Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02726074 : Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Participants With Partial Onset Seizures
PhasePhase 4
AgesMin: 12 Years Max: N/A
Eligibility
Inclusion Criteria:

- Have a diagnosis of epilepsy with partial onset seizures with or without secondarily
generalized seizures according to the International League Against Epilepsy's
Classification of Epileptic Seizures (1981)

- Need an initial add-on therapy after failure to control seizures with the first or
further monotherapy at the optimal dose and duration

- Despite antiepileptic drug (AED) treatment within the last 8 weeks, participants must
have had greater than or equal to 2 partial onset seizures, and the interval between
those seizures should be more than 24 hours prior to Visit 1 (Week 0).

- Are currently being treated with stable doses of monotherapy for 8 weeks prior to
Visit 1 (Week 0) (Standard AEDs)

- If antidepressants or antianxiety drugs are used, participants must be receiving
stable doses and administrations of antidepressants or antianxiety drugs for 8 weeks
prior to Visit 1 (Week 0)

Exclusion Criteria:

- Females who are pregnant (positive ?-hCG test) or breastfeeding

- Presence of previous history of Lennox-Gastaut syndrome

- Presence of nonmotor simple partial seizures only

- Presence of primary generalized epilepsies or seizures such as absences and/or
myoclonic epilepsies

- A history of status epilepticus within 12 weeks before Visit 1 (Week 0)

- 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 Visit 1 (Week 0)

- 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 [EEG]) and benzodiazepines (except for seizure
control indication) within 8 weeks prior to Visit 1 (Week 0)

- Use of intermittent rescue benzodiazepines (ie, 1 to 2 doses over a 24-hr period
considered one-time rescue) 2 or more times in an 8-week period prior to Visit 1
(Week 0)

- Participant who is participating in other intervention clinical trial
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02726074      |      Link to official Clinicaltrials.gov listing
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