Autism Spectrum Disorder News - LARVOL Sigma

Autism Spectrum Disorder

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||||||||||  sodium valproate / Generic mfg.
New P2 trial:  Treatment of Children With Autism Spectrum Disorders and Epileptiform EEG With Divalproex Sodium (clinicaltrials.gov) -  Mar 20, 2014
P2, N=30, Not yet recruiting,  Sponsor: Children's Hospital Boston

|||||||||| Enrollment closed: Use of a Family Navigator in Families With Children Newly Diagnosed With Autism Spectrum Disorder (clinicaltrials.gov) - Mar 18, 2014
P=N/A, N=192, Active, not recruiting, Sponsor: Boston Medical Center
Recruiting --> Active, not recruiting

||||||||||  risperidone / Generic mfg.
Trial completion:  RUPP PI PDD: Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders (clinicaltrials.gov) -  Feb 22, 2014
P=N/A, N=124, Completed,  Sponsor: Yale University
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

||||||||||  riluzole / Generic mfg.
Trial initiation date:  RILISE: A Pilot Study of Riluzole Versus Placebo in the Treatment of Children and Adolescents With ASD (clinicaltrials.gov) -  Jan 29, 2014
P2, N=60, Recruiting,  Sponsor: Evdokia Anagnostou
Active, not recruiting --> Completed Initiation date: Jun 2013 --> Sep 2013

||||||||||  riluzole / Generic mfg.
Enrollment open:  RILISE: A Pilot Study of Riluzole Versus Placebo in the Treatment of Children and Adolescents With ASD (clinicaltrials.gov) -  Jan 29, 2014
P2, N=60, Recruiting,  Sponsor: Evdokia Anagnostou
Initiation date: Jun 2013 --> Sep 2013 Not yet recruiting --> Recruiting

||||||||||  Circadin (melatonin prolonged release) / Lundbeck, Neurim, Flynn Pharma, Grupo Insud, Biocodex, Kuhnil Pharma
Enrollment open:  Efficacy and Safety of Circadin (clinicaltrials.gov) -  Jan 27, 2014
P3, N=120, Recruiting,  Sponsor: Neurim Pharmaceuticals Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting

|||||||||| Biomarker, Enrollment change: Extracellular Signal-Related Kinase Biomarker Development in Autism (clinicaltrials.gov) - Jan 26, 2014
P=N/A, N=288, Recruiting, Sponsor: Children's Hospital Medical Center, Cincinnati
Not yet recruiting --> Recruiting N=144 --> 288

|||||||||| Enrollment change: Evaluating the Validity of a Genetic Risk Assessment Tool in Identifying Autism Spectrum Disorder (clinicaltrials.gov) - Jan 26, 2014
P=N/A, N=456, Completed, Sponsor: Thomas W. Frazier, Ph.D
N=144 --> 288 N=600 --> 456

|||||||||| Trial completion: Evaluating the Validity of a Genetic Risk Assessment Tool in Identifying Autism Spectrum Disorder (clinicaltrials.gov) - Jan 26, 2014
P=N/A, N=456, Completed, Sponsor: Thomas W. Frazier, Ph.D
N=600 --> 456 Recruiting --> Completed

|||||||||| Enrollment change: SynapDx Autism Gene Expression Analysis Study (STORY) (clinicaltrials.gov) - Jan 21, 2014
P=N/A, N=880, Recruiting, Sponsor: SynapDx
Recruiting --> Completed N=660 --> 880

|||||||||| Enrollment closed: Cognitive Behavioral Therapy for Anxiety Disorders in Adolescents With Autism (clinicaltrials.gov) - Jan 1, 2014
P=N/A, N=50, Active, not recruiting, Sponsor: University of South Florida
N=660 --> 880 Recruiting --> Active, not recruiting

||||||||||  donepezil / Generic mfg.
Enrollment change:  A Trial of the Drug Donepezil for Sleep Enhancement and Behavioral Change in Children With Autism (clinicaltrials.gov) -  Dec 11, 2013
P2, N=90, Recruiting,  Sponsor: National Institute of Mental Health (NIMH)
Recruiting --> Active, not recruiting N=180 --> 90

|||||||||| Trial completion: A Clinical Trial of a New Computer Based Intervention for Children With Autism. (clinicaltrials.gov) - Nov 20, 2013
P0, N=54, Completed, Sponsor: University of Edinburgh
N=180 --> 90 Active, not recruiting --> Completed

||||||||||  l-methylfolate / Generic mfg.
Trial completion:  Trial of Methyl B12 on Behavioral and Metabolic Measures in Children With Autism (clinicaltrials.gov) -  Nov 14, 2013
P2/3, N=55, Completed,  Sponsor: University of California, San Francisco
Active, not recruiting --> Completed Recruiting --> Completed

|||||||||| Trial completion: Cholesterol in ASD: Characterization and Treatment (clinicaltrials.gov) - Nov 14, 2013
P1/2, N=44, Completed, Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Recruiting --> Completed Active, not recruiting --> Completed

