Modulation of GABA-A Receptors in Parkinson Disease-Transdermal Flumazenil Arm
NCT ID: NCT03440112
Last Updated: 2023-01-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
34 participants
INTERVENTIONAL
2018-01-29
2021-12-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Clarithromycin (Not used anymore as of 4/2020; study aborted)
Clarithromycin 250mg (1 capsule) will be taken orally twice a day for 3 days and if tolerated will be increased to 500mg (2 capsules) orally twice a day for 4-6 days.
Clarithromycin (Not used as of 4/2020)
Clarithromycin (generic) capsule 250mg each
Placebo (Not used anymore as of 4/2020; study aborted)
Placebo will be taken exactly as the clarithromycin arm: 1 capsule orally twice a day for 3 days and if tolerated will be increased to 2 capsules orally twice a day for 4-6 days.
Placebo (Not used as of 4/2020)
Lactose in a gel capsule
Transdermal flumazenil (added 4/2020 as safer alternative for clarithromycin)
Added in April 2020. Subjects will take 18mg transdermal application every 3-4 hrs dispensed as 3 dispenser bottle clicks of 0.25 ml each, while awake for 3 days then if no side-effects subjects will increase to 36mg transdermal application every 3-4 hrs dispensed as 6 dispenser bottle clicks of 0.25 ml each, while awake.
Transdermal flumazenil (Added 4/2020)
Transdermal flumazenil 24mg/mL
Placebo cream (added 4/2020)
Added in April 2020. Placebo will be taken exactly as the transdermal flumazenil arm: Subjects will take 18mg transdermal application every 3-4 hrs dispensed as 3 dispenser bottle clicks of 0.25 ml each, while awake for 3 days then if no side-effects subjects will increase to 36mg transdermal application every 3-4 hrs dispensed as 6 dispenser bottle clicks of 0.25 ml each, while awake.
Placebo (Added 4/2020)
Transdermal placebo
Interventions
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Placebo (Not used as of 4/2020)
Lactose in a gel capsule
Transdermal flumazenil (Added 4/2020)
Transdermal flumazenil 24mg/mL
Placebo (Added 4/2020)
Transdermal placebo
Clarithromycin (Not used as of 4/2020)
Clarithromycin (generic) capsule 250mg each
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Hoehn and Yahr stages 2-4
3. Absence of dementia confirmed by cognitive testing.
4. Abnormal 11C-Dihydrotetrabenazine (\[11c\]-DTBZ) PET study to demonstrate nigrostriatal dopaminergic denervation
Exclusion Criteria
2. 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.
3. Subjects currently on benzodiazepine, GABAB-ergic medications (baclofen, tizanidine), modafinil, neuroleptic, anticholinergic (trihexyphenidyl, benztropine), or cholinesterase inhibitor drugs.
4. Evidence of a mass lesion on structural brain imaging (MRI).
5. 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.
6. Severe claustrophobia precluding MR or PET imaging.
7. Subjects limited by participation in research procedures involving ionizing radiation.
8. Pregnancy (urine or serum pregnancy test within 48 hours of each PET session) or breastfeeding.
9. History of seizures
10. Significant anxiety or history of panic disorder.
11. History of recent suicide attempt or overdose of tricyclic antidepressants or other medications.
12. History of transient ischemic attack (TIA) or stroke within the last year.
13. History of systemic lupus erythematosis.
14. Abnormal liver enzymes (AST or ALT) \> 3 times upper limit of normal.
15. History of atrial fibrillation.
16. History of retinal branch artery occlusion.
17. Active dermatitis inner forearms.
18. Any other medical history determined by investigators to preclude safe participation.
1. Allergy to flumazenil
2. Significant liver disease
3. History of alcohol or other substance abuse within past two years.
4. Subjects currently taking benzodiazepines
50 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Nicolaas Bohnen, MD, PhD
OTHER
Responsible Party
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Nicolaas Bohnen, MD, PhD
Professor of Radiology and Neurology
Principal Investigators
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Nicolaas I Bohnen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan Health System Functional Neuroimaging, Cognitive and Mobility Laboratory
Ann Arbor, Michigan, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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HUM00360361-A
Identifier Type: -
Identifier Source: org_study_id
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