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 ]
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