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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 July 2021 |
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Main ID: |
NCT03462641 |
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Date of registration:
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06/03/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Modulation of GABA-A Receptors in Parkinson Disease-Flumazenil Arm
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Scientific title:
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Modulation of GABA-A Receptors and Axial Motor Impairments in Parkinson Disease-Flumazenil Arm |
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Date of first enrolment:
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March 9, 2018 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03462641 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Nicolaas I Bohnen, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Michigan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Parkinson's disease (PD): PD diagnosis will follow the UK Parkinson's Disease Society
Brain Bank Research Center (UKPDSBRC) clinical diagnostic criteria for PD.
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:
1. PD with Dementia (PDD) or dementia with Lewy bodies (DLB).
2. Other disorders which may resemble PD, such as vascular dementia, normal pressure
hydrocephalus, multiple system atrophy, corticobasal ganglionic degeneration, or toxic
causes of parkinsonism. Prototypical cases have distinctive 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 on benzodiazepine, GABA-ergic medications (baclofen, tizanidine),
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. Any other medical history determined by investigators to preclude safe participation.
13. Allergy to flumazenil
14. Significant liver disease
15. History of alcohol or other substance abuse within past two years.
16. History of regular benzodiazepine use within past year
Age minimum:
50 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Drug: Flumazenil
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Drug: Placebo
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Primary Outcome(s)
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Change in quantitative biomechanics
[Time Frame: up to 3 hours (including pre- and post-infusion motor testing)]
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Secondary ID(s)
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R01NS099535
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HUM00130361
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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