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Varenicline for Gait and Balance Impairment in Parkinson Disease (Chantix-PD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Rush University Medical Center
Sponsor:
Information provided by (Responsible Party):
Deborah Hall, MD, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01341080
First received: April 21, 2011
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Parkinson Disease
Drug: Varenicline
Drug: Sugar pill
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Varenicline for the Treatment of Postural and Gait Dysfunction in Parkinson Disease

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Berg Balance Scale [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MDS-UPDRS [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    The Movement Disorder Society version of the Unified Parkison Disease Rating Scale

  • Timed Up and Go test [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Activities Specific Balance Scale [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Beck Depression Inventory - II [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
  • Beck Suicide Scale [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
  • Frontal Assessment Battery [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Mini Mental Status Exam [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Freezing of Gait Questionnaire [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Varenicline Drug: Varenicline
Varenicline 1mg twice daily for eight weeks after a one week dose escalation period.
Other Name: Chantix
Placebo Comparator: Sugar pill Drug: Sugar pill
1mg twice daily for eight weeks after a one week dose escalation phase.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects will be diagnosed with Parkinson Disease (PD) by the 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).

Exclusion Criteria:

  • 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.
  • A cardiovascular procedure in the last 5 years (eg, percutaneous transluminal coronary angioplasty) or have cardiovascular instability (including myocardial infarction or unstable angina). Other cardiovascular exclusions include uncontrolled hypertension, significant neurological sequelae of cerebrovascular disease, peripheral vascular disease with prior amputation, or severe congestive heart failure (New York Heart Association class III or IV).
  • Concurrent treatment with any 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.
  • Serious illness (requiring systemic treatment/or hospitalization) until the subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 60 days prior to study entry.
  • Inability or unwillingness of the subject or legal guardian/representative to give written informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341080

Contacts
Contact: Deborah Hall, MD PhD 312-563-2900 deborah_a_hall@rush.edu
Contact: Luci Blasucci, RN 312-563-2900 lucia_m_blasucci@rush.edu

Locations
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Deborah A Hall, MD, PhD         
Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: Deborah A Hall, MD, PhD Rush University Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Deborah Hall, MD, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01341080     History of Changes
Other Study ID Numbers: WS813511
Study First Received: April 21, 2011
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Rush University Medical Center:
Balance
Postural impairment
Falls
Parkinson Disease

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Varenicline
Cholinergic Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014