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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01341080
Recruitment Status : Recruiting
First Posted : April 25, 2011
Last Update Posted : August 30, 2017
Information provided by (Responsible Party):
Deborah Hall, MD, Rush University Medical Center

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Varenicline Drug: Sugar pill Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Varenicline for the Treatment of Postural and Gait Dysfunction in Parkinson Disease
Study Start Date : November 2010
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Berg Balance Scale [ Time Frame: 9 weeks ]

Secondary Outcome Measures :
  1. MDS-UPDRS [ Time Frame: 9 weeks ]
    The Movement Disorder Society version of the Unified Parkison Disease Rating Scale

  2. Timed Up and Go test [ Time Frame: 9 weeks ]
  3. Activities Specific Balance Scale [ Time Frame: 9 weeks ]
  4. Beck Depression Inventory - II [ Time Frame: 9 weeks ]
  5. Beck Suicide Scale [ Time Frame: 9 weeks ]
  6. Frontal Assessment Battery [ Time Frame: 9 weeks ]
  7. Mini Mental Status Exam [ Time Frame: 9 weeks ]
  8. Freezing of Gait Questionnaire [ Time Frame: 9 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01341080

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Contact: Deborah Hall, MD PhD 312-563-2900
Contact: Brian J Kelly 312-563-2900

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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
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Principal Investigator: Deborah A Hall, MD, PhD Rush University Medical Center

Additional Information:
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Responsible Party: Deborah Hall, MD, MD, Rush University Medical Center Identifier: NCT01341080     History of Changes
Other Study ID Numbers: WS813511
First Posted: April 25, 2011    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

Keywords provided by Deborah Hall, MD, Rush University Medical Center:
Postural impairment
Parkinson Disease

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