Effect of MAXOMAT ® on the Growth of Small Children to NOONAN's Syndrome
Phase 3
Completed
- Conditions
- Noonan Syndrome
- Registration Number
- NCT00452725
- Lead Sponsor
- Sanofi
- Brief Summary
1. Clinical Objective : To improve the growth of these children
2. Genetic objective : A study of the genetics of the syndrome
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Children and adolescents with Noonan's syndrome with a height < -2 SD and no progressive cardiopathy
Exclusion Criteria
- Age < 3 years
- Height ≥ -2 SD
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Evaluation of height : gain in height and rate of growth at each visit (every 3 months) or every 6 months
- Secondary Outcome Measures
Name Time Method Clinical and laboratory test safety every 6 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie growth hormone efficacy in Noonan Syndrome patients with PTPN11 mutations?
How does MAXOMAT compare to standard growth hormone therapies for short stature in Noonan Syndrome (NCT00452725)?
Which biomarkers correlate with height velocity response to somatropin in NCT00452725 Noonan Syndrome cohort?
What adverse events were reported in Sanofi's Phase 3 MAXOMAT trial for Noonan Syndrome (<-2 SD growth)?
Are there combination therapies or alternative drugs targeting RAS/MAPK pathway for Noonan Syndrome growth impairment?
Trial Locations
- Locations (1)
Sanofi-Aventis
🇫🇷Paris, France