About DIACOMIT
DIACOMIT® (stiripentol) is an FDA-approved antiseizure medication developed specifically for seizures associated with Dravet syndrome in children as young as 6 months (weighing 15 pounds or more) and taking clobazam. There are no clinical data to support the use of DIACOMIT as a monotherapy for Dravet syndrome.1
What is DIACOMIT (stiripentol)?
DIACOMIT was developed as an add-on therapy to clobazam for when seizures are not adequately controlled. In 2000, it was approved for compassionate use in the United States, and in 2018, it was granted FDA approval.9,10,15
Many healthcare professionals may recognize DIACOMIT by its generic name, stiripentol. That’s because this treatment was referred to by its generic name for 18 years under the compassionate use program, until the FDA granted approval in 2018.1,5
DIACOMIT is the only treatment specifically for seizures associated with Dravet syndrome in children as young as 6 months.1
DIACOMIT has clinically demonstrated efficacy in managing Dravet seizures and is proven to control prolonged seizures.1,2,16
Substantial Seizure Relief Backed by Results
In two randomized, placebo-controlled clinical trials, patients with Dravet syndrome on DIACOMIT experienced significantly fewer clonic or tonic-clonic seizures than those on placebo. 1,2
In clinical studies, DIACOMIT reduced seizures by 84%*, with 39% of patients becoming seizure-free after two months of treatment.1,6
*Median seizure frequency
Clinical Trials Descriptions
DIACOMIT (stiripentol) was tested in two clinical trials, STICLO France and STICLO Italy. In both studies, patients were randomly split into two groups: one group on stiripentol (with clobazam and valproate) and one group on placebo (with clobazam and valproate).1,5
Together, the studies included 56 patients with Dravet syndrome from 3 to 18 years old with inadequately controlled seizures. Researchers measured the response to treatment, or how many patients experienced a 50% or greater reduction in seizures.6,7 Including both studies, 74% of patients experienced a 50% or more reduction in generalized clonic or tonic-clonic seizures compared with baseline and 39% patients became completely seizure-free for at least eight weeks.1,5,6
Safety in the Clinical Trials
During the studies, the most common side effects, occurring in 10% or more of patients on DIACOMIT and more frequently than placebo, were:1
- Sleepiness (67%)
- Decreased appetite (45%)
- Agitation (27%)
- Impaired coordination (27%)
- Decreased weight (27%)
- Decreased muscle tone (24%)
- Nausea (15%)
- Tremor (15%)
- Slurred speech (12%)
- Insomnia (12%)
Across five other studies, side effects in children with Dravet syndrome who were 6 months to less than 2 years of age were similar to those seen in the pivotal studies. The side effects of DIACOMIT are manageable. To learn more about managing side effects, talk to your child’s doctor about dose adjustments to co-medications. Visit Starting DIACOMIT to read more.
Complete the DIACOMIT Discussion Guide
Review talking points to help you start the conversation about DIACOMIT with your child’s doctor.
Ready to make the DIACOMITment?
Understand the convenient dosing options.
Have more questions about Dravet syndrome?
Learn more about the signs and symptoms of Dravet seizures.