||||||||||  atomoxetine / Generic mfg.
Enrollment closed:  Strattera: Atomoxetine, Placebo and Parent Management Training in Autism (clinicaltrials.gov) -  Nov 13, 2013
P4, N=144, Active, not recruiting,  Sponsor: University of Rochester
Active, not recruiting --> Completed Recruiting --> Active, not recruiting

|||||||||| New P2 trial: Transcranial Magnetic Stimulation for Evaluation and Treatment of Repetetive Behaviors in Autism (clinicaltrials.gov) - Nov 11, 2013
P2, N=10, Terminated, Sponsor: New York State Psychiatric Institute

|||||||||| Enrollment change: Neurocircuitry of Autism- fMRI and Transcranial Magnetic Stimulation Studies (clinicaltrials.gov) - Nov 5, 2013
P=N/A, N=8, Terminated, Sponsor: New York State Psychiatric Institute
Recruiting --> Active, not recruiting N=10 --> 8

|||||||||| Trial completion: Social Skills and Anxiety Reduction Treatment for Children and Adolescents With Autism Spectrum Disorders (clinicaltrials.gov) - Nov 5, 2013
P1, N=30, Completed, Sponsor: Virginia Polytechnic Institute and State University
N=10 --> 8 Active, not recruiting --> Completed

|||||||||| New P1 trial: Stem Cell Therapy in Autism Spectrum Disorders (clinicaltrials.gov) - Oct 31, 2013
P1, N=150, Recruiting, Sponsor: Neurogen Brain and Spine Institute

|||||||||| Enrollment open: Sensorimotor Affect Relationship-based Therapy (SMART) for Children With Autism Spectrum Disorders Ages 2-12 (clinicaltrials.gov) - Oct 30, 2013
P=N/A, N=40, Recruiting, Sponsor: Nationwide Children's Hospital
Active, not recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Trial completion: Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine (clinicaltrials.gov) - Oct 30, 2013
P2, N=480, Completed, Sponsor: Forest Laboratories
Not yet recruiting --> Recruiting Active, not recruiting --> Completed

||||||||||  BAER-101 / AstraZeneca, Fortress
New P2 trial:  FAST-AS: Targeting GABA-A for the Treatment of Social Disability in Young Adults With Autism Spectrum Disorders: A Phase II Proof of Mechanism Trial (clinicaltrials.gov) -  Oct 19, 2013
P2, N=40, Not yet recruiting,  Sponsor: University of California, Los Angeles

||||||||||  balovaptan (RG7314) / Roche
Enrollment open:  VANILLA: A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders (ASD) (clinicaltrials.gov) -  Oct 13, 2013
P2, N=130, Recruiting,  Sponsor: Hoffmann-La Roche
Active, not recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Enrollment closed: D-Cycloserine and Social Skills Training in Autism Spectrum Disorders (clinicaltrials.gov) - Oct 10, 2013
P3, N=102, Active, not recruiting, Sponsor: Indiana University
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting

|||||||||| Enrollment change, IO biomarker: Clinical and Immunological Investigations of Subtypes of Autism (clinicaltrials.gov) - Oct 8, 2013
P=N/A, N=546, Completed, Sponsor: National Institute of Mental Health (NIMH)
Recruiting --> Active, not recruiting N=800 --> 546

|||||||||| Trial completion, IO biomarker: Clinical and Immunological Investigations of Subtypes of Autism (clinicaltrials.gov) - Oct 8, 2013
P=N/A, N=546, Completed, Sponsor: National Institute of Mental Health (NIMH)
N=800 --> 546 Recruiting --> Completed

|||||||||| Enrollment closed: Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) (clinicaltrials.gov) - Sep 25, 2013
P2, N=748, Active, not recruiting, Sponsor: Forest Laboratories
Recruiting --> Completed Enrolling by invitation --> Active, not recruiting

|||||||||| Enrollment change: Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine (clinicaltrials.gov) - Sep 19, 2013
P2, N=480, Completed, Sponsor: Forest Laboratories
Enrolling by invitation --> Active, not recruiting N=96 --> 480

|||||||||| Trial completion: An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) (clinicaltrials.gov) - Sep 19, 2013
P2, N=906, Completed, Sponsor: Forest Laboratories
N=96 --> 480 Active, not recruiting --> Completed

|||||||||| New P1 trial: Brain Imaging of Intranasal Oxytocin Treatment in Autism (clinicaltrials.gov) - Sep 17, 2013
P1, N=28, Not yet recruiting, Sponsor: University of North Carolina, Chapel Hill

|||||||||| Trial withdrawal: Mercury Chelation to Treat Autism (clinicaltrials.gov) - Sep 16, 2013
P2, N=0, Withdrawn, Sponsor: National Institute of Mental Health (NIMH)
Active, not recruiting --> Completed Completed --> Withdrawn

|||||||||| Enrollment change: Mercury Chelation to Treat Autism (clinicaltrials.gov) - Sep 16, 2013
P2, N=0, Withdrawn, Sponsor: National Institute of Mental Health (NIMH)
Completed --> Withdrawn N=120 --> 0

