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

• Register: EUCTR
• Last refreshed on: 9 January 2017
• Main ID: EUCTR2006-003359-19-NL
• Date of registration: 22/12/2006
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V.
• Public title: An open-label study of two single oral doses of galantamine, examining the pharmacokinetics, safety, and tolerability in children with Down syndrome - N.A.
• Scientific title: An open-label study of two single oral doses of galantamine, examining the pharmacokinetics, safety, and tolerability in children with Down syndrome - N.A.
• Date of first enrolment: 07/08/2007
• Target sample size: 16
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003359-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Netherlands

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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.
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 4-

Primary Outcome(s)

Main Objective: To determine the pharmacokinetic characteristics of glantamine after 2 single oral doses in children with Down syndrome.

Primary end point(s): Pharmacokinetic evaluation will be performed and safety will be evaluated

Secondary Objective: Secondary objectives are to evaluate safety and tolerability.

Secondary ID(s)

N.A.

GALPED1001