An open-label study of two single oral doses of galantamine, examining the pharmacokinetics, safety, and tolerability in children with Down syndrome - N.A.
- Conditions
- Children with Down syndromeMedDRA version: 8.1Level: LLTClassification code 10013616Term: Down's syndrome
- Registration Number
- EUCTR2006-003359-19-BE
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 16
Children with Down syndrome, genetically cariotyped with trysomy 21, meiotic non-disjunction
Subjects aged between 9 - 16 years (inclusive)
Subjects naive to any cholinergic drug
Subjects of childbearing potential must have a negative serum beta-hcg pregnancy test and must use a reliable contraceptive
Subjects and/or parents should have provided informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the pharmacokinetic characteristics of galantamine after 2 single oral doses in children with Down syndrome.;Secondary Objective: Secondary objectives are to evaluate safety and tolerability.;Primary end point(s): Pharmacokinetic evaluation will be performed and safety will be evaluated
- Secondary Outcome Measures
Name Time Method