Trial · NCT03440112
Modulation of GABA-A Receptors in Parkinson Disease-Transdermal Flumazenil Arm
NCT03440112, Phase 1, Phase 2, Completed, Nicolaas Bohnen, MD, PhD; results first posted 2023-01-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Modulation of GABA-A Receptors in Parkinson Disease-Transdermal Flumazenil Arm. Trials, record NCT03440112. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03440112
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Modulation of GABA-A Receptors in Parkinson Disease-Transdermal Flumazenil Arm
- NCT number
- NCT03440112
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- Nicolaas Bohnen, MD, PhD
- Conditions
- Parkinson Disease
- Interventions
- Clarithromycin (Not used as of 4/2020), Placebo (Not used as of 4/2020), Transdermal flumazenil (Added 4/2020), Placebo (Added 4/2020)
- First posted
- 2018-02-20
- Last updated
- 2023-01-10
- Results first posted
- 2023-01-10
- Limitations and caveats
Our participants were predominantly male, which is often the case with Parkinson's disease (PD) patient population since PD is known to affect males at a greater rate. This means that our findings may not generalize as well to population of female PD patients.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Quantitative Biomechanics 1 (Clinical Motor Ratings MDS-UPDRS) | 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. |
| Secondary | Change in Quantitative Biomechanics 2 (MiniBESTest Dynamic Balance Scale Sensory Subscore) | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Quantitative Biomechanics 1 (Clinical Motor Ratings MDS-UPDRS) | Day 1 (before treatment administration), day 7 (after 7 days of treatment), and day 14 (7 days of treatment discontinuation). | Parkinson's disease participants older than 50. Some, but not all, participants in the Clarithromycin arm were randomized, and only few completed study procedures because of premature termination of the trial due to an FDA safety risk warning of Clarithromycin, precluding any meaningful analysis. Consequently, this study arm was replaced by the transdermal Flumazenil arm. | units on a scale | MEDIAN |
| SECONDARY | Change in Quantitative Biomechanics 2 (MiniBESTest Dynamic Balance Scale Sensory Subscore) | Day 1 (before treatment administration), day 7 (after 7 days of treatment), and day 14 (7 days of treatment discontinuation). | Parkinson's disease participants older than 50. Some, but not all, participants in the Clarithromycin arm were randomized, and only few completed study procedures (baseline visit only) because of premature termination of the trial due to an FDA safety risk warning of Clarithromycin, precluding any meaningful analysis. Consequently, this study arm was replaced by the transdermal Flumazenil arm. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Quantitative Biomechanics 1 (Clinical Motor Ratings MDS-UPDRS) | Transdermal Flumazenil (Active) | Day 1 | 38 | Inter-Quartile Range 27.5 to 44.5 | units on a scale |
| Change in Quantitative Biomechanics 1 (Clinical Motor Ratings MDS-UPDRS) | Placebo Cream | Day 1 | 34 | Inter-Quartile Range 30 to 47 | units on a scale |
| Change in Quantitative Biomechanics 1 (Clinical Motor Ratings MDS-UPDRS) | Clarithromycin (Active or Placebo) | Day 1 | 28 | Inter-Quartile Range 25.50 to 33.00 | units on a scale |
| Change in Quantitative Biomechanics 1 (Clinical Motor Ratings MDS-UPDRS) | Transdermal Flumazenil (Active) | Day 7 | 36.75 | Inter-Quartile Range 29.75 to 52 | units on a scale |
| Change in Quantitative Biomechanics 1 (Clinical Motor Ratings MDS-UPDRS) | Placebo Cream | Day 7 | 31.50 | Inter-Quartile Range 25.375 to 43.375 | units on a scale |
| Change in Quantitative Biomechanics 1 (Clinical Motor Ratings MDS-UPDRS) | Clarithromycin (Active or Placebo) | Day 7 | 23.50 | Inter-Quartile Range 21.25 to 26.75 | units on a scale |
| Change in Quantitative Biomechanics 1 (Clinical Motor Ratings MDS-UPDRS) | Transdermal Flumazenil (Active) | Day 14 | 32.75 | Inter-Quartile Range 26.375 to 47.375 | units on a scale |
| Change in Quantitative Biomechanics 1 (Clinical Motor Ratings MDS-UPDRS) | Placebo Cream | Day 14 | 34 | Inter-Quartile Range 29.5 to 40 | units on a scale |
| Change in Quantitative Biomechanics 1 (Clinical Motor Ratings MDS-UPDRS) | Clarithromycin (Active or Placebo) | Day 14 | 22 | Inter-Quartile Range 19.5 to 23.0 | units on a scale |
| Change in Quantitative Biomechanics 2 (MiniBESTest Dynamic Balance Scale Sensory Subscore) | Transdermal Flumazenil (Active) | Day 1 | 5.54 | Standard Deviation 0.69 | units on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Transdermal Flumazenil (Active) | 11 | |
| Overall Study | STARTED | Placebo Cream | 11 | |
| Overall Study | STARTED | Oral Clarithromycin (Dropped in 04/2020) | 3 | |
| Overall Study | COMPLETED | Transdermal Flumazenil (Active) | 11 | |
| Overall Study | COMPLETED | Placebo Cream | 11 | |
| Overall Study | COMPLETED | Oral Clarithromycin (Dropped in 04/2020) | 3 | |
| Overall Study | NOT COMPLETED | Transdermal Flumazenil (Active) | 0 | |
| Overall Study | NOT COMPLETED | Placebo Cream | 0 | |
| Overall Study | NOT COMPLETED | Oral Clarithromycin (Dropped in 04/2020) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Transdermal Flumazenil (Active) | 0 | 11 |
| Total, all-cause mortality | Placebo Cream | 0 | 11 |
| Total, all-cause mortality | Oral Clarithromycin (Dropped in 04/2020) | 0 | 3 |
| Total, other adverse events | Transdermal Flumazenil (Active) | 0 | 11 |
| Total, other adverse events | Placebo Cream | 0 | 11 |
| Total, other adverse events | Oral Clarithromycin (Dropped in 04/2020) | 0 | 3 |
| Total, serious adverse events | Transdermal Flumazenil (Active) | 0 | 11 |
| Total, serious adverse events | Placebo Cream | 0 | 11 |
| Total, serious adverse events | Oral Clarithromycin (Dropped in 04/2020) | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01NS099535 | Modulation of GABA-A Receptors and Axial Motor Impairments in Parkinson Disease | BOHNEN, NICOLAAS IDA | UNIVERSITY OF MICHIGAN AT ANN ARBOR | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2017 to 2020 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03440112
GET https://conductscience.org/api/trials/v1/NCT03440112/registered