Verapamil as Therapy for Children and Young Adults With Dravet Syndrome
Completed · Phase 2
Conditions studied: Dravet Syndrome
In brief
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.
Key facts
- Study ID
- NCT01607073
- Run by
- Gillette Children's Specialty Healthcare
- People needed
- 2
- Starts
- 2012-04-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2021-04-13
Who can join
Age: 2 and older, up to 25. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Children's Memorial Hospital — Chicago, Illinois, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Gillette Children's Specialty Healthcare — Saint Paul, Minnesota, United States
- Mary Hitchcock Memorial Hospital — Lebanon, New Hampshire, United States
Full record on ClinicalTrials.gov
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