Âé¶¹´«Ã½Ó³»­

Âé¶¹´«Ã½Ó³»­

Explore the latest content from across our publications

Log In

Forgot Password?
Create New Account

Loading... please wait

Abstract Details

Concomitant Medication in Adolescent and Adult Individuals with Angelman Syndrome: Baseline Results from the Phase 2 STARS Study
Child Neurology and Developmental Neurology
P14 - Poster Session 14 (8:00 AM-9:00 AM)
5-001
To describe the use of concomitant medications at baseline among individuals with Angelman Syndrome (AS) participating in the STARS study.

AS is a rare, genetic, neurodevelopmental condition characterized by severe impairments in speech, behavior, motor skills, and sleep. There are currently no treatments that address the underlying pathophysiology. Only a few studies have described concomitant medications among individuals with AS.

The Phase 2 STARS study was a randomized, double-blind, placebo-controlled trial of OV101 (gaboxadol) in adolescents and adults with AS. Key inclusion criteria included molecular confirmation of AS and stable dose of concomitant medications for >4 weeks prior to baseline.

Eighty-seven participants were included in the safety set analysis (mean age, 22.6 ± 6.9 years). At Baseline almost all participants had a medical or surgical history (99%), of which the most common were: seizures (93%), constipation (56%), sleep disorder (44%), gastroesophageal reflux disease (28%), scoliosis (26%), anxiety (25%), tremor (18%), strabismus (17%), and seasonal allergy (17%). The majority of participants reported the use of concomitant medications (98%), of which the most common were: benzodiazepine derivatives (66%), including clonazepam (34%), diazepam (17%), lorazepam (13%), and clobazam (12%), used in the treatment of seizures. This was followed by other anti-epileptics (45%), including lamotrigine (20%), levetiracitam (18%), topiramate (18%), brivaracetam (13%) and valproic acid (10%). Other common prescription and over the counter medications included: melatonin (31%), polyethylene glycol (26%), ibuprofen (21%), vitamin supplements (17%), paracetamol (15%), omeprazole (15%), clonidine (14%), trazodone (10%), and ondansetron (10%).

AS is a life-long condition with heterogeneous clinical manifestations. Healthcare burden of participants in the STARS study was high with nearly all participants reporting surgeries, comorbidities and medication use.  These results are consistent with recently published observational studies in individuals with AS that used the data from the AS Natural History Study (NHS).
Authors/Disclosures

PRESENTER
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file