Sex Chromosome Disorders News - LARVOL Sigma

Sex Chromosome Disorders

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|||||||||| Trial completion: Defining the Optimal Hormonal Replacement Therapy in Turner Syndrome (clinicaltrials.gov) - Jun 12, 2013
P4, N=43, Completed, Sponsor: Line Cleemann
Active, not recruiting --> Completed

||||||||||  Norditropin (somatropin) / Novo Nordisk
Trial termination:  Initiating Transdermal Estradiol Therapy in Turner's Syndrome (clinicaltrials.gov) -  Jun 5, 2013
P1, N=1, Terminated,  Sponsor: University of Chicago
Active, not recruiting --> Completed Recruiting --> Terminated; Poor accrual

||||||||||  Norditropin (somatropin) / Novo Nordisk
Enrollment change:  Initiating Transdermal Estradiol Therapy in Turner's Syndrome (clinicaltrials.gov) -  Jun 5, 2013
P1, N=1, Terminated,  Sponsor: University of Chicago
Recruiting --> Terminated; Poor accrual N=60 --> 1

|||||||||| Trial termination: The Natural History of Reproductive and Overall Health in Girls and Women With a Pre-Mutation in the FMR1 Gene; Creation of a Patient Registry (clinicaltrials.gov) - May 31, 2013
P=N/A, N=7, Terminated, Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
N=60 --> 1 Recruiting --> Terminated

|||||||||| Enrollment change: The Natural History of Reproductive and Overall Health in Girls and Women With a Pre-Mutation in the FMR1 Gene; Creation of a Patient Registry (clinicaltrials.gov) - May 31, 2013
P=N/A, N=7, Terminated, Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Recruiting --> Terminated N=1000 --> 7

|||||||||| Trial initiation date: EXPLAIN -FragilE X Registry: An exPlorative Longitudinal Study for chAracterIzation, Treatment Pathways and patieNt-related Outcomes (clinicaltrials.gov) - May 9, 2013
P=N/A, N=300, Recruiting, Sponsor: Novartis Pharmaceuticals
N=1000 --> 7 Initiation date: Oct 2012 --> Apr 2013

|||||||||| Enrollment open: EXPLAIN -FragilE X Registry: An exPlorative Longitudinal Study for chAracterIzation, Treatment Pathways and patieNt-related Outcomes (clinicaltrials.gov) - May 9, 2013
P=N/A, N=300, Recruiting, Sponsor: Novartis Pharmaceuticals
Initiation date: Oct 2012 --> Apr 2013 Not yet recruiting --> Recruiting

||||||||||  Nebido (testosterone undecanoate depot injection) / Bayer
Enrollment open:  ALCeP: Androgen for Leydig Cell Proliferation (clinicaltrials.gov) -  May 4, 2013
P2/3, N=20, Recruiting,  Sponsor: University of Roma La Sapienza
Not yet recruiting --> Recruiting Active, not recruiting --> Recruiting

|||||||||| Enrollment change: Turner Syndrome: Genotype and Phenotype (clinicaltrials.gov) - Apr 24, 2013
P=N/A, N=1017, Active, not recruiting, Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Active, not recruiting --> Recruiting N=1300 --> 1017

|||||||||| Enrollment closed: Turner Syndrome: Genotype and Phenotype (clinicaltrials.gov) - Apr 24, 2013
P=N/A, N=1017, Active, not recruiting, Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
N=1300 --> 1017 Recruiting --> Active, not recruiting

||||||||||  sertraline / Generic mfg.
Enrollment change:  Trial of Sertraline to Treat Children With Fragile X Syndrome (clinicaltrials.gov) -  Apr 4, 2013
P=N/A, N=72, Recruiting,  Sponsor: University of California, Davis
Recruiting --> Active, not recruiting N=60 --> 72

|||||||||| Enrollment closed: Sex Differences in Early Brain Development; Brain Development in Turner Syndrome (clinicaltrials.gov) - Mar 31, 2013
P=N/A, N=320, Active, not recruiting, Sponsor: University of North Carolina, Chapel Hill
N=60 --> 72 Recruiting --> Active, not recruiting

||||||||||  Growtropin-II (somatropin biosimilar) - Dong / A
New P3 trial:  A Clinical Study to Assess the Efficacy and Safety of DA-3002 (clinicaltrials.gov) -  Mar 17, 2013
P3, N=58, Recruiting,  Sponsor: Dong-A Pharmaceutical Co., Ltd.

