Trial · NCT03201900
Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Participants With Partial Onset Seizures (Including Secondarily Generalized Seizures (FREEDOM Study)
NCT03201900, Phase 3, Completed, Eisai Co., Ltd.; results first posted 2020-02-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Participants With Partial Onset Seizures (Including Secondarily Generalized Seizures (FREEDOM Study). Trials, record NCT03201900. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03201900
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Participants With Partial Onset Seizures (Including Secondarily Generalized Seizures (FREEDOM Study)
- NCT number
- NCT03201900
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 91 participants, actual
- Lead sponsor
- Eisai Co., Ltd.
- Conditions
- Partial Onset Seizures
- Interventions
- E2007
- First posted
- 2017-06-28
- Last updated
- 2021-08-05
- Results first posted
- 2020-02-25
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Partial-onset Seizures (POS) Who Achieved Seizure-free Status During the 26-week Maintenance Period of 4 mg Perampanel | 26 weeks in Maintenance Period of 4 mg perampanel | A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during 26-week Maintenance Period of 4 mg perampanel. |
| Secondary | Percentage of Participants With POS Who Achieved Seizure-free Status During the 26-week Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel | 26 weeks in Maintenance Period of 4 or 8 mg perampanel | A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during the 26-week Maintenance Period of last evaluated dose of 4 or 8 mg perampanel. |
| Secondary | Percentage of Participants With POS Who Achieved Seizure-free Status During the 52-week Treatment Phase (26-week Maintenance Period Plus 26-week Extension Phase) of 4 mg of Perampanel | 52-week (Maintenance Period of 4 mg perampanel + Extension Phase of 4 mg perampanel) | A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during 52-weeks treatment of 4 mg perampanel. |
| Secondary | Percentage of Participants With POS Who Achieved Seizure-free Status During the 52-week of Treatment Phase (26-week Maintenance Period Plus 26-week Extension Phase) of Last Evaluated Dose of 4 or 8 mg Perampanel | 52-week (Maintenance Period of last evaluated dose of 4 or 8 mg perampanel + Extension Phase of 4 or 8 mg perampanel) | A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during the 52-week treatment of last evaluated dose of 4 or 8 mg perampanel. |
| Secondary | Time to Onset of First Seizure From the First Dose of Study Drug in the Maintenance Period of 4 mg Perampanel | From the first dose of study drug in the Maintenance Period (Week 6) up to the first seizure onset (up to 150 weeks) | Time to onset of first seizure was defined as the period from the first dose of study drug in the 4 mg Maintenance Period to the onset of first seizure. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. |
| Secondary | Time to Onset of First Seizure From the First Dose of Study Drug in the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel | From the first dose of study drug in the Maintenance Period (Week 6) up to the first seizure onset (up to 150 weeks) | Time to onset of first seizure was defined as the period from the first dose of study drug in the 4 mg or 8 mg Maintenance Period to the onset of first seizure. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. |
| Secondary | Time to Withdrawal From the First Dose of Study Drug in the Maintenance Period of 4 mg Perampanel | From the first dose of study drug in the Maintenance Period (Week 6) up to the date of first withdrawal, regardless of reason (up to 150 weeks) | Time to withdrawal from the study was defined as the period from the first dose of study drug in the 4 mg Maintenance Period to the date of withdrawal from study, regardless of reason. |
| Secondary | Time to Withdrawal From the First Dose of Study Drug in the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel | From the first dose of study drug in the Maintenance Period (Week 6) up to the date of first withdrawal, regardless of reason (up to 150 weeks) | Time to withdrawal from the study was defined as the period from the first dose of study drug in the 4 mg or 8 mg Maintenance Period to the date of withdrawal from study, regardless of reason. |
| Secondary | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Event (TESAEs), and TEAEs Leading to Discontinuation of the Study Drug | From baseline up to 28 days after last dose of study drug (up to 160 weeks) |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Partial-onset Seizures (POS) Who Achieved Seizure-free Status During the 26-week Maintenance Period of 4 mg Perampanel | 26 weeks in Maintenance Period of 4 mg perampanel | Modified intent to treat (mITT) set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With POS Who Achieved Seizure-free Status During the 26-week Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel | 26 weeks in Maintenance Period of 4 or 8 mg perampanel | mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With POS Who Achieved Seizure-free Status During the 52-week Treatment Phase (26-week Maintenance Period Plus 26-week Extension Phase) of 4 mg of Perampanel | 52-week (Maintenance Period of 4 mg perampanel + Extension Phase of 4 mg perampanel) | mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With POS Who Achieved Seizure-free Status During the 52-week of Treatment Phase (26-week Maintenance Period Plus 26-week Extension Phase) of Last Evaluated Dose of 4 or 8 mg Perampanel | 52-week (Maintenance Period of last evaluated dose of 4 or 8 mg perampanel + Extension Phase of 4 or 8 mg perampanel) | mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period. | percentage of participants | NUMBER |
