Trial · NCT02120365
Rapid Determination Of The Clinical Utility Of Perampanel For The Treatment Of Alcohol Dependence
NCT02120365, Phase 1, Phase 2, Completed, Virginia Commonwealth University; results first posted 2023-08-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rapid Determination Of The Clinical Utility Of Perampanel For The Treatment Of Alcohol Dependence. Trials, record NCT02120365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02120365
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rapid Determination Of The Clinical Utility Of Perampanel For The Treatment Of Alcohol Dependence
- NCT number
- NCT02120365
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Virginia Commonwealth University
- Conditions
- Alcoholism
- Interventions
- Perampanel, Placebo
- First posted
- 2014-04-22
- Last updated
- 2023-08-18
- Results first posted
- 2023-08-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Biphasic Alcohol Effects Scale (BAES): Stimulant Subscale | 98 minutes | A 14-item scale with 7 items designed to assess stimulant effects from alcohol intoxication and 7 items developed to measure the sedative effects of alcohol. This scale was selected as a primary outcome measure because it is sensitive to the effect of alcohol. This outcome item reports the Stimulant Subscale results analyzed with mixed models. Each item can be scored a minimum of zero (0) or up to 10 with the 10 representing feeling more or the most intoxicated in that item's description (e.g., "excited"). The minimum score is 0 and the maximum score is 70. For the time frame, the values at different time points were combined (averaged) into a single value that represents the effect during the time interval of interest (12 to 110 minutes). |
| Primary | Biphasic Alcohol Effects Scale (BAES)- Sedative Subscale | 98 minutes | A 14-item scale with 7 items designed to assess stimulant effects from alcohol intoxication and 7 items developed to measure the sedative effects of alcohol. This scale was selected as a primary outcome measure because it is sensitive to the effect of alcohol. This entry item show the results for the sedative subscale evaluated in mixed models. Each item can be scored a minimum of zero (0) or up to 10 with the 10 representing feeling more or the most intoxicated in that item's description (e.g., "sedated"). The minimum score is 0 and the maximum score is 70. For the time frame, the values at different time points were combined (averaged) into a single value that represents the effect during the time interval of interest (12 to 110 minutes). |
| Primary | Drug Effects Questionaire (DEQ) | 98 min | consists of four items that measure current alcohol effects: 'feel alcohol', 'feel high', 'like alcohol', and 'want more alcohol'. For the time frame, the values at different time points were combined (averaged) into a single value that represents the effect during the time interval of interest (12 to 110 minutes). There are five items on the scale with scores of 0 to 100, and the total score is used by averaging all five items, thus, the minimum total score on the scale is 0 and the maximum is 100. The lowest score 0 represents "not at all" or not experiencing any drug effects from alcohol, and 100 represents "extremely" experiencing alcohol effects. |
| Secondary | Alcohol Urge Questionnaire (AUQ) | 98 min | A valid eight-item Likert-type scale designed to assess acute alcohol craving. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores. Higher scores reflect greater craving. The minimum score is 7, and the maximum is 49. For the time frame, the values at different time points were combined (averaged) into a single value that represents the effect during the time interval of interest (12 to 110 minutes). |
| Secondary | Side Effect Questionnaire (SEQ) | 98 minutes | This consists of a list of side effects associated with perampanel (e.g., fatigue, dizziness), rated from 0="none" to 4="severe". The mean for each subject across all items is included in each group/arm mean. The lowest score on the scale would be 0 and the maximum 4, as the mean across items is taken and not a sum. For the time frame, the values at different time points were combined (averaged) into a single value that represents the effect during the time interval of interest (12 to 110 minutes). |
| Secondary | Profile of Mood States (POMS) 2 Short Version Total Score | 98 minutes | The Profile of Mood States (POMS) 2 short version contains a subset of 35 items from the full-length versions. This subset comprises those five items on full version POMS scale that exhibited good item-total correlations and best predicted their respective scale scores, this is a TOTAL score Representing total mood disturbance. For the time frame, the values at different time points were combined (averaged) into a single value that represents the effect during the time interval of interest (12 to 110 minutes). The minimum is 0 and the maximum is 100 with higher numbers indicating greater mood disturbance. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Biphasic Alcohol Effects Scale (BAES): Stimulant Subscale | 98 minutes | Non-treatment Seeking Heavy Drinkers of whom all participated in three separate lab days, each following a different dose of perampanel or placebo. | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Biphasic Alcohol Effects Scale (BAES)- Sedative Subscale | 98 minutes | score on a scale | LEAST_SQUARES_MEAN | |