|||||||||| Enrollment closed: Omega-3 Fatty Acids For Treatment Of Young Children With Autism (OMG) (clinicaltrials.gov) - Aug 12, 2013
P2, N=40, Active, not recruiting, Sponsor: Evdokia Anagnostou
N=120 --> 0 Recruiting --> Active, not recruiting

|||||||||| Enrollment change: Effect of a Social Script iPAD Application for Children With Autism Spectrum Disorder (clinicaltrials.gov) - Aug 5, 2013
P=N/A, N=32, Completed, Sponsor: Medical College of Wisconsin
Recruiting --> Active, not recruiting N=50 --> 32

|||||||||| Trial completion: Effect of a Social Script iPAD Application for Children With Autism Spectrum Disorder (clinicaltrials.gov) - Aug 5, 2013
P=N/A, N=32, Completed, Sponsor: Medical College of Wisconsin
N=50 --> 32 Recruiting --> Completed

|||||||||| Enrollment open: iPad Application to Treat Prosodic Deficits in Students With Communication Disorders (clinicaltrials.gov) - Aug 4, 2013
P=N/A, N=200, Recruiting, Sponsor: Yale University
Recruiting --> Completed Not yet recruiting --> Recruiting

||||||||||  metformin / Generic mfg.
Enrollment open:  Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD) (clinicaltrials.gov) -  Aug 1, 2013
P3, N=90, Recruiting,  Sponsor: Evdokia Anagnostou
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting

|||||||||| Trial initiation date: Partnering With Autistic Adults to Improve Healthcare (clinicaltrials.gov) - Jul 30, 2013
P=N/A, N=200, Not yet recruiting, Sponsor: Oregon Health and Science University
Not yet recruiting --> Recruiting Initiation date: Aug 2012 --> Aug 2013

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial termination:  Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders (clinicaltrials.gov) -  Jul 29, 2013
P3, N=165, Terminated,  Sponsor: Seaside Therapeutics, Inc.
Initiation date: Aug 2012 --> Aug 2013 Enrolling by invitation --> Terminated

||||||||||  arbaclofen (STX209) / Allos Pharma
Enrollment change:  Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders (clinicaltrials.gov) -  Jul 29, 2013
P2, N=150, Completed,  Sponsor: Seaside Therapeutics, Inc.
Enrolling by invitation --> Terminated N=200 --> 150

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial completion:  Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders (clinicaltrials.gov) -  Jul 29, 2013
P2, N=150, Completed,  Sponsor: Seaside Therapeutics, Inc.
N=200 --> 150 Active, not recruiting --> Completed

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial completion:  Harbor-A: Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome (clinicaltrials.gov) -  Jul 29, 2013
P3, N=125, Completed,  Sponsor: Seaside Therapeutics, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  arbaclofen (STX209) / Allos Pharma
Biomarker, Trial completion:  Biomarker and DNA Collection in Subjects Participating in Protocol 22003 (clinicaltrials.gov) -  Jul 29, 2013
P=N/A, N=32, Completed,  Sponsor: Seaside Therapeutics, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Circadin (melatonin prolonged release) / Lundbeck, Neurim, Flynn Pharma, Grupo Insud, Biocodex, Kuhnil Pharma
New P3 trial:  Efficacy and Safety of Circadin (clinicaltrials.gov) -  Jul 22, 2013
P3, N=120, Recruiting,  Sponsor: Neurim Pharmaceuticals Ltd.

||||||||||  Circadin (melatonin prolonged release) / Lundbeck, Neurim, Flynn Pharma, Grupo Insud, Biocodex, Kuhnil Pharma
New P1 trial:  Assessment of the Pharmacokinetics of Circadin (clinicaltrials.gov) -  Jul 17, 2013
P1, N=16, Completed,  Sponsor: Neurim Pharmaceuticals Ltd.

|||||||||| Trial completion: CCNIA: Developmental and Augmented Intervention for Facilitating Expressive Language (clinicaltrials.gov) - Jul 9, 2013
P=N/A, N=96, Completed, Sponsor: Autism Speaks
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  donepezil / Generic mfg.
New P2 trial:  A Trial of the Drug Donepezil for Sleep Enhancement and Behavioral Change in Children With Autism (clinicaltrials.gov) -  Jun 24, 2013
P2, N=90, Recruiting,  Sponsor: National Institute of Mental Health (NIMH)

|||||||||| Trial initiation date: OMMA: Osteopathic Manual Medicine Treatment in Autism (clinicaltrials.gov) - Jun 10, 2013
P=N/A, N=30, Recruiting, Sponsor: New York Institute of Technology
Active, not recruiting --> Completed Initiation date: Aug 2012 --> Jan 2013

|||||||||| Enrollment open: OMMA: Osteopathic Manual Medicine Treatment in Autism (clinicaltrials.gov) - Jun 10, 2013
P=N/A, N=30, Recruiting, Sponsor: New York Institute of Technology
Initiation date: Aug 2012 --> Jan 2013 Not yet recruiting --> Recruiting