| SECONDARY | Time to Onset of First Seizure From the First Dose of Study Drug in the Maintenance Period of 4 mg Perampanel | From the first dose of study drug in the Maintenance Period (Week 6) up to the first seizure onset (up to 150 weeks) | mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period. | weeks | MEDIAN |
| SECONDARY | Time to Onset of First Seizure From the First Dose of Study Drug in the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel | From the first dose of study drug in the Maintenance Period (Week 6) up to the first seizure onset (up to 150 weeks) | mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period. | weeks | MEDIAN |
| SECONDARY | Time to Withdrawal From the First Dose of Study Drug in the Maintenance Period of 4 mg Perampanel | From the first dose of study drug in the Maintenance Period (Week 6) up to the date of first withdrawal, regardless of reason (up to 150 weeks) | mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period. | weeks | MEDIAN |
| SECONDARY | Time to Withdrawal From the First Dose of Study Drug in the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel | From the first dose of study drug in the Maintenance Period (Week 6) up to the date of first withdrawal, regardless of reason (up to 150 weeks) | mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period. | weeks | MEDIAN |
| SECONDARY | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Event (TESAEs), and TEAEs Leading to Discontinuation of the Study Drug | From baseline up to 28 days after last dose of study drug (up to 160 weeks) | The safety analysis set was the group of participants who signed informed consent, received at least one dose of study drug and had at least one postdose safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Partial-onset Seizures (POS) Who Achieved Seizure-free Status During the 26-week Maintenance Period of 4 mg Perampanel | Perampanel | 63.0 | 95% Confidence Interval 50.9 to 74.0 | percentage of participants | |
| Percentage of Participants With POS Who Achieved Seizure-free Status During the 26-week Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel | Perampanel | 74.0 | 95% Confidence Interval 62.4 to 83.5 | percentage of participants | |
| Percentage of Participants With POS Who Achieved Seizure-free Status During the 52-week Treatment Phase (26-week Maintenance Period Plus 26-week Extension Phase) of 4 mg of Perampanel | Perampanel | 32.9 | 95% Confidence Interval 22.3 to 44.9 | percentage of participants | |
Percentage of Participants With POS Who Achieved Seizure-free Status During the 52-week of Treatment Phase (26-week Maintenance Period Plus 26-week Extension Phase) of Last Evaluated Dose of 4 or 8 mg Perampanel | Perampanel | 42.5 | 95% Confidence Interval 31.0 to 54.6 | percentage of participants | |
| Time to Onset of First Seizure From the First Dose of Study Drug in the Maintenance Period of 4 mg Perampanel | Perampanel | NA | 95% Confidence Interval 37.4 to NA | weeks | |
| Time to Onset of First Seizure From the First Dose of Study Drug in the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel | Perampanel | NA | 95% Confidence Interval NA to NA | weeks | |
| Time to Withdrawal From the First Dose of Study Drug in the Maintenance Period of 4 mg Perampanel | Perampanel | NA | 95% Confidence Interval 27.4 to NA | weeks | |
| Time to Withdrawal From the First Dose of Study Drug in the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel | Perampanel | NA | 95% Confidence Interval 27.4 to NA | weeks | |
| Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Event (TESAEs), and TEAEs Leading to Discontinuation of the Study Drug | Perampanel | TEAEs | 74 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Event (TESAEs), and TEAEs Leading to Discontinuation of the Study Drug | Perampanel | TESAEs | 13 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Phase (Up to 62 Weeks) | STARTED | Perampanel | 91 | |
| Treatment Phase (Up to 62 Weeks) | Treated | Perampanel | 89 | |
| Treatment Phase (Up to 62 Weeks) | COMPLETED | Perampanel | 54 | |
| Treatment Phase (Up to 62 Weeks) | NOT COMPLETED | Perampanel | 37 | |
| Extension Phase (From Week 63 to 156) | STARTED | Perampanel | 46 | |
| Extension Phase (From Week 63 to 156) | COMPLETED | Perampanel | 38 | |
| Extension Phase (From Week 63 to 156) | NOT COMPLETED | Perampanel | 8 |
Source ClinicalTrials.gov
Adverse events143
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 | Auditory disorder | Ear and labyrinth disorders | Perampanel | 1 | 89 | 1 |
| other | Hypoacusis | Ear and labyrinth disorders | Perampanel | 1 | 89 | 1 |
| other | Meniere's disease | Ear and labyrinth disorders | Perampanel | 1 | 89 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Perampanel | 2 | 89 | 2 |
| other | Vestibular disorder | Ear and labyrinth disorders | Perampanel | 1 | 89 | 1 |
| other | Blepharitis | Eye disorders | Perampanel | 1 | 89 | 1 |
| other | Conjunctivitis allergic | Eye disorders | Perampanel | 1 | 89 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Perampanel | 4 | 89 | 6 |
| other | Stomatitis | Gastrointestinal disorders | Perampanel | 3 | 89 | 4 |
| other | Toothache | Gastrointestinal disorders | Perampanel | 3 | 89 | 7 |
1 to 10 of 143Source ClinicalTrials.gov
See all 143 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Perampanel | 0 | 89 |
| Total, other adverse events | Perampanel | 73 | 89 |
| Total, serious adverse events | Perampanel | 13 | 89 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34657389 | DERIVED |
Source PubMed
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/NCT03201900
GET https://conductscience.org/api/trials/v1/NCT03201900/events?page=2