Trial Outcomes & Findings for Efficacy Study of Acetazolamide Versus Diazepam in Continuous Spike and Wave/Landau-Kleffner Syndrome (NCT NCT02904265)

NCT ID: NCT02904265

Last Updated: 2020-06-11

Results Overview

Expect improved side effect profile of acetazolamide compared to diazepam at short-term follow up

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 3 participants
• Primary outcome timeframe: 4-8 weeks of start of medications
• Results posted on: 2020-06-11

Participant Flow

Study closed due to only 3 participants recruited

Study closed due to only 3 participants recruited

Participant milestones

Measure	Diazepam Diazepam 0.5 mg/kg (up to maximum 20 mg) by mouth nightly. Duration of therapy is 4 weeks. Diazepam	Acetazolamide Acetazolamide 8-10 mg/kg (up to a maximum dose of 375 mg) by mouth (PO)divided twice daily X 1 week, then increased to 11-16 mg/kg (up to a maximum dose of 750 mg) by mouth divided twice daily thereafter. Duration of therapy is 4-8 weeks. Acetazolamide
Overall Study STARTED	1	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Diazepam Diazepam 0.5 mg/kg (up to maximum 20 mg) by mouth nightly. Duration of therapy is 4 weeks. Diazepam	Acetazolamide Acetazolamide 8-10 mg/kg (up to a maximum dose of 375 mg) by mouth (PO)divided twice daily X 1 week, then increased to 11-16 mg/kg (up to a maximum dose of 750 mg) by mouth divided twice daily thereafter. Duration of therapy is 4-8 weeks. Acetazolamide
Overall Study Physician Decision	1	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Diazepam n=1 Participants Diazepam 0.5 mg/kg (up to maximum 20 mg) by mouth nightly. Duration of therapy is 4 weeks.	Acetazolamide n=2 Participants Acetazolamide 8-10 mg/kg (up to a maximum dose of 375 mg) by mouth (PO)divided twice daily X 1 week, then increased to 11-16 mg/kg (up to a maximum dose of 750 mg) by mouth divided twice daily thereafter. Duration of therapy is 4-8 weeks. Acetazolamide	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=1 Participants	2 Participants n=2 Participants	3 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Age, Categorical >=65 years	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Age, Continuous	1 years n=1 Participants	2 years n=2 Participants	1.5 years n=3 Participants
Sex: Female, Male Female	0 Participants n=1 Participants	1 Participants n=2 Participants	1 Participants n=3 Participants
Sex: Female, Male Male	1 Participants n=1 Participants	1 Participants n=2 Participants	2 Participants n=3 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	1 participants n=1 Participants	2 participants n=2 Participants	2 participants n=3 Participants

PRIMARY outcome

Timeframe: 4-8 weeks of start of medications

Population: Study closed due to only 3 participants recruited

Expect improved side effect profile of acetazolamide compared to diazepam at short-term follow up

Outcome measures

Measure	Diazepam n=1 Participants Diazepam 0.5 mg/kg (up to maximum 20 mg) by mouth nightly. Duration of therapy is 4 weeks. Diazepam	Acetazolamide n=2 Participants Acetazolamide 8-10 mg/kg (up to a maximum dose of 375 mg) by mouth (PO)divided twice daily X 1 week, then increased to 11-16 mg/kg (up to a maximum dose of 750 mg) by mouth divided twice daily thereafter. Duration of therapy is 4-8 weeks. Acetazolamide
Short-term Tolerability of Acetazolamide vs Diazepam	1 Participants	2 Participants

Adverse Events

Diazepam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acetazolamide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Katherine Nickels

Mayo Clinic

Phone: 5072660774

Email: nickels.katherine@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place