50 and older, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Quantitative Biomechanics 1 (Clinical Motor Ratings MDS-UPDRS)Primary· Day 1 (before treatment administration), day 7 (after 7 days of treatment), and day 14 (7 days of treatment discontinuation).
We will use the total Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III - motor scale rating scores to assess motor function. Scale from 0-132, higher scores indicate worse motor outcomes. Outcome measure was collected during dopaminergic medication ON state.
Day 1
Group
Value
95% CI
Transdermal Flumazenil (Active)
38
27.5 – 44.5
Placebo Cream
34
30 – 47
Clarithromycin (Active or Placebo)
28
25.50 – 33.00
Day 7
Group
Value
95% CI
Transdermal Flumazenil (Active)
36.75
29.75 – 52
Placebo Cream
31.50
25.375 – 43.375
Clarithromycin (Active or Placebo)
23.50
21.25 – 26.75
Day 14
Group
Value
95% CI
Transdermal Flumazenil (Active)
32.75
26.375 – 47.375
Placebo Cream
34
29.5 – 40
Clarithromycin (Active or Placebo)
22
19.5 – 23.0
Change in Quantitative Biomechanics 2 (MiniBESTest Dynamic Balance Scale Sensory Subscore)Secondary· Day 1 (before treatment administration), day 7 (after 7 days of treatment), and day 14 (7 days of treatment discontinuation).
MiniBEST sensory subscore measures an individual's ability to maintain balance under conditions of sensory constrain and unstable/inclined standing surface. It is is computed as a sum of MiniBEST items 7, 8, and 9.The score ranges from 0 to 6, with 0 indicating inability to balance under all of the condition, and 6 indicating no difficulty in maintaining balance under any of the conditions (lower score indicates worse balance). Outcome measure was collected during dopaminergic medication ON state.
Day 1
Group
Value
95% CI
Transdermal Flumazenil (Active)
5.54
± 0.69
Placebo Cream
6
± 0
Clarithromycin (Active or Placebo)
6
± 0
Day 7
Group
Value
95% CI
Transdermal Flumazenil (Active)
5.82
± 0.40
Placebo Cream
6
± 0
Clarithromycin (Active or Placebo)
5.67
± 0.58
Day 14
Group
Value
95% CI
Transdermal Flumazenil (Active)
6
± 0
Placebo Cream
5.82
± 0.60
Clarithromycin (Active or Placebo)
6
± 0
Sponsor's own description
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 Parkinson's disease. Half of the subjects will receive transdermal flumazenil for 7-10 days, and half will receive a placebo. \[11C\]Flumazenil GABA-A receptor PET imaging will be used to assess target engagement effects. Note \[11C\]Flumazenil GABA-A receptor PET was not performed as part of the transdermal flumazenil study because of a Covid pandemic research amendment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Nicolaas Bohnen, MD, PhD
Last refreshed: 10 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03440112.