Phase 2
N=2
Verapamil as Therapy for Children and Young Adults With Dravet Syndrome
Dravet Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01607073 ↗Enrolled (actual)
2
Serious AEs
50.0%
Results posted
Mar 2021
Primary outcome: Primary: Change in Number of General Tonic-clonic Seizures From Week 8 (Baseline) Visit to Week 12 Visit — 39; 14 General tonic-clonic seizures
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Verapamil (Drug)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Gillette Children's Specialty Healthcare
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Number of General Tonic-clonic Seizures From Week 8 (Baseline) Visit to Week 12 Visit |
39; 14 | — |
| SECONDARY Change in Number of Myoclonic Seizures From Week 8 (Baseline) to Week 12 |
116; 175 | — |
| SECONDARY Change in Number of Absence Seizures From Week 8 (Baseline) to Week 12 |
165; 101 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 2 to 25 years old
- Onset of seizures in first year of life
- seizure type usually generalized tonic-clonic, clonic, or hemiclonic, often prolonged (>10 minutes)
- myoclonic jerks/myoclonic seizures
- history of normal development at seizure onset with subsequent developmental delay or regression which occurs after seizure onset
- presence of documented abnormality on the SCN1A gene
- medically intractable epilepsy: must have been on at least 2 prior antiepileptic medications without adequate control of epilepsy
- subject is capable of giving informed consent (or assent if possible) or has an acceptable surrogate capable of giving informed consent on the subject's behalf
Exclusion Criteria
- use of clonidine, propranolol, carbamazepine, oxcarbazine, stiripentol, lamotrigine, or cyclosporine
- Abnormalities of cardiac conduction or rhythm (excluding sinus arrhythmia) on screening EKG
- significant use of grapefruit juice
- ketogenic diet
- pregnancy
Data sourced from ClinicalTrials.gov (NCT01607073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.