Varenicline for Gait and Balance Impairment in Parkinson Disease (Chantix-PD)
The purpose of this study is to determine if varenicline is effective in improving gait and balance impairment in patients with Parkinson disease.
|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|
- Berg Balance Scale [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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.
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.
|Contact: Deborah Hall, MD PhDfirstname.lastname@example.org|
|Contact: Luci Blasucci, RNemail@example.com|
|United States, Illinois|
|Rush University Medical Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Principal Investigator: Deborah A Hall, MD, PhD|
|Principal Investigator:||Deborah A Hall, MD, PhD||Rush University Medical Center|