195. Noonan syndrome Clinical trials / Disease details


Clinical trials : 14 Drugs : 15 - (DrugBank : 5) / Drug target genes : 2 - Drug target pathways : 9

  
No.TrialIDDate_
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PhaseCountries
1NCT03435627
(ClinicalTrials.gov)
February 26, 201831/1/2018Post Marketing Surveillance on Long-term Use With Norditropin® (Short Stature Due to Noonan Syndrome)Post Marketing Surveillance on Long-term Use With Norditropin® (Short Stature Due to Noonan Syndrome)Genetic Disorder;Noonan SyndromeDrug: SomatropinNovo Nordisk A/SNULLCompleted3 YearsN/AAll71Japan
2EUCTR2016-005022-10-DE
(EUCTR)
13/02/201809/11/2017Improvement of synaptic plasticity and cognitive function in RAS pathway disordersImprovement of synaptic plasticity and cognitive function in RAS pathway disorders Noonan Syndrom and Neurofibromatosis Type 1
MedDRA version: 20.0;Level: PT;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10029268;Term: Neurofibromatosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lovastatin
INN or Proposed INN: Lovastatin
Other descriptive name: LOVASTATIN
Product Name: Lamotrigin beta
INN or Proposed INN: Lamotrigin
Technische Universität München, Fakultät für MedizinNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2Germany
3NCT02713945
(ClinicalTrials.gov)
January 25, 20179/3/2016Treatment With HMG-COA Reductase Inhibitor of Growth and Bone Abnormalities in Children With Noonan SyndromeTreatment With HMG-COA Reductase Inhibitor (Simvastatin) of Growth and Bone Abnormalities in Children With Noonan Syndrome: A Phase III Randomised, Double Blind, Placebo-controlled Therapeutic TrialNoonan SyndromeDrug: Simvastatin;Drug: PlaceboUniversity Hospital, ToulouseNULLRecruiting6 Years16 YearsAll62Phase 3France
4EUCTR2016-000647-14-FR
(EUCTR)
23/05/201630/03/2016Treatment with simvastatin of growth and bone abnormalities in children with Noonan syndromeTreatment with HMG-COA reductase inhibitor (simvastatin) of growth and bone abnormalities in children with Noonan syndrome : a phase III randomised, double-blind, placebo-controlled therapeutic trial - RASTAT Noonan syndrome;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]Trade Name: Simvastatin
Product Name: Simvastatin
University Hospital ToulouseNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
62Phase 3France
5NCT02383316
(ClinicalTrials.gov)
January 201523/12/2014Study of Metabolic Modifications in Children With Noonan SyndromeStudy of Metabolic Modifications in Children With Noonan SyndromeChild SyndromeOther: Oral Glucose tolerance testUniversity Hospital, ToulouseNULLCompleted7 Years18 YearsAll20N/AFrance
6NCT01927861
(ClinicalTrials.gov)
August 19, 201320/8/2013Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan SyndromeA 52-week, Multi-centre, Randomised, Double-blind, Parallel-group, no Treatment Controlled (Open-label) Trial Investigating the Efficacy and Safety of Two Doses of NN-220 in Short Stature With Noonan SyndromeGenetic Disorder;Noonan SyndromeDrug: somatropinNovo Nordisk A/SNULLCompleted3 Years10 YearsAll51Phase 3Japan
7NCT01556568
(ClinicalTrials.gov)
February 201215/3/2012Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic CardiomyopathyAn Open Label Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic CardiomyopathyCardiomegalyDrug: MEK162Array Biopharma, now a wholly owned subsidiary of PfizerNULLWithdrawn18 Years65 YearsAll0Phase 2United States;United Kingdom
8EUCTR2011-003392-10-GB
(EUCTR)
23/01/201224/08/2011A study to look at the effect of the study drug on heart muscle thickness, the amount of drug that ends up in the blood, and the safety and tolerability of study drug in Noonan syndrome patients.An open label study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEK162 in Noonan syndrome hypertrophic cardiomyopathy. Noonan syndrome hypertrophic cardiomyopathy
MedDRA version: 14.1;Level: PT;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: MEK162Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
22United Kingdom;United States
9NCT01529944
(ClinicalTrials.gov)
September 20082/1/2012Genetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658Genetic Testing of Noonan Subjects Previously Treated With Norditropin® in the GHNOO-1658 TrialGenetic Disorder;Noonan SyndromeDrug: somatropinNovo Nordisk A/SNULLCompletedN/AN/ABoth22Phase 3Sweden
10NCT00351221
(ClinicalTrials.gov)
May 200611/7/2006Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan SyndromeA Phase 2, Open-Label, Multicenter, Clinical Trial to Evaluate the Pharmacokinetics, Safety and Efficacy of Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 in Children With Growth Failure Due to Noonan SyndromeNoonan SyndromeDrug: rhIGF-1/rhIGFBP-3Insmed IncorporatedNULLTerminated2 Years16 YearsBoth24Phase 2United States
11NCT00960128
(ClinicalTrials.gov)
April 1, 200613/8/2009Observational Prospective Study on Patients Treated With Norditropin®NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin®Growth Hormone Disorder;Growth Hormone Deficiency in Children;Adult Growth Hormone Deficiency;Genetic Disorder;Turner Syndrome;Foetal Growth Problem;Small for Gestational Age;Chronic Kidney Disease;Chronic Renal Insufficiency;Noonan SyndromeDrug: somatropinNovo Nordisk A/SNULLCompletedN/AN/AAll21249N/AArgentina;Belgium;Czechia;Denmark;Finland;France;Germany;Hungary;Ireland;Israel;Italy;Lithuania;Luxembourg;Netherlands;Norway;Russian Federation;Saudi Arabia;Serbia;Slovenia;Spain;Sweden;Switzerland;United Kingdom;Brazil;Czech Republic;Former Serbia and Montenegro
12EUCTR2005-000042-37-SE
(EUCTR)
11/07/200512/04/2005Norditropin Treatment in Subjects with Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up VisitNorditropin Treatment in Subjects with Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up Visit Noonan syndrome associated short stature
MedDRA version: 7.1;Level: PT;Classification code 10029748
Trade Name: Norditropin 24 IU
Product Name: Norditropin 24 IU
INN or Proposed INN: Somatropin
Trade Name: Norditropin SimpleXx
Product Name: Norditropin SimpleXx
INN or Proposed INN: Somatropin
INN or Proposed INN: Somatropin
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
Sweden
13NCT00452725
(ClinicalTrials.gov)
October 199723/3/2007Effect of MAXOMAT ® on the Growth of Small Children to NOONAN's SyndromeEffect of the Growth Hormone MAXOMAT ® on the Growth of Small Children and Adolescents (<-2 SD) Due to NOONAN's SyndromeNoonan SyndromeDrug: MAXOMAT ®, biosynthetic growth hormoneSanofiNULLCompleted3 Years15 YearsBoth36Phase 3France
14NCT01529840
(ClinicalTrials.gov)
June 19902/1/2012Somatropin Effect on Linear Growth and Final Height in Subjects With Noonan SyndromeNorditropin Treatment in Subjects With Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up VisitGenetic Disorder;Noonan SyndromeDrug: somatropinNovo Nordisk A/SNULLCompleted18 YearsN/AAll24Phase 3Sweden