An open-label study of two single oral doses of galantamine, examining the pharmacokinetics, safety, and tolerability in children with Down syndrome - N.A.

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003359-19-NL

Enrollment

Registered

2006-12-22

Start date

2007-08-07

Completion date

Unknown

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children with Down syndrom MedDRA version: 8.1 Level: LLT Classification code 10013616 Term: Down's syndrome

Interventions

Trade Name: Reminyl 4 mg/ml, drank Pharmaceutical Form: Oral solution INN or Proposed INN: galantamine hydrobromide CAS Number: 1953-04-04 Current Sponsor code: N.A. Other descriptive name: N.A. Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children with Down syndrome, genetically cariotyped with trysomy 21, meiotic non-disjunction Subjects aged between 9 - 16 years Subjects naive to any cholinerg drug Subjects of childbearing potential must have a negative serum beta-hcg pregnancy test and must use a reliable contraceptive Subjects should have sufficiently developed language and memory skills to perform neurocognitive tests 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the pharmacokinetic characteristics of glantamine 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	—

Countries

Belgium, Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026