An open-label study of two single oral doses of galantamine, examining the pharmacokinetics, safety, and tolerability in children with Down syndrome
- Conditions
- Down syndromemeiotic non-disjunctiontrisomy 2110083624
- Registration Number
- NL-OMON30535
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 16
Children with Down syndrome, genetically cariotyped with trysomy 21, meiotic non-disjunction, aged between 9 - 16 years, naive to any cholinerg drug, if subject is of childbearing potential she must have a negative serum beta-hcg pregnancy test and must use a reliable contraceptives, and subjects (if > 11 years of age) and parents should have provided informed consent
Known hypersensitivity to galantamine hydrobromide or any excipients used in the formulation, history of severe drug allergy or hypersensitivity, weight/height below the 5th percentile for age on the standardized curve for subjects with Down syndrome Trisomy 21, mosaic (mitotic non-disjunction) Trisomy 21, translocation, subject having received prohibited medication, history or presence of one of the specified conditions possibly resulting in cognitive impairment, current clinically significant cardiovascular disease, gastrointestinal disease, psychiatric disease, uncorrected hearing or visual disturbances, hepatic, renal or pulmonary disturbances, urinary outflow obstructions, history of epilepsy, malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Plasma concentrations of galantamine will be determined from samples taken at<br /><br>baseline, then after 0.5h, 1h, 2h, 4h, 8h, 24h, and 28h following dosing on the<br /><br>2 profile days.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety will be evaluated on the basis of adverse event reports, laboratory<br /><br>values and ECG findings.</p><br>