|||||||||| Enrollment open: Aortopathy in Persons With Bicuspid Aortic Valve, Turner and Marfan Syndrome (clinicaltrials.gov) - Mar 17, 2013
P=N/A, N=60, Recruiting, Sponsor: University of Aarhus
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting

|||||||||| Enrollment open: X-chromosome Inactivation, Epigenetics and the Transcriptome (clinicaltrials.gov) - Mar 17, 2013
P=N/A, N=395, Recruiting, Sponsor: University of Aarhus
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial termination:  An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome (clinicaltrials.gov) -  Dec 18, 2012
P2, N=45, Terminated,  Sponsor: Seaside Therapeutics, Inc.
Not yet recruiting --> Recruiting Enrolling by invitation --> Terminated; all active subjects rolled into 209FX303/NCT01013480

||||||||||  STX107 / Seaside Therapeutics
Trial suspension:  A Study to Assess the Tolerability of a Single Dose of STX107 in Adults With Fragile X Syndrome (clinicaltrials.gov) -  Dec 18, 2012
P2, N=16, Suspended,  Sponsor: Seaside Therapeutics, Inc.
Enrolling by invitation --> Terminated; all active subjects rolled into 209FX303/NCT01013480 Not yet recruiting --> Suspended

||||||||||  arbaclofen (STX209) / Allos Pharma
Enrollment change:  An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome (clinicaltrials.gov) -  Dec 18, 2012
P2, N=45, Terminated,  Sponsor: Seaside Therapeutics, Inc.
Not yet recruiting --> Suspended N=60 --> 45

||||||||||  basimglurant (NOE-101) / Noema Pharma
New P2 trial:  A Study of RO4917523 in Pediatric Patients With Fragile X Syndrome (clinicaltrials.gov) -  Dec 13, 2012
P2, N=47, Active, not recruiting,  Sponsor: Hoffmann-La Roche

||||||||||  Norditropin (somatropin) / Novo Nordisk
Biomarker, New P4 trial:  Growth Response in Girls With Turner Syndrome (clinicaltrials.gov) -  Nov 25, 2012
P4, N=31, Completed,  Sponsor: Novo Nordisk

||||||||||  Nutropin AQ (somatropin) / Ipsen, Roche
Trial completion:  A Study to Evaluate Subjects With Turner Syndrome Treated With Growth Hormone (clinicaltrials.gov) -  Nov 12, 2012
P4, N=1696, Completed,  Sponsor: Genentech
N=60 --> 45 Active, not recruiting --> Completed

||||||||||  Nutropin AQ (somatropin) / Ipsen, Roche
Trial completion:  Bone Mineral Density (BMD) in Adolescents With Growth Hormone Deficiency (GHD) (clinicaltrials.gov) -  Nov 12, 2012
P4, N=125, Completed,  Sponsor: Genentech
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| New P3 trial: Induction of Puberty With 17-beta Estradiol in Girls With Turner Syndrome (clinicaltrials.gov) - Oct 17, 2012
P3, N=50, Completed, Sponsor: Novo Nordisk

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial completion:  Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X Syndrome (clinicaltrials.gov) -  Sep 27, 2012
P2, N=63, Completed,  Sponsor: Seaside Therapeutics, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Clinical: Life Quality and Health in Patients With Klinefelter Syndrome (clinicaltrials.gov) - Sep 19, 2012
P=N/A, N=1350, Enrolling by invitation, Sponsor: University of Aarhus

|||||||||| Enrollment closed: Neuropsychologic, Neuroradiologic, Endocrinologic, and Genetic Aspects of Klinefelter Syndrome (clinicaltrials.gov) - Sep 5, 2012
P=N/A, N=450, Active, not recruiting, Sponsor: University of Aarhus
Active, not recruiting --> Completed Recruiting --> Active, not recruiting

|||||||||| Trial completion: The Effect of Androgen and Growth Hormone on Height and Learning in Girls With Turner Syndrome (clinicaltrials.gov) - Jun 3, 2012
P3, N=200, Completed, Sponsor: Thomas Jefferson University
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

||||||||||  Norditropin (somatropin) / Novo Nordisk
Clinical:  Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome (clinicaltrials.gov) -  May 21, 2012
P=N/A, N=2000, Enrolling by invitation,  Sponsor: Novo Nordisk

||||||||||  basimglurant (NOE-101) / Noema Pharma
Trial initiation date:  A Study of RO4917523 in Patients With Fragile X Syndrome (clinicaltrials.gov) -  May 20, 2012
P2, N=185, Active, not recruiting,  Sponsor: Hoffmann-La Roche
Active, not recruiting --> Completed Initiation date: Jan 2012 --> May 2012

||||||||||  Norditropin (somatropin) / Novo Nordisk
Trial completion:  Usability and Tolerability of the Norditropin NordiFlex (clinicaltrials.gov) -  Apr 17, 2012
P=N/A, N=79, Completed,  Sponsor: Novo Nordisk
Initiation date: Jan 2012 --> May 2012 Active, not recruiting --> Completed

||||||||||  Zorbtive (somatropin) / EMD Serono
Enrollment change, Compliance:  Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector (clinicaltrials.gov) -  Mar 28, 2012
P=N/A, N=834, Completed,  Sponsor: Merck KGaA
Active, not recruiting --> Completed N=630 --> 834

||||||||||  minocycline / Generic mfg.
Trial completion:  Trial of Minocycline to Treat Children With Fragile X Syndrome (clinicaltrials.gov) -  Mar 27, 2012
P=N/A, N=66, Completed,  Sponsor: University of California, Davis
N=630 --> 834 Recruiting --> Completed

||||||||||  Norditropin (somatropin) / Novo Nordisk
New P3 trial:  Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency (clinicaltrials.gov) -  Mar 25, 2012
P3, N=168, Completed,  Sponsor: Novo Nordisk

||||||||||  arbaclofen (STX209) / Allos Pharma
New P3 trial:  An Open Label Extension Study in Subjects With Fragile X Syndrome (clinicaltrials.gov) -  Mar 13, 2012
P3, N=357, Terminated,  Sponsor: Seaside Therapeutics, Inc.

