Trial · NCT00368108
Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
NCT00368108, Phase 3, Completed, Eisai Inc.; results first posted 2013-02-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations. Trials, record NCT00368108. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00368108
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
- NCT number
- NCT00368108
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 752 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Parkinson's Disease
- Interventions
- 2 mg perampanel, 4 mg perampanel, placebo comparator
- First posted
- 2006-08-24
- Last updated
- 2013-05-20
- Results first posted
- 2013-02-05
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data) | Baseline and Week 20 | Patients described themselves in home diaries as "OFF", "ON" without dyskinesias, "ON" with non troublesome dyskinesias, "ON" with troublesome dyskinesias, or Asleep, every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 10, 18, and 20. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. |
| Secondary | Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data) | Baseline and Week 20 | Patients described themselves in home diaries every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 12, 16, and 20. Unified Parkinson's Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD. Part II assesses Activities of Daily Living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 52. ON state is when medication is providing benefits to mobility, slowness, and stiffness. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. |
| Secondary | Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data) | Baseline and Week 20 | Patients described themselves in home diaries every 30 minutes during waking hours for 3 days prior to Baseline, Weeks 8, 12, 16, and 20. UPDRS is a standardized assessment of the symptoms and signs of PD. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. ON state is when medication is providing benefits to stiffness, slowness, and tremor. |
| Secondary | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 20 (Including LOCF Data) | Baseline and Week 20 | Patients described themselves in home diaries every 30 minutes during waking hours for 3 days prior to Baseline, Weeks 8, 12, 16, and 20. ON state is when medication is providing benefits to stiffness, slowness, and tremor. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data) | Baseline and Week 20 | The Intent-to-treat (ITT) Population for diary data consisted of all subjects who were randomized to either perampanel or placebo, had taken at least 1 dose, had a valid, nonmissing Baseline diary measurement and at least 1 valid, non-missing, postbaseline diary measurement at Last Observation Carried Forward (LOCF). | Hours | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data) | Baseline and Week 20 | ITT Population | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data) | Baseline and Week 20 | ITT Population | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 20 (Including LOCF Data) | Baseline and Week 20 | ITT Population | Hours | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data) | Placebo | -0.96 | 95% Confidence Interval -1.42 to -0.51 | Hours | |
| Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data) | Perampanel 2mg | -0.93 | 95% Confidence Interval -1.38 to -0.49 | Hours | |
| Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data) | Perampanel 4mg | -0.76 | 95% Confidence Interval -1.20 to -0.31 | Hours | |
| Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data) | Placebo | -0.85 | 95% Confidence Interval -1.70 to -0.00 | Scores on a scale | |
| Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data) | Perampanel 2mg | -0.81 | 95% Confidence Interval -1.66 to 0.04 | Scores on a scale | |
| Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data) | Perampanel 4mg | -1.40 | 95% Confidence Interval -2.23 to -0.56 | Scores on a scale | |
| Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data) | Placebo | -2.15 | 95% Confidence Interval -3.59 to -0.71 | Scores on a Scale | |
| Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data) | Perampanel 2mg | -1.69 | 95% Confidence Interval -3.13 to -0.25 | Scores on a Scale | |
| Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data) | Perampanel 4mg | -3.29 | 95% Confidence Interval -4.71 to -1.87 | Scores on a Scale | |
| Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 20 (Including LOCF Data) | Placebo | 0.73 | 95% Confidence Interval 0.29 to 1.18 | Hours |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 251 | |
| Overall Study | STARTED | Perampanel 2mg | 251 | |
| Overall Study | STARTED | Perampanel 4mg | 250 | |
| Overall Study | COMPLETED | Placebo | 187 | |
| Overall Study | COMPLETED | Perampanel 2mg | 198 | |
| Overall Study | COMPLETED | Perampanel 4mg | 182 | |
| Overall Study | NOT COMPLETED | Placebo | 64 | |
| Overall Study | NOT COMPLETED | Perampanel 2mg | 53 | |
| Overall Study | NOT COMPLETED | Perampanel 4mg | 68 |
Source ClinicalTrials.gov
Adverse events189
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 | Gastrointestinal disorders | Placebo | 16 | 250 | |
| other | Nausea | Gastrointestinal disorders | Perampanel 2mg | 11 | 251 | |
| other | Nausea | Gastrointestinal disorders | Perampanel 4mg | 12 | 250 | |
| other | Urinary Tract Infection | Infections and infestations | Placebo | 10 | 250 | |
| other | Urinary Tract Infection | Infections and infestations | Perampanel 2mg | 11 | 251 | |
| other | Urinary Tract Infection | Infections and infestations | Perampanel 4mg | 13 | 250 | |
| other | Fall | Injury, poisoning and procedural complications | Placebo | 23 | 250 | |
| other | Fall | Injury, poisoning and procedural complications | Perampanel 2mg | 23 | 251 | |
| other | Fall | Injury, poisoning and procedural complications | Perampanel 4mg | 19 | 250 | |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Placebo | 7 | 250 |
1 to 10 of 189Source ClinicalTrials.gov
See all 189 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Perampanel 2mg | ||
| Total, all-cause mortality | Perampanel 4mg | ||
| Total, other adverse events | Placebo | 111 | 250 |
| Total, other adverse events | Perampanel 2mg | 110 | 251 |
| Total, other adverse events | Perampanel 4mg | 144 | 250 |
| Total, serious adverse events | Placebo | 22 | 250 |
| Total, serious adverse events | Perampanel 2mg | 12 | 251 |
| Total, serious adverse events | Perampanel 4mg | 18 | 250 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT00368108
GET https://conductscience.org/api/trials/v1/NCT00368108/events?page=2