Clinical trials: Autistic Disorder in Children and Adolescents
- Condition Autistic Disorder in Children and Adolescents
- Funder type Industry (pharma, biotech, devices)
Autistic Disorder
Study of Fluoxetine in Autism
The purpose of this study is to assess the effect of fluoxetine orally dissolving tablets (ODT) on the repetitive behaviors core domain in children and adolescents with Autistic Disorder.
- Trial name
- SOFIA (NCT00515320)
- Testing
- Fluoxetine
- Where
- 17 sites in United States
- Volunteers
- 158 people
- Sponsor
- Neuropharm
Autism Spectrum Disorder, Social Communication Disorder
Safety and Efficacy of NDTx-03 in Children and Adolescents With ASD or SCD
The purpose of this study is to evaluate the safety of NDTx-03 used together with treatment as usual (TAU) and to determine whether NDTx-03 plus TAU is more effective than TAU alone in improving social situation recognition and…
- Trial name
- NCT07770867
- Testing
- NDTx-03, TAU
- Where
- 7 sites in South Korea
- Volunteers
- 156 people
- Sponsor
- Neudive Inc.
Autistic Disorder
Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Autistic Disorder
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, tolerability and the steady-state plasma trough concentration of aripiprazole flexible-dosed in children…
- Trial name
- NCT03487770
- Testing
- Aripiprazole Oral Solution
- Where
- China
- Volunteers
- 111 people
- Sponsor
- Otsuka Beijing Research Institute
Autism Spectrum Disorder
A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder
The purpose of this study is to evaluate the efficacy of JNJ-42165279 compared with placebo in the improvement of symptoms of Autism Spectrum Disorder (ASD) during 12 weeks of treatment using the Autism Behavior Inventory (ABI).
- Trial name
- Envision (NCT03664232)
- Testing
- JNJ-42165279
- Where
- 9 sites in United States
- Volunteers
- 78 people
- Sponsor
- Janssen Research & Development, LLC
Autism Spectrum Disorder
ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)
ML-004-003 is a multi-center, open-label extension study that will enroll approximately 120 adolescent and adult subjects with ASD that have completed study ML-004-002.
- Trial name
- NCT05889273
- Testing
- ML-004 (IR)/(ER) tablet
- Where
- 21 sites in United States, Australia and 1 more
- Volunteers
- 120 people
- Sponsor
- MapLight Therapeutics
Behavioral Symptoms, Autistic Disorder
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
- Trial name
- NCT00337571
- Testing
- Aripiprazole
- Where
- 31 sites in United States
- Volunteers
- 218 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Irritability Associated With Autism Spectrum Disorder
Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148
The purpose of this study is to evaluate the long-term safety and tolerability of brexpiprazole in children and adolescent participants, aged 5 to 17, with irritability associated with autism spectrum disorder.
- Trial name
- NCT04258839
- Testing
- Brexpiprazole
- Where
- 28 sites in United States
- Volunteers
- 95 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Agitation in Adolescents and Young Adults With ASD
INP105 Proof-of-concept Study for the Acute Treatment of Agitation in Adolescents and Young Adults With ASD
This is a Phase 2a, proof-of concept, 2-way, 2-period crossover, double-blind study to evaluate the safety and efficacy of INP105 as an acute treatment versus placebo in adolescents and young adults with autism spectrum disorder…
- Trial name
- CALM 201 (NCT05163717)
- Testing
- INP105
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Impel Pharmaceuticals
Autistic Disorder, Behavioral Symptoms
Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)
This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 [NCT00332241]…
- Trial name
- NCT00365859
- Testing
- Aripiprazole
- Where
- 55 sites in United States
- Volunteers
- 330 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autism Spectrum Disorder (ASD)
Evaluate the Efficacy and Safety of TTYP01 Tablets in Adolescents and Children With ASD
This is a multi-center, randomized, double-blind, multiple dose levels, parallal group, placebo-controlled study, to evaluate the safety, PK profiles and preliminary efficacy of TTYP01 tablets in adolescents and children with ASD.
- Trial name
- NCT06757504
- Testing
- TTYP01 Tablets (12mg or 18mg)
- Where
- 5 sites in China
- Volunteers
- 150 people
- Sponsor
- Shanghai Auzone Biological Technology Co., Ltd.
Autism Spectrum Disorder, Social Communication Disorder
To Evaluate the Efficacy and Safety of 'NDTx-01' in Patients With ASD or SCD
The purpose of this study is to demonstrate the superiority of the treatment of cognitive therapy software 'NDTx-01' compared to TAU (Treatment-As-Usual).
- Trial name
- NCT06446193
- Testing
- NDTx-01, TAU
- Where
- 5 sites in South Korea
- Volunteers
- 86 people
- Sponsor
- Neudive Inc.
Schizophrenia, Autism-Related Irritability
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
The purpose of this study is to evaluate the long-term safety and tolerability of Xanomeline and Trospium Chloride for the treatment of psychiatric disorders in children and adolescents
- Trial name
- NCT07424404
- Testing
- KarXT, KarX-EC
- Where
- 104 sites in United States, Australia and 9 more
- Volunteers
- 400 people
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Irritability Associated With Autism Spectrum Disorder
A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
- Trial name
- NCT07284745
- Testing
- KarXT, KarX-EC
- Where
- 39 sites in United States, Australia and 2 more
- Volunteers
- 176 people
- Sponsor
- Bristol-Myers Squibb
Autism Spectrum Disorder, Autism
A 12-Week Crossover Study to Assess the Efficacy, Safety and Tolerability of L1-79 in Subjects Aged 12-21 Years With Autism Spectrum Disorder
This study will investigate the efficacy, safety and tolerability of L1-79 in participants aged 12-21 years who have been diagnosed with ