane) or benztropine mesylate (Cogentin).
• Significant degree of dysphagia, by history.
• Legal incapacity or limited legal capacity.
• Presence of severe renal disease (BUN 50% greater than normal or creatinine clearance \<60 mL/min) or hepatic disease.
• Abnormal creatine kinase and/or platelet count in the past 6 months (as determined by lab reports obtained from primary care physicians or conducted at baseline).
• Use of varenicline within the previous 30 days.
• Women of childbearing potential who are pregnant at the time of screening or who will not use adequate protection during participation of the study.
• Allergy/sensitivity to the drug or its formulations.
• Concurrent participation in another clinical study.
• Active substance or tobacco use or dependence.
• Moderate or severe chronic obstructive pulmonary disease.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (6)

• Bohnen NI, Muller ML, Koeppe RA, Studenski SA, Kilbourn MA, Frey KA, Albin RL. History of falls in Parkinson disease is associated with reduced cholinergic activity. Neurology. 2009 Nov 17;73(20):1670-6. doi: 10.1212/WNL.0b013e3181c1ded6.

  PMID: 19917989 BACKGROUND

• Qutubuddin AA, Pegg PO, Cifu DX, Brown R, McNamee S, Carne W. Validating the Berg Balance Scale for patients with Parkinson's disease: a key to rehabilitation evaluation. Arch Phys Med Rehabil. 2005 Apr;86(4):789-92. doi: 10.1016/j.apmr.2004.11.005.

  PMID: 15827933 BACKGROUND

• Zesiewicz TA, Sullivan KL. Treatment of ataxia and imbalance with varenicline (chantix): report of 2 patients with spinocerebellar ataxia (types 3 and 14). Clin Neuropharmacol. 2008 Nov-Dec;31(6):363-5. doi: 10.1097/WNF.0b013e31818736a9.

  PMID: 19050414 BACKGROUND

• Perez XA, Quik M. Focus on alpha4beta2* and alpha6beta2* nAChRs for Parkinson's Disease Therapeutics. Mol Cell Pharmacol. 2011;3(1):1-6.

  PMID: 21499569 BACKGROUND

• Bohnen NI, Albin RL. The cholinergic system and Parkinson disease. Behav Brain Res. 2011 Aug 10;221(2):564-73. doi: 10.1016/j.bbr.2009.12.048. Epub 2010 Jan 7.

  PMID: 20060022 BACKGROUND

• Karachi C, Grabli D, Bernard FA, Tande D, Wattiez N, Belaid H, Bardinet E, Prigent A, Nothacker HP, Hunot S, Hartmann A, Lehericy S, Hirsch EC, Francois C. Cholinergic mesencephalic neurons are involved in gait and postural disorders in Parkinson disease. J Clin Invest. 2010 Aug;120(8):2745-54. doi: 10.1172/JCI42642. Epub 2010 Jul 12.

  PMID: 20628197 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Varenicline; Sugars

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Carbohydrates

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.

Results Point of Contact

• Title: Deborah A Hall MD PhD
• Organization: Rush University Medical Center

Deborah_A_Hall@rush.edu

312-563-2900

Study Officials

• Deborah A Hall, MD, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: April 25, 2011
• Study Start: December 28, 2010
• Primary Completion: November 2, 2018
• Study Completion: November 2, 2018
• Last Updated: December 30, 2022
• Results First Posted: December 30, 2022

Record last verified: 2022-12

Locations

US (1)