Verapamil as Therapy for Children and Young Adults With Dravet Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 12 April 2021
• Main ID: NCT01607073
• Date of registration: 24/05/2012
• Prospective Registration: No
• Primary sponsor: Gillette Children's Specialty Healthcare
• Public title: Verapamil as Therapy for Children and Young Adults With Dravet Syndrome
• Scientific title: Verapamil as Adjunctive Seizure Therapy for Children and Young Adults With Dravet Syndrome
• Date of first enrolment: April 2012
• Target sample size: 2
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01607073
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Beverly S Wical, MD
• Affiliation: Gillette Children's Specialty Healthcare

Key inclusion & exclusion 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



Age minimum: 2 Years
Age maximum: 25 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dravet Syndrome

Intervention(s)

Drug: Verapamil

Primary Outcome(s)

Change in Number of General Tonic-clonic Seizures From Week 8 (Baseline) Visit to Week 12 Visit [Time Frame: Week 8 (baseline) to Week 12]

Secondary Outcome(s)

Change in Number of Absence Seizures From Week 8 (Baseline) to Week 12 [Time Frame: Week 8 to Week 12]

Change in Number of Myoclonic Seizures From Week 8 (Baseline) to Week 12 [Time Frame: Week 8 (baseline) to Week 12]

Secondary ID(s)

IND 113666

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mayo Clinic

Ann & Robert H Lurie Children's Hospital of Chicago

Dartmouth-Hitchcock Medical Center

Results

• Results available: Yes
• Date Posted: 23/03/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01607073