||||||||||  equine conjugated estrogens / Generic mfg.
Trial completion:  A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions. (clinicaltrials.gov) -  Mar 13, 2012
P1, N=72, Completed,  Sponsor: Pfizer
Recruiting --> Completed Recruiting --> Completed

||||||||||  Zomacton (somatropin) / Ferring
Trial completion, Compliance:  Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device (clinicaltrials.gov) -  Feb 5, 2012
P=N/A, N=87, Completed,  Sponsor: Ferring Pharmaceuticals
Recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Norditropin (somatropin) / Novo Nordisk
New P3 trial:  Use of Somatropin in Turner Syndrome (clinicaltrials.gov) -  Jan 23, 2012
P3, N=57, Completed,  Sponsor: Novo Nordisk

||||||||||  basimglurant (NOE-101) / Noema Pharma
New P2 trial:  A Study of RO4917523 in Patients With Fragile X Syndrome (clinicaltrials.gov) -  Jan 23, 2012
P2, N=185, Active, not recruiting,  Sponsor: Hoffmann-La Roche

||||||||||  Norditropin (somatropin) / Novo Nordisk
New P4 trial:  Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome (clinicaltrials.gov) -  Jan 23, 2012
P4, N=65, Completed,  Sponsor: Novo Nordisk

||||||||||  sertraline / Generic mfg.
Enrollment open:  Trial of Sertraline to Treat Children With Fragile X Syndrome (clinicaltrials.gov) -  Jan 4, 2012
P=N/A, N=72, Recruiting,  Sponsor: University of California, Davis
Active, not recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Enrollment change: Beta Cell Function in Women With Turner Syndrome (clinicaltrials.gov) - Nov 6, 2011
P=N/A, N=25, Terminated, Sponsor: University of Aarhus
Not yet recruiting --> Recruiting N=12 --> 25

|||||||||| Trial completion: Growth Hormone Treatment of Women With Turner Syndrome (clinicaltrials.gov) - Nov 6, 2011
P=N/A, N=24, Completed, Sponsor: Britta E. Hjerrild
N=12 --> 25 Recruiting --> Completed

||||||||||  basimglurant (NOE-101) / Noema Pharma
Enrollment change:  A Study With RO4917523 in Patients With Fragile X Syndrome (clinicaltrials.gov) -  Oct 13, 2011
P2, N=40, Completed,  Sponsor: Hoffmann-La Roche
Recruiting --> Completed N=32 --> 40

||||||||||  basimglurant (NOE-101) / Noema Pharma
Trial completion:  A Study With RO4917523 in Patients With Fragile X Syndrome (clinicaltrials.gov) -  Oct 13, 2011
P2, N=40, Completed,  Sponsor: Hoffmann-La Roche
N=32 --> 40 Active, not recruiting --> Completed

||||||||||  equine conjugated estrogens / Generic mfg.
New P1 trial:  A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions. (clinicaltrials.gov) -  Sep 15, 2011
P1, N=72, Completed,  Sponsor: Pfizer

||||||||||  mavoglurant (AFQ056) / Novartis
New P2/3 trial:  Long-term, Safety and Tolerability Study of AFQ056 in Adolescent Patients With Fragile X Syndrome (Open-label) (clinicaltrials.gov) -  Sep 11, 2011
P2/3, N=170, Recruiting,  Sponsor: Novartis Pharmaceuticals

||||||||||  Norditropin (somatropin) / Novo Nordisk
Enrollment change:  Observational Prospective Study on Patients Treated With Norditropin® (clinicaltrials.gov) -  Aug 23, 2011
P=N/A, N=17000, Enrolling by invitation,  Sponsor: Novo Nordisk
Active, not recruiting --> Completed N=10000 --> 17000

|||||||||| Biomarker, New P4 trial: EMR 200104_010: First Year Growth Response Associated Genetic Markers Validation Phase IV Open-label Study in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children: the PREDICT Pharmacogenetics Validation Study (clinicaltrials.gov) - Aug 16, 2011
P4, N=458, Completed, Sponsor: Merck KGaA

||||||||||  Zorbtive (somatropin) / EMD Serono
Trial completion:  Growth Hormone Treatment for the Prevention of Short Stature in Young Girls With Turner Syndrome Before the Age of 4 Years (clinicaltrials.gov) -  Aug 11, 2011
P4, N=64, Completed,  Sponsor: Merck KGaA
N=10000 --> 17000 Active, not recruiting --> Completed