YKP3089 Trial as Adjunctive Therapy in Subjects with Partial Seizures

• Research type

  Research Study

• Full title

  A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Trial of YKP3089 as Adjunctive Therapy in Subjects with Partial Onset Seizures, with Optional Open-Label Extension

• IRAS ID

  136942

• Contact name

  Martin Brodie

• Contact email

  Martin.Brodie@glasgow.ac.uk

• Sponsor organisation

  SK Life Science Inc

• Eudract number

  2013-001858-10

• Research summary

  Summary of Results

  This study was carried out by SK Life Science Inc. in order to determine if their study drug YKP3089 could help epilepsy patients by reducing the frequency of seizures over time, when given at dosage of 100 – 400 mg each day with up to three other marketed anti-epileptic drugs (AEDs). The study also looked into the safety and tolerability of YKP3089. The study was carried out at 107 research centres worldwide, with 437 participants aged 18-70 years old taking part.

  In the US and rest of the world:
  • there were statistically significant reductions in the average seizure frequency per 28 days during the double-blind treatment period at all YKP3089 dosage levels compared to placebo • the responses in the 200 mg/day treatment group were compared with the placebo group and an average 55.0% reduction in seizure frequency was noted • the results from the 400 mg/day treatment group were compared with the placebo group, and an average 55.0% reduction in seizure frequency was noted • the results from the 100 mg/day treatment group were compared with the placebo group and a median 35.5% reduction in seizure frequency was noted • YKP3089 significantly increased the responder rate (≥50% reduction in seizure frequency) during the double-blind treatment period, 44 participants (40.7%) were responders in the 100mg/day group, 63 participants were responders in the 200mg/day group and 67 participants were responders in the 400mg/day group, in comparison to 23 participants (21.7%) were responders in the placebo group In Europe, Australia, New Zealand and South Africa:
  • Compared with placebo, there was a statistically significant difference in responder rate for each of the YKP3089 treatment groups during the maintenance phase o In the placebo group, 26 participants (25.5%) had a ≥ 50% reduction in the frequency of seizures o In the 200 mg/day treatment group, responses were compared with those in the placebo group and 55 participants (56.1%) had a ≥ 50% reduction in the frequency of seizures o In the 400 mg/day treatment group, responses were compared with those in the placebo group and 61 participants (64.2%) had a ≥ 50% reduction in the frequency of seizures o In the 100 mg/day treatment group, responses were compared with those in the placebo group and 41 participants (40.2%) had a ≥ 50% reduction in the frequency of seizures • YKP3089, at doses of 200 mg/day and 400 mg/day, significantly reduced the average seizure frequency per 28 days during the maintenance phase of treatment. There was a 41.5% reduction in the 100mg/day group, 56.5% reduction in the 200mg/day group and 63% reduction in the 400mg/day group, in comparison to a 27% reduction in the placebo group

• REC name

  Scotland A: Adults with Incapacity only

• REC reference

  13/SS/0224

• Date of REC Opinion

  20 Dec 2013

• REC opinion

  Further Information Favourable Opinion