| PRIMARY | Drug Effects Questionaire (DEQ) | 98 min | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Alcohol Urge Questionnaire (AUQ) | 98 min | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Side Effect Questionnaire (SEQ) | 98 minutes | Non-Treatment Seeking Heavy Drinkers | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Profile of Mood States (POMS) 2 Short Version Total Score | 98 minutes | Nontreatment-seeking Heavy Drinkers (NTSHDs) | score on a scale | LEAST_SQUARES_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 |
|---|---|---|---|---|---|
| Biphasic Alcohol Effects Scale (BAES): Stimulant Subscale | Placebo Medication Dose | 13.756 | Standard Error 2.747 | score on a scale | |
| Biphasic Alcohol Effects Scale (BAES): Stimulant Subscale | Perampanel 6mg Dose | 14.053 | Standard Error 2.658 | score on a scale | |
| Biphasic Alcohol Effects Scale (BAES): Stimulant Subscale | Perampanel 10mg Dose | 13.026 | Standard Error 2.816 | score on a scale | |
| Biphasic Alcohol Effects Scale (BAES)- Sedative Subscale | Placebo | 4.624 | Standard Deviation 1.784 | score on a scale | |
| Biphasic Alcohol Effects Scale (BAES)- Sedative Subscale | Perampanel 6mg | 7.159 | Standard Deviation 1.649 | score on a scale | |
| Biphasic Alcohol Effects Scale (BAES)- Sedative Subscale | Perampanel 10 mg | 10.263 | Standard Deviation 1.797 | score on a scale | |
| Drug Effects Questionaire (DEQ) | Placebo Medication Dose | 42.538 | Standard Error 3.379 | score on a scale | |
| Drug Effects Questionaire (DEQ) | Perampanel 6mg Dose | 40.619 | Standard Error 3.269 | score on a scale | |
| Drug Effects Questionaire (DEQ) | Perampanel 10mg Dose | 43.267 | Standard Error 3.442 | score on a scale | |
| Alcohol Urge Questionnaire (AUQ) | Placebo Medication Dose | 16.481 | Standard Error 1.266 | score on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo, Then Perampanel 6mg, Then Perampanel 10mg | 4 | |
| Overall Study | STARTED | Placebo, Then Perampanel 10mg, Then Perampanel 6mg | 4 | |
| Overall Study | STARTED | Perampanel 6mg, Then Placebo, Then Perampanel 10mg | 5 | |
| Overall Study | STARTED | Perampanel 6mg, Then Perampanel 10mg, Then Placebo | 4 | |
| Overall Study | STARTED | Perampanel 10mg, Then Perampanel 6mg, Then Placebo | 3 | |
| Overall Study | STARTED | Perampanel 10mg, Then Placebo, Then Perampanel 6mg | 2 | |
| Overall Study | COMPLETED | Placebo, Then Perampanel 6mg, Then Perampanel 10mg | 4 | |
| Overall Study | COMPLETED | Placebo, Then Perampanel 10mg, Then Perampanel 6mg | 4 | |
| Overall Study | COMPLETED | Perampanel 6mg, Then Placebo, Then Perampanel 10mg | 3 | |
| Overall Study | COMPLETED | Perampanel 6mg, Then Perampanel 10mg, Then Placebo | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | nausea/vomiting | Gastrointestinal disorders | Placebo | 1 | 22 | 1 |
| other | nausea/vomiting | Gastrointestinal disorders | Perampanel 6mg | 0 | 22 | 0 |
| other | nausea/vomiting | Gastrointestinal disorders | Perampanel 10 mg | 2 | 22 | 2 |
| other | IV site bruising/thrombosis | Skin and subcutaneous tissue disorders | Placebo | 1 | 22 | 1 |
| other | IV site bruising/thrombosis | Skin and subcutaneous tissue disorders | Perampanel 6mg | 1 | 22 | 1 |
| other | IV site bruising/thrombosis | Skin and subcutaneous tissue disorders | Perampanel 10 mg | 0 | 22 | 0 |
| other | Viral cold symptoms | Infections and infestations | Placebo | 1 | 22 | 1 |
| other | Viral cold symptoms | Infections and infestations | Perampanel 6mg | 0 | 22 | 0 |
| other | Viral cold symptoms | Infections and infestations | Perampanel 10 mg | 0 | 22 | 0 |
| other | dysuria | Renal and urinary disorders | Placebo | 1 | 22 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 22 |
| Total, all-cause mortality | Perampanel 6mg | 0 | 22 |
| Total, all-cause mortality | Perampanel 10 mg | 0 | 22 |
| Total, other adverse events | Placebo | 4 | 22 |
| Total, other adverse events | Perampanel 6mg | 1 | 22 |
| Total, other adverse events | Perampanel 10 mg | 4 | 22 |
| Total, serious adverse events | Placebo | 0 | 22 |
| Total, serious adverse events | Perampanel 6mg | 0 | 22 |
| Total, serious adverse events | Perampanel 10 mg | 0 | 22 |
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 |
|---|---|---|---|---|---|
| R21AA026681 | Perampanel Treatment of Alcohol Use Disorder | ARIAS, ALBERT JOSEPH | VIRGINIA COMMONWEALTH UNIVERSITY | NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM | 2018 to 2019 |
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/NCT02120365
GET https://conductscience.org/api/trials/v1/NCT02120365/registered