Phase 4
N=54
Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures
Partial Onset Seizures · Secondarily Generalized Seizures · Primary Generalized Tonic-Clonic Seizures
Bottom Line
View on ClinicalTrials.gov: NCT03288129 ↗Enrolled (actual)
54
Serious AEs
7.4%
Results posted
May 2022
Primary outcome: Primary: Percentage of Participants Remaining on Perampanel Treatment at 3 Months After the Initiation of Treatment — 85.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Perampanel (Drug)
- Age
- Pediatric, Adult, Older Adult · 4+ yrs
- Sex
- All
- Sponsor
- Eisai Inc.
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Remaining on Perampanel Treatment at 3 Months After the Initiation of Treatment |
85.2 | — |
| PRIMARY Percentage of Participants Remaining on Perampanel Treatment at 6 Months After the Initiation of Treatment |
68.5 | — |
| PRIMARY Percentage of Participants Remaining on Perampanel Treatment at 9 Months After the Initiation of Treatment |
63.0 | — |
| PRIMARY Percentage of Participants Remaining on Perampanel Treatment at 12 Months After the Initiation of Treatment |
51.9 | — |
| SECONDARY Percentage of Participants Who Achieved Seizure-free Status During the Maintenance Period |
19.2 | — |
| SECONDARY Percentage of Participants Who Achieved 3-month Seizure-free Status During the Maintenance Period |
34.6 | — |
| SECONDARY Percentage of Participants Who Achieved 6-month Seizure-free Status During the Maintenance Period |
23.1 | — |
| SECONDARY Percentage of Participants Who Received Perampanel as a First Adjunctive Therapy and Converted to Perampanel Monotherapy |
28.8 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAE) |
48 | — |
| SECONDARY Number of Participants With Treatment-emergent Serious Adverse Events (SAE) |
4 | — |
Summary
This study will assess the retention rate of perampanel when given as monotherapy or first adjunctive therapy in participants with partial-onset seizures or primary generalized tonic clonic seizures. The study consists of 4 periods: a Screening Period (to start no earlier than 6 weeks before the first dose of study drug), a Titration Period (up to 13 weeks), a Maintenance Period (39 weeks), and a Follow-Up Period (4 weeks).
Eligibility Criteria
Inclusion Criteria
- Participants will be male or female and no younger than 4 years of age and be able to swallow perampanel tablets.
- Participants must have a diagnosis of epilepsy with POS with or without SGS or with PGTCS. Either of the following must have occurred to support an epilepsy diagnosis:
- At least two unprovoked (or reflex) seizures occurring greater than 24 hours apart
- One unprovoked (or reflex) seizure with Electroencephalography (EEG) evidence of seizures
- Participants who receive perampanel as a first adjunctive therapy must currently have been treated with stable doses of monotherapy with an anti-epileptic drug (AED) for 8 weeks prior to Visit 2 (Week 0), have not previously received adjunctive AED treatment, and must, in the investigator's judgement, be in need of initial adjunctive therapy after failure to control seizures with AED monotherapy, at the optimal dose and duration.
- Participants who receive perampanel as monotherapy, who were newly diagnosed (treatment naïve), following the defined diagnosis of epilepsy.
- Participants who are currently receiving monotherapy treatment may receive perampanel as monotherapy if, in the investigator's judgment, the participant may benefit from a change in monotherapy treatment. Participants must not have previously received adjunctive AED treatment.
- If antidepressants or antianxiety drugs are used, participants must be on a stable dose regimen of these drugs during the 8 weeks before Visit 2 (Week 0).
Exclusion Criteria
- Participants should not have previously received or currently be receiving perampanel.
- Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta human chorionic gonadotropin [β-hCG] or hCG test with a minimum sensitivity of 25 International Units per liter [IU/L] or equivalent units of β-hCG or hCG); a separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
- Females of childbearing potential who:
- Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
- Total abstinence (if it is their preferred and usual lifestyle)
- An intrauterine device or intrauterine hormone-releasing system
- An oral contraceptive (with additional barrier method if using contraceptive containing levonorgestrel); participant must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation
- Have a vasectomized partner with confirmed azoospermia
- Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation For sites outside of the European Union, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, i.e, double barrier methods of contraception such as condom plus diaphragm or cervical/vault cap with spermicide.
NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
- Presence of or previous history of Lennox-Gastaut syndrome
- Presence of non-motor simple partial seizures only
- A history of status epilepticus within 1 year before Screening Visit (Visit 1)
- Participants on antipsychotics or who have psychotic disorder(s) or unstable recurrent affective disorder(s) with a history of attempted suicide within 1 year before Screening Visit (Visit 1)
- Presenc
Data sourced from ClinicalTrials.gov (NCT03288129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.