Status:
COMPLETED
Modulation of GABA-A Receptors in Parkinson Disease-Transdermal Flumazenil Arm
Lead Sponsor:
Nicolaas Bohnen, MD, PhD
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Parkinson Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
Brief Summary
The arm of this study evaluates possible GABA-A receptor target engagement effects of the FDA-approved medication, transdermal flumazenil (added 4/2020, replaced clarithromycin), in the setting of Par...
Detailed Description
This study focuses on neurochemical changes in the brain that occur in Parkinson's disease. In particular we will be looking a neurotransmitter called GABA. In some Parkinson's disease patients we see...
Eligibility Criteria
Inclusion
- Parkinson's disease (PD): PD diagnosis will follow the UK Parkinson's Disease Society Brain Bank Research Center (UKPDSBRC) clinical diagnostic criteria for PD.
- Hoehn and Yahr stages 2-4
- Absence of dementia confirmed by cognitive testing.
- Abnormal 11C-Dihydrotetrabenazine (\[11c\]-DTBZ) PET study to demonstrate nigrostriatal dopaminergic denervation
Exclusion
- PD with Dementia (PDD) or dementia with Lewy bodies (DLB).
- Other disorders which may resemble PD, such as vascu¬lar dementia, normal pressure hydrocephalus, multiple system atrophy, corticobasal ganglionic dege¬neration, or toxic causes of parkinsonism. Prototypical cases have distincti¬ve clinical profiles, like early and severe dysautonomia or appendicular apraxia, which may differentiate them from idiopathic PD. The use of the UKPDSBRC clinical diagnostic criteria for PD will mitigate the inclusion of subjects with atypical parkinsonism.
- Subjects currently on benzodiazepine, GABAB-ergic medications (baclofen, tizanidine), modafinil, neuroleptic, anticholinergic (trihexyphenidyl, benztropine), or cholinesterase inhibitor drugs.
- Evidence of a mass lesion on structural brain imaging (MRI).
- Participants in whom MRI is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, chest, or cochlear implant.
- Severe claustrophobia precluding MR or PET imaging.
- Subjects limited by participation in research procedures involving ionizing radiation.
- Pregnancy (urine or serum pregnancy test within 48 hours of each PET session) or breastfeeding.
- History of seizures
- Significant anxiety or history of panic disorder.
- History of recent suicide attempt or overdose of tricyclic antidepressants or other medications.
- History of transient ischemic attack (TIA) or stroke within the last year.
- History of systemic lupus erythematosis.
- Abnormal liver enzymes (AST or ALT) \> 3 times upper limit of normal.
- History of atrial fibrillation.
- History of retinal branch artery occlusion.
- Active dermatitis inner forearms.
- Any other medical history determined by investigators to preclude safe participation.
- Additional Exclusion Criteria for Flumazenil sub-studies:
- Allergy to flumazenil
- Significant liver disease
- History of alcohol or other substance abuse within past two years.
- Subjects currently taking benzodiazepines
Key Trial Info
Start Date :
January 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03440112
Start Date
January 29 2018
End Date
December 8 2021
Last Update
January 10 2023
Active Locations (1)
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1
University of Michigan Health System Functional Neuroimaging, Cognitive and Mobility Laboratory
Ann Arbor, Michigan, United States, 48106