Clinical Trial: A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications

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

Official Title: A Double-blind, Randomized, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clo

Brief Summary: Evaluating efficacy & safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration of study drug administration is 28 weeks. Eligible subjects may choose to enter the open-label extension study after completion.

Detailed Summary:
Sponsor: UCB BIOSCIENCES, Inc.

Current Primary Outcome: Time to the second primary generalized tonic clonic (PGTC) seizure during the 24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) [ Time Frame: 24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) ]

Time to the second primary generalized tonic clonic (PGTC) seizure during the 24-week Treatment Period.


Original Primary Outcome: Time to the second primary generalized tonic clonic (PGTC) seizure during the 24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) [ Time Frame: 24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) ]

Current Secondary Outcome:

  • Seizure freedom for primary generalized tonic clonic (PGTC) seizures during the 24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) [ Time Frame: 24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) ]
    Seizure freedom for PGTC seizures for the 24-week Treatment Period
  • The percent change in primary generalized tonic clonic (PGTC) seizure frequency per 28 days during the first 6 weeks of the Treatment Period (Titration Phase) relative to the Combined Baseline (combined 12-week Historical and 4-week Prospective Baseline) [ Time Frame: During the first 6 weeks of the Treatment Period (Titration Phase) relative to the Combined Baseline (combined 12-week Historical and 4-week Prospective Baseline) ]
    The percent change in PGTC seizure frequency per 28 days from the Combined Baseline (combined 12-week Historical and 4-week Prospective Baseline) to the first 6 weeks of the Treatment Period.
  • The percent change in primary generalized tonic clonic (PGTC) seizure frequency per 28 days during the Treatment Period relative to the Combined Baseline (combined 12-week Historical and 4-week Prospective Baseline) [ Time Frame: During the Treatment Period relative to the Combined Baseline (combined 12-week Historical and 4-week Prospective Baseline) ]
    The percent change in PGTC seizure frequency per 28 days from the Combined Baseline (combined 12-week Historical and 4-week Prospective Baseline) to the 24-week Treatment Period.
  • Time to the first primary generalized tonic clonic (PGTC) seizure during the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) [ Time Frame: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) ]
    Time to the first PGTC seizure during the 24-week Treatment Period.


Original Secondary Outcome:

  • Seizure freedom for primary generalized tonic clonic (PGTC) seizures during the 24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) [ Time Frame: 24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) ]
  • The percent change in primary generalized tonic clonic (PGTC) seizure frequency per 28 days from the Combined Baseline (combined 12-week Historical and 4-week Prospective Baseline) to the first 6 weeks of the Treatment Period [ Time Frame: From the Combined Baseline (combined 12-week Historical and 4-week Prospective Baseline) to the first 6 weeks of the Treatment Period ]
  • The percent change in primary generalized tonic clonic (PGTC) seizure frequency per 28 days from the Combined Baseline (combined 12-week Historical and 4-week Prospective Baseline) to the 24-week Treatment Period [ Time Frame: From the Combined Baseline (combined 12-week Historical and 4-week Prospective Baseline) to the 24-week Treatment Period ]
  • Time to the first primary generalized tonic clonic (PGTC) seizure 24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) [ Time Frame: 24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) ]


Information By: UCB Pharma

Dates:
Date Received: March 31, 2015
Date Started: April 2015
Date Completion: January 2019
Last Updated: April 26, 2017
Last Verified: April 2017