This study will evaluate the status of the growth hormone/ insulin-like growth factor-1 (GH/IGF-1) axis in relation to growth failure, body weight and composition and neuroprotection in children with Ataxia telangiectasia (AT)
Conditions
Interventions
Trade Name: Catapresan 75, Tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Clonidinhydrochlorid
CAS Number: 4205-91-8
Concentration unit: µg microgram(s)
Concentration type: equal
Concentra
Sponsors
Goethe-Universität Frankfurt/Main
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • diagnosis of AT • no fusion of epiphyses/closed growth plates determined by X-ray of left wrist and hand (special skeletal age film) • age between 3 years to 18 years and no completed puberty • growth failure: height below the 10th percentile for chronological age • growth failure, defined as growth velocity (measured as linear growth) less than 5% to 10% of that expected for children of the same age group, over the past 12 months •provide evidence of serum IGF-1 level performed within the preceding 6 months and the results fall below normal limits for age 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: • fusion of epiphyseal plates • age under 3 years or completion of puberty • serum IGF-1 level that is within normal limits for age • be above the 10th percentile height for chronological age • history of anaphylactic reaction or hypersensitivity to one of the GH formulation • any active or suspected neoplasia • signs of intracranial hypertension as evidenced by papilledema
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: Primary efficacy endpoint: The primary objective is to evaluate the IGF1/GH increase after Arginine provocation test ;Secondary Objective: Secondary objective(s): The GH increase after Clonidine Provocation Test To evaluate the safety and efficacy of the IgF-1 generation test. To correlate GH/IGF-1 deficiency to BMI To correlate GH/IGF-1 deficiency to MRI findings ;Primary end point(s): Primary efficacy endpoint: The primary objective is to evaluate the IGF1/GH increase after Arginine provocation test | — |
Countries
Germany
Outcome results
None listed