Perampanel for Treatment of Adults With Refractory Focal Epilepsy : a Pilot Study.

Browse trials for

• Epilepsy 1,805
• Epilepsies, Partial 254

Keywords

• Focal epilepsy, Perampanel

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 8 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Lead sponsor

Mid-Atlantic Epilepsy and Sleep Center, LLC is the lead sponsor of 9 studies on the registry; none are open to participants now.

Study arms

• Active comparator
  phenobarbital

  After 12 weeks of baseline observation on phenobarbital medication, the treatment with perampanel will introduced as "add on" medication.

  Drug: perampanel

• Active comparator
  valproate

  After 12 weeks of baseline observation on valproate medication, the treatment with perampanel will introduced as "add on" medication.

  Drug: perampanel

• Active comparator
  lamotrigine

  After 12 weeks of baseline observation on lamotrigine medication, the treatment with perampanel will introduced as "add on" medication.

  Drug: perampanel

• Active comparator
  levetiracetam

  After 12 weeks of baseline observation on levetiracetam medication, the treatment with perampanel will introduced as "add on" medication.

  Drug: perampanel

• Active comparator
  zonisamide

  After 12 weeks of baseline observation on zonisamide medication, the treatment with perampanel will introduced as "add on" medication.

  Drug: perampanel

• Active comparator
  pregabalin

  After 12 weeks of baseline observation on pregabaline medication, the treatment with perampanel will introduced as "add on" medication.

  Drug: perampanel

• Active comparator
  lacosamide

  After 12 weeks of baseline observation on lacosasmide medication, the treatment with perampanel will introduced as "add on" medication.

  Drug: perampanel

• Active comparator
  clobazam

  After 12 weeks of baseline observation on clobazam medication, the treatment with perampanel will introduced as "add on" medication.

  Drug: perampanel

• Active comparator
  ezogabine

  After 12 weeks of baseline observation on ezogabine medication, the treatment with perampanel will introduced as "add on" medication.

  Drug: perampanel

• Active comparator
  eslicarbazepine

  After 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication.

  Drug: perampanel

• Active comparator
  topiramate

  After 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication.

  Drug: perampanel

• Active comparator
  tiagabine

  After 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication.

  Drug: perampanel

Interventions

• Drugperampanel

  Each group of 6 patients will be followed for 12 weeks of baseline observation on baseline medication. Seizure frequency will be counted, using subjects' self-reported seizure diaries. Perampanel will be titrated to 8-12 mg/day, with the final dose determined by side effects and tolerability of Perampanel at 8-12 mg/day doses. Titration will occur at the rate of 2 mg/week or two weeks, as tolerated.

  Also known as: Fycompa

Primary outcomes

1. responder rate

   responder rate, defined by \>75% seizure frequency reduction. Average seizure frequency per 4 weeks will be compared between the 12 weeks of "PMP+" maintenance treatment and 12 weeks of baseline.

   Time frame: 12 weeks

2. seizure freedom rate

   seizure freedom rate. Proportion of responders and of subjects with seizure freedom in each treatment arm will be compared with historical data of 75% seizure reduction from pivotal phase 3 studies for which such data is publicly available

   Time frame: 12 weeks

3. treatment discontinuation rate

   To evaluate the safety and tolerability of each perampanel+ combination with treatment discontinuation rate as the primary safety/tolerability outcome measure

   Time frame: 12 weeks

Individual participant data

Plan to share: Undecided