Down Syndrome
Conditions
Sponsors
Eisai Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) With definitive diagnosis of Down syndrome (2) Have greater than or equal to 3 of the following 4 symptoms; Survey on Sudden Regression, Motor retardation, mutism, social withdrawal, sleep disorder (3) Must have a family member or a caregiver who will be able to support the subject during the study by providing necessary study information to the subject, assisting treatment compliance, and accompanying the subject to all scheduled visits, supporting study-related tests for the efficacy and safety assessments throughout the study period
Exclusion criteria
Exclusion criteria: 1.Suspected to have progressive neuropsychiatric disease (e.g., neurodegenerative disorder and progressive tumor) evidenced by MRI or CT within 1 year before the Pre-randomization Phase (if not tested within 1 year before the Pre-randomization Phase, reconfirm during the Pre-randomization Phase). 2.Have a history of significant neurological disorders such as stroke, brain tumor, encephalitis, meningitis, normal pressure hydrocephalus, brain trauma accompanying unconsciousness, and experience of brain surgery causing unsolved deficiency 3.Previously diagnosed with autism 4.With evidence of atlantoaxial subluxation, or underwent surgical operation for atlantoaxial subluxation within 2 years 5.Have seizure symptoms within 2 years or used antiepileptic drug within 1 year before enrollment of Pre-randomization Phase. 6.With severe hearing or visual impairment which may affect regression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the changes in total scores from baseline using Body Functionality Checklist relative to placebo. the changes in total scores from baseline using Body Functionality Checklist relative to placebo. | — |
Outcome results
None listed