CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 2 enrolled
Drug / intervention
Verapamildrug
Likely dose
Verapamil 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01607073
NCT01607073Phase 2Completed

Verapamil as Adjunctive Seizure Therapy for Children and Young Adults With Dravet Syndrome

Gillette Children's Specialty Healthcare·interventional·Posted May 28, 2012·Updated Apr 13, 2021

In Brief

A Phase 2 clinical trial evaluating Verapamil for Dravet Syndrome. Completed, enrolled 2 participants across 4 sites.

Detailed Summary

This study will assess how well the drug verapamil can improve control of seizures and dysautonomia symptoms in children and young adults diagnosed with Dravet syndrome. The safety of verapamil when given with all concomitant medications will also be assessed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDravet Syndrome
CountriesUnited States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 28, 2012
Enrollment StartApr 1, 2012
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.1 years ago

Interventions

Verapamildrug

Verapamil will be prepared as a solution. A 50mg/ml oral suspension may be made with immediate release tablets and either a 1:1 mixture of Ora-Sweet and Ora-Plus or a 1:1 mixture of Ora-Sweet SF and Ora-Plus will be used. Children will start on a 4 weeks titration period: Week 1: 1mg/kg/day divided BID Week 2: 2mg/kg/day divided BID or TID Week 3: 3mg/kg/day divided BID or TID Week 4: 4mg/kg/day divided TID In event of adverse events, and in consultation with the family and treating physician, the dosage may be decreased to 2mg/kg/day and remain at that dose for the remainder of the study.