Clinical Trial: Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy

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

Official Title: Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy

Brief Summary: In this trial, the potential anti-epileptic effect of low dose fenfluramine in Lennox Gastaut epilepsy will be studied. An exploratory dose finding add-on trial is proposed. At baseline and at the end of the study, ECG and ultrasound of the heart will be performed as part of the safety follow up.

Detailed Summary:
Sponsor: Katholieke Universiteit Leuven

Current Primary Outcome: Efficacy of add-on FFA in Lennox Gastaut epilepsy: Number of responders and seizure free patients at each FFA dosage (0,2 or 0,4 or 0,8 mg/kg/day) [ Time Frame: up to 20 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Seizure frequency change per patient and per major seizure type (Tonic Clonic Seizures (TCS), Tonic Seizures (TS), Atonic Seizures (AS), Focal Seizures (FS)) [ Time Frame: 20 weeks ]
  • Adverse events (cardiac and general) [ Time Frame: 20 weeks ]
  • Sleep quality : 10 point scale instrument to score sleep quality [ Time Frame: 20 weeks ]
  • CGI (clinical global impression) scale at last visit , by patient/caregiver and treating physician [ Time Frame: 20 weeks ]


Original Secondary Outcome:

  • Seizure frequency change per patient and per major seizure type (Tonic Clonic Seizures (TCS), Tonic Seizures (TS), Atonic Seizures (AS), Focal Seizures (FS)) [ Time Frame: 20 weeks ]
  • Adverse events (cardiac and general) [ Time Frame: 20 weeks ]
  • Sleep quality [ Time Frame: 20 weeks ]
  • CGI (clinical global impression) scale at last visit , by patient/caregiver and treating physician [ Time Frame: 20 weeks ]


Information By: Katholieke Universiteit Leuven

Dates:
Date Received: January 12, 2016
Date Started: January 2016
Date Completion: March 2017
Last Updated: August 16, 2016
Last Verified: August 2016