Clinical Trial: Efficacy Study of Acetazolamide Versus Diazepam in Continuous Spike and Wave/Landau-Kleffner Syndrome

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Non-inferiority Prospective Randomized Trial of Acetazolamide Versus Diazepam in Patients With Continuous Spike and Wave in Sleep (CSWS)/Landau Kleffner Syndrome (LKS)

Brief Summary: The purpose of this study is to compare the effectiveness of the medications acetazolamide and diazepam in the treatment of continuous spike wave in sleep (CSWS) and Landau-Kleffner syndrome (LKS).

Detailed Summary:
Sponsor: Mayo Clinic

Current Primary Outcome: Spike wave index (SWI) reduction seen in children on acetazolamide [ Time Frame: within first 4-6 weeks after starting therapy with acetazolamide ]

Similar SWI reductions (percentage) comparing acetazolamide and diazepam


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Improvement in behaviors (attention, hyperactivity) [ Time Frame: within 4-8 weeks of initiation of acetazolamide ]
  • Improvement in cognitive regression [ Time Frame: within 4-8 weeks of initiation of acetazolamide ]
  • Long term tolerability to acetazolamide [ Time Frame: 6 months ]
    Expect minimal side effects at follow up at 6 months
  • Short-term tolerability of acetazolamide vs diazepam [ Time Frame: 4-8 weeks of start of medications ]
    Expect improved side effect profile of acetazolamide compared to diazepam at short-term follow up


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: September 13, 2016
Date Started: September 2016
Date Completion: July 2019
Last Updated: September 13, 2016
Last Verified: September 2016