Clinical Trial: Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 Years of Age With Inadequately Control

Brief Summary: This study is being conducted to demonstrate that perampanel given as adjunctive anti-epileptic treatment is superior to placebo in reducing the number of drop seizures in participants with inadequately controlled seizures associated with Lennox-Gastaut Syndrome (LGS).

Detailed Summary: This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study of perampanel as adjunctive therapy in participants with inadequately controlled seizures associated with LGS. The study will consist of 3 phases: Prerandomization (4 to 8 weeks), Randomization (22 weeks), and Extension (56 weeks).
Sponsor: Eisai Inc.

Current Primary Outcome: Median percent change in drop seizure frequency per 28 days during double-blind treatment (Titration Period and Maintenance Period) relative to the Prerandomization Phase [ Time Frame: up to 18 weeks ]

Drop seizures are defined as drop attacks or spells involving the entire body, trunk, or head that lead to a fall, injury, slumping in a chair, or the participant's head hitting a surface, or that could lead to a fall or injury, depending on the participant's position at the time of the attack or spell. Percent change from Baseline is calculated as: ([post-Baseline value minus the Baseline value] / Baseline value) * 100.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Median percent change in total seizure frequency per 28 days during double-blind treatment (Titration Period and Maintenance Period) relative to the Prerandomization Phase [ Time Frame: up to 18 weeks ]
    Percent change from Baseline is calculated as: ([post-Baseline value minus the Baseline value] / Baseline value) * 100.
  • Number of participants with 50% responder rate in the Maintenance Period of the double-blind treatment phase relative to the Prerandomization Phase for drop seizures [ Time Frame: up to 12 weeks ]
    Drop seizures are defined as drop attacks or spells involving the entire body, trunk, or head that lead to a fall, injury, slumping in a chair, or the participant's head hitting a surface, or that could lead to a fall or injury, depending on the participant's position at the time of the attack or spell. The 50% responder rate is defined as the number of participants who have at least a 50% reduction in seizure frequency during the Maintenance Period relative to the Prerandomization Phase.
  • Number of participants with 50% responder rate in the Maintenance Period of the double-blind treatment phase relative to the Prerandomization Phase for total seizures [ Time Frame: up to 12 weeks ]
    The 50% responder rate is defined as the number of participants who have at least a 50% reduction in seizure frequency during the Maintenance Period relative to the Prerandomization Phase.
  • Median percent change in non-drop seizure frequency per 28 days during double-blind treatment (Titration Period and Maintenance Period) relative to the Prerandomization Phase [ Time Frame: up to 18 weeks ]
    Non-drop seizures are defined as non-drop attacks or spells. Drop attacks and spells involve the entire body, trunk, or head and lead to a fall, injury, slumping in a chair, or the participant's head hitting a surface, or could lead to a fall or injury, depending on the participant's position at the time of the attack or spell. Percent change from Baseline is calculated as: ([post-Baseline value minus the Baseline value] / Baseline value) * 100.
  • Number of participants with a 50% responder rate in the Maintenance Period of the double-blind treatment phase relative to the Prerandomization Phase for non-drop seizures [ Time Frame: up to 12 weeks ]
    The 50% responder rate is defined as the number of participants who have at least a 50% reduction in seizure frequency during the Maintenance Period relative to the Prerandomization Phase. Non-drop seizures are defined as non-drop attacks or spells. Drop attacks and spells involve the entire body, trunk, or head and lead to a fall, injury, slumping in a chair, or the participant's head hitting a surface, or could lead to a fall or injury, depending on the participant's position at the time of the attack or spell.
  • Physicians' global evaluation of the participant's overall changes in symptoms at the end of double-blind treatment [ Time Frame: up to 18 weeks ]
    The physician evaluated symptoms using a 7-point Likert scale: 1 = very much improved; and 7 = very much worse.
  • Number of participants with any adverse events (AE) and any Serious adverse events (SAE) [ Time Frame: up to 86 weeks ]
    For this study, the criteria for identifying AEs are: any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product; any new disease or exacerbation of an existing disease; any deterioration in nonprotocol-required measurements of a laboratory value or other clinical test (eg, electrocardiogram [ECG] or X-ray) that results in symptoms, a change in treatment, or discontinuation of study drug; recurrence of an intermittent medical condition (eg, headache) not present pretreatment (Baseline); an abnormal laboratory test result should be considered an AE if the identified laboratory abnormality leads to any type of intervention, withdrawal of study drug, or withholding of study drug, whether prescribed in the protocol or not.
  • Model-derived average perampanel concentrations at steady state (Cav,ss) during the Maintenance Period of the Core Study [ Time Frame: Days 43, 78, and 126; upon early discontinuation ]
    The average concentration of perampanel in plasma will be measured at the time a "steady state" has been achieved (rates of drug administration and drug elimination are equal).
  • Proportion of participants with 75% and 100% responder rates in the Maintenance Period of the double-blind treatment phase relative to the Prerandomization Phase for drop, non-drop, and total seizures [ Time Frame: up to 12 weeks ]


Original Secondary Outcome: Same as current

Information By: Eisai Inc.

Dates:
Date Received: July 13, 2016
Date Started: December 2016
Date Completion: February 2020
Last Updated: March 15, 2017
Last Verified: February 2017