Trial · NCT00360412
A Study of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
NCT00360412, Phase 3, Terminated, Eisai Inc.; results first posted 2013-02-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations. Trials, record NCT00360412. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00360412
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
- NCT number
- NCT00360412
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 997 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Parkinson's Disease
- Interventions
- E2007
- First posted
- 2006-08-04
- Last updated
- 2014-07-11
- Other registries' IDs
- eudract:2006-002339-26
- Results first posted
- 2013-02-05
- Limitations and caveats
Due to early termination, a limited number of subjects (only 2) completed this open-label extension study. The majority of subjects did not reach the scheduled Week 56 assessment. Many outcomes could only be analyzed to Week 68 as a result.
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) During Open-label Extension Study | Baseline, Week 0, Week 4, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68 | OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary. |
| Secondary | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | Baseline, Week 0, Week 4, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68 | ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary. |
| Secondary | Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study | Baseline, Week 0, Week, 8, Week 20, Week 32, Week 44, Week 56, Week 68 | Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. 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, for a range of total possible scores of 0-52. 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) During Open- Label Extension Study | Baseline, Week 0, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68 | Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. 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, for a range of total possible scores of 0-56. ON state is when medication is providing benefits with regard 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) During Open-label Extension Study | Baseline, Week 0, Week 4, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68 | Safety Population- all subjects entering the open-label extension study who took at least 1 dose of perampanel | Hours | MEAN |
| SECONDARY | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | Baseline, Week 0, Week 4, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68 | Safety Population | Hours | MEAN |
| SECONDARY | Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study | Baseline, Week 0, Week, 8, Week 20, Week 32, Week 44, Week 56, Week 68 | Safety Population | Scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study | Baseline, Week 0, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68 | Safety Population | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group60
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) During Open-label Extension Study | Perampanel (Placebo During Core Study) | Week 0 | -0.78 | Standard Deviation 2.158 | Hours |
| Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Week 0 | -0.85 | Standard Deviation 2.498 | Hours |
| Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Perampanel (Placebo During Core Study) | Week 4 | -1.37 | Standard Deviation 2.483 | Hours |
| Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Week 4 | -1.16 | Standard Deviation 2.632 | Hours |
| Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Perampanel (Placebo During Core Study) | Week 8 | -1.21 | Standard Deviation 2.400 | Hours |
| Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Week 8 | -1.19 | Standard Deviation 2.568 | Hours |
| Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Perampanel (Placebo During Core Study) | Week 20 | -1.11 | Standard Deviation 2.537 | Hours |
| Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Week 20 | -1.34 | Standard Deviation 2.694 | Hours |
| Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Perampanel (Placebo During Core Study) | Week 32 | -0.91 | Standard Deviation 2.663 | Hours |
| Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Week 32 | -1.38 | Standard Deviation 2.676 | Hours |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Perampanel (Placebo During Core Study) | 333 | |
| Overall Study | STARTED | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | 664 | |
| Overall Study | COMPLETED | Perampanel (Placebo During Core Study) | 0 | |
| Overall Study | COMPLETED | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | 2 | |
| Overall Study | NOT COMPLETED | Perampanel (Placebo During Core Study) | 333 | |
| Overall Study | NOT COMPLETED | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | 662 |
Source ClinicalTrials.gov
Adverse events214
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 | Fall | Injury, poisoning and procedural complications | Perampanel (Placebo During Core Study) | 24 | 333 | |
| other | Fall | Injury, poisoning and procedural complications | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | 32 | 664 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Perampanel (Placebo During Core Study) | 14 | 333 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | 35 | 664 | |
| other | Dyskinesia | Nervous system disorders | Perampanel (Placebo During Core Study) | 33 | 333 | |
| other | Dyskinesia | Nervous system disorders | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | 72 | 664 | |
| other | On and off phenomenon | Nervous system disorders | Perampanel (Placebo During Core Study) | 42 | 333 | |
| other | On and off phenomenon | Nervous system disorders | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | 73 | 664 | |
| other | Somnolence | Nervous system disorders | Perampanel (Placebo During Core Study) | 22 | 333 | |
| other | Somnolence | Nervous system disorders | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | 33 | 664 |
1 to 10 of 214Source ClinicalTrials.gov
See all 214 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Perampanel (Placebo During Core Study) | ||
| Total, all-cause mortality | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | ||
| Total, other adverse events | Perampanel (Placebo During Core Study) | 104 | 333 |
| Total, other adverse events | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | 201 | 664 |
| Total, serious adverse events | Perampanel (Placebo During Core Study) | 33 | 333 |
| Total, serious adverse events | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | 57 | 664 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) vs Perampanel (Placebo During Core Study): serious adverse events |
Source 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/NCT00360412
GET https://conductscience.org/api/trials/v1/NCT00360412/results?page=2