A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures

Browse trials for

• Seizures 881

Keywords

• Partial-onset Seizures
• partial seizures
• seizure
• epilepsy

Seizures

881 studies on the registry are indexed under Seizures; 143 are open to participants now.

This study's enrollment of 940 is above the median of 64 across 610 interventional studies indexed under Seizures.

Lead sponsor

Eisai Co., Ltd. is the lead sponsor of 149 studies on the registry; 5 are open to participants now.

Study arms

• Experimental
  Perampanel

  Drug: Perampanel

• Placebo comparator
  Placebo

  Drug: Placebo

Interventions

• DrugPerampanel

  Core study: 4 milligram (mg) group- Week 0 Once daily 2 milligram per day (mg/day), Week 1 to Week 18 Once daily 4 mg/day; 8 mg group- Week 0 Once daily 2 mg/day, Week 1 Once daily 4 mg/day, Week 2 Once daily 6 mg/day, Week 3 to Week 18 Once daily 8 mg/day; 12 mg group- Week 0 Once daily 2 mg/day, Week 1 Once daily 4 mg/day, Week 2 Once daily 6 mg/day, Week 3 Once daily 8 mg/day, Week 4 Once daily 10 mg/day, Week 5 to Week 18 Once daily 12 mg/day. Extension study: 4 mg group- Week 19 to Week 22 Once daily 4 mg/day, Week 23 Once daily 6 mg/day, Week 24 Once daily 8 mg/day, Week 25 Once daily 10 mg/day, Week 26 to Week 75 or more Once daily 12 mg/day; 8 mg group- Week 19 to Week 22 Once daily 8 mg/day, Week 23 Once daily 10 mg/day, Week 24 to Week 75 or more Once daily 12 mg/day; 12 mg group- Week 19 to Week 75 or more Once daily 12 mg/day.

  Also known as: E2007

• DrugPlacebo

  Core study: Week 0 to Week 18 Once daily placebo. Extension study: Week 19 to Week 22 Once daily placebo, Week 23 Once daily perampanel 2 mg/day, Week 24 Once daily perampanel 4 mg/day, Week 25 Once daily perampanel 6 mg/day, Week 26 Once daily perampanel 8 mg/day, Week 27 Once daily perampanel 10 mg/day, Week 28 to Week 75 or more Once daily perampanel 12 mg/day.

Primary outcomes

1. Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline)

   Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. All partial seizure included simple partial seizures without motor signs, simple partial with motor signs, complex partial, and complex partial with secondary generalized seizures. A simple partial seizure takes place on one side of the brain. Usually, people experiencing a simple partial seizure do not lose consciousness or awareness. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain. The seizure affects people's awareness and may cause them to lose consciousness.

   Time frame: Baseline, Week 19

Secondary outcomes

1. Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF)

   Responder rate was percentage of participants with greater than or equal to (\>=) 50% reduction in seizure frequency during maintenance period of the randomization phase relative to prerandomization phase (baseline). If the reduction in seizure frequency is less than (\<) 50%, then the participants are considered as non-responders.

   Time frame: Baseline, Week 19

2. Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline)

   Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain and it affects awareness and may cause in loss of consciousness. Secondary generalized seizures begin in one part of the brain, but then spread to both sides of the brain.

   Time frame: Baseline, Week 19

3. Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores

   The investigator evaluated each participant for CGIC questionnaire to assess change in participant's disease clinical status from baseline. Assessment evaluated frequency of seizures, severity of seizures, occurrence of adverse events (AEs), and overall functional status of the participant using the 7-point scale. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Lower score indicated improvement and higher score indicated worsening.

   Time frame: Baseline, Week 19

Baseline characteristics

Publications

• Nishida T, Lee SK, Inoue Y, Saeki K, Ishikawa K, Kaneko S. Adjunctive perampanel in partial-onset seizures: Asia-Pacific, randomized phase III study. Acta Neurol Scand. 2018 Apr;137(4):392-399. doi: 10.1111/ane.12883. Epub 2017 Dec 17. PubMed 29250772 ↗