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NCT02427607

An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects

Completed Phase 3 Results posted Last updated 2 July 2018
What this trial tests

Phase 3 trial testing Perampanel in Epilepsy in 7 participants. Completed in 9 November 2016.

Timeline
12 May 2015
Primary endpoint
21 September 2016
9 November 2016

Quick facts

Lead sponsorEisai Co., Ltd.
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment7
Start date12 May 2015
Primary completion21 September 2016
Estimated completion9 November 2016
Sites8 locations across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Eisai Co., Ltd. — full company profile →

Who can join

12 and older, any sex, with Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel Primary · From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months

Safety was assessed by monitoring adverse events (AEs), withdrawal from treatment, clinical laboratory tests (chemistry), vital signs, and weight. TEAEs were defined as AEs that emerged from the first dose of study drug to the last visit of Study 341 or on or after 30 days since the last dose of study drug in Study 341, whichever comes later, having been absent at pretreatment (Baseline of Study 332). A markedly abnormal clinical chemistry laboratory value was defined as a laboratory result that worsened in severity to meet modified National Cancer Institute (NCI) toxicity criteria of Grade 2

Non-Serious TEAEs
GroupValue95% CI
Perampanel6
Treatment-related TEAEs
GroupValue95% CI
Perampanel0
Severe TEAEs
GroupValue95% CI
Perampanel0
TEAEs leading to study drug dose adjustment
GroupValue95% CI
Perampanel0
Serious TEAE
GroupValue95% CI
Perampanel0

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Perampanel
Serious: 0/7 (0%)
Deaths: 0/7
Other adverse events (8 terms — click to expand)

ReactionSystemPerampanel
NasopharyngitisInfections and infestations
InfluenzaInfections and infestations
FallInjury, poisoning and procedural complications
Head injuryInjury, poisoning and procedural complications
Humerus fractureInjury, poisoning and procedural complications
Diabetes mellitusMetabolism and nutrition disorders
HypercholesterolaemiaMetabolism and nutrition disorders
HyperuricaemiaMetabolism and nutrition disorders

Data from ClinicalTrials.gov NCT02427607 adverse events section.

Sponsor's own description

To evaluate the safety and tolerability of perampanel given as an adjunctive therapy in participants with epilepsy. This study will be continued until perampanel is commercially available.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Exploring the Evidence for Broad-Spectrum Effectiveness of Perampanel: A Systematic Review of Clinical Data in Generalised Seizures.
    Trinka E, Lattanzi S, Carpenter K, Corradetti T, et al · · 2021 · cited 29× · PMID 34232492 · DOI 10.1007/s40263-021-00831-y
  2. Assessment of the long-term efficacy and safety of adjunctive perampanel in tonic-clonic seizures: Analysis of four open-label extension studies.
    Rektor I, Krauss GL, Inoue Y, Kaneko S, et al · · 2020 · cited 15× · PMID 32645213 · DOI 10.1111/epi.16573

Verify or expand the search:

Other trials of Perampanel

Trials testing the same drug.

Other recruiting trials for Epilepsy

Currently open trials in the same condition.

Other Eisai Co., Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02427607.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing