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
Status: | Recruiting |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 2/27/2019 |
Start Date: | August 23, 2017 |
End Date: | June 3, 2020 |
Contact: | Eisai Medical Information |
Email: | esi_medinfo@eisai.com |
Phone: | 1-888-274-2378 |
Multicenter, Open-Label 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
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 (13 weeks), a
Maintenance Period (39 weeks), and a Follow-Up Period (4 weeks).
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 (13 weeks), a
Maintenance Period (39 weeks), and a Follow-Up Period (4 weeks).
Inclusion Criteria:
- Participants will be male or female and no younger than 12 years of age.
- Participants must have a diagnosis of epilepsy with partial-onset seizures (POS) (with
or without secondarily generalized seizures [SG]) or with primary generalized tonic
clonic seizures (PGTC) according to the International League Against Epilepsy's (ILAE)
Classification of Epileptic Seizures (1981).
- Participants who receive perampanel as a first adjunctive therapy must currently have
been treated with stable doses of monotherapy for 8 weeks prior to Visit 2 (Week 0),
have not previously received adjunctive anti-epileptic drug (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), must have experienced 2 or more well documented seizures within the
past year, with at least 24 hours between these seizures.
- 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 levogesterol); 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, ie, 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 (ie,
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)
- Presence of a progressive central nervous system (CNS) disease, including degenerative
CNS diseases and progressive tumors
- Concomitant use of barbiturates (except for seizure control indication and
premedication for electroencephalogram) and benzodiazepines (except for seizure
control indication) within 8 weeks prior to Visit 2 (Week 0)
- Use of intermittent rescue benzodiazepines (ie, 1 to 2 doses over a 24-hour period is
considered a one time rescue) 2 or more times in the 8-week period prior to Visit 2
(Week 0)
- Severe renal insufficiency (defined by estimated glomerular filtration rate of < 30
milliliters per minute [mL/min]) or participants who receive hemodialysis
- Evidence of clinically significant disease (eg, cardiac, respiratory,
gastrointestinal, renal disease, hepatic disease) that in the opinion of the
investigator(s) could affect the participant's safety or study conduct NOTE: Stable
elevation of liver enzymes, alanine aminotransferase and aspartate aminotransferase
due to concomitant medication(s) will be allowed if they are less than 3 times the
upper limits of normal.
- Hypersensitivity to perampanel or any excipients
- Participants with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption
- Participants who are participating in other interventional clinical trial
- Participant who are judged to have inadequate cognitive ability for participation in
the study (intelligence quotient < 80 or investigator judgment)
- Any suicidal ideation with intent with or without a plan, at the time of or within 6
months of screening, as indicated by answering "Yes" to questions 4 and 5 on the
Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS)
- Any lifetime suicidal behavior based on the C-SSRS
We found this trial at
24
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