Trial · NCT03462641
Modulation of GABA-A Receptors in Parkinson Disease-Flumazenil Arm
NCT03462641, Phase 1, Phase 2, Completed, University of Michigan; results first posted 2022-06-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Modulation of GABA-A Receptors in Parkinson Disease-Flumazenil Arm. Trials, record NCT03462641. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03462641
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-Flumazenil Arm
- NCT number
- NCT03462641
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- Parkinson Disease
- Interventions
- Flumazenil, Placebo
- First posted
- 2018-03-12
- Last updated
- 2022-09-27
- Results first posted
- 2022-06-29
- 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 | Postural Instability and Gait Disorder (PIGD) Score | up to 3 hours (including pre and post infusion motor evaluation) | Postural Instability and Gait Disorder (PIGD) score is a subscale score of MDS-UPDRS scale. It is computed as a sum of following MDS-UPDRS items: 3.10 Gait 3.11 Freezing of gait 3.12 Postural stability 3.13 Posture Minimal possible score is 0, maximal possible score is 16. Higher scores indicate greater severity of PIGD symptoms (worse outcome). |
| Primary | PIGD Score Change | up to 3 hours (including pre and post infusion motor evaluation) | Difference in PIGD score from pre-infusion to post-infusion. Only observations where PIGD score change is less than 0 (decrease) are retained, as the hypothesis we are interested is whether the effect magnitude of flumazenil on PIGD score depends on baseline GABA-A receptor binding as assesed by FMZ PET. |
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 | Postural Instability and Gait Disorder (PIGD) Score | up to 3 hours (including pre and post infusion motor evaluation) | MDS-UPDRS PIGD scores for the same set of 28 participants, recorded before and after treatment (placebo or flumazenil) administration. | score on a scale | MEAN |
| PRIMARY | PIGD Score Change | up to 3 hours (including pre and post infusion motor evaluation) | A subset of participants assigned to each sequence which showed a decrease in PIGD score from pre-infusion to post-infusion for placebo or flumazenil treatment. A total of 12 participants are included in this analysis, with some of them showing response in both placebo and flumazenil condition and others in one of the two. | Change in PIGD Score | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Postural Instability and Gait Disorder (PIGD) Score | Placebo | Before Infusion | 4.625 | Standard Deviation 2.36 | score on a scale |
| Postural Instability and Gait Disorder (PIGD) Score | Flumazenil | Before Infusion | 4.625 | Standard Deviation 2.34 | score on a scale |
| Postural Instability and Gait Disorder (PIGD) Score | Placebo | After Infusion | 4.23 | Standard Deviation 2.15 | score on a scale |
| Postural Instability and Gait Disorder (PIGD) Score | Flumazenil | After Infusion | 4.09 | Standard Deviation 2.00 | score on a scale |
| PIGD Score Change | Placebo Responders | -1.375 | Standard Deviation 0.5175492 | Change in PIGD Score | |
| PIGD Score Change | Flumazenil Responders | -2.500 | Standard Deviation 1.5165751 | Change in PIGD Score |
Source ClinicalTrials.gov
Participant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Visit 1 | STARTED | Sequence A - (Flumazenil at Visit 1) | 19 | |
| Visit 1 | STARTED | Sequence B - (Placebo at Visit 1) | 11 | |
| Visit 1 | Actually Received Drug or Placebo | Sequence A - (Flumazenil at Visit 1) | 18 | |
| Visit 1 | Actually Received Drug or Placebo | Sequence B - (Placebo at Visit 1) | 11 | |
| Visit 1 | COMPLETED | Sequence A - (Flumazenil at Visit 1) | 18 | |
| Visit 1 | COMPLETED | Sequence B - (Placebo at Visit 1) | 11 | |
| Visit 1 | NOT COMPLETED | Sequence A - (Flumazenil at Visit 1) | 1 | |
| Visit 1 | NOT COMPLETED | Sequence B - (Placebo at Visit 1) | 0 | |
| Visit 2 | STARTED | Sequence A - (Flumazenil at Visit 1) | 18 | |
| Visit 2 | STARTED | Sequence B - (Placebo at Visit 1) | 11 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Treatment | 0 | 29 |
| Total, all-cause mortality | Flumazenil Treatment | 0 | 28 |
| Total, other adverse events | Placebo Treatment | 0 | 29 |
| Total, other adverse events | Flumazenil Treatment | 0 | 28 |
| Total, serious adverse events | Placebo Treatment | 0 | 29 |
| Total, serious adverse events | Flumazenil Treatment | 0 | 28 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Flumazenil Treatment vs Placebo Treatment: deaths from any cause | Trial comparisons |
| Flumazenil Treatment vs Placebo Treatment: serious adverse events | Trial comparisons |
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/NCT03462641
GET https://conductscience.org/api/trials/v1/NCT03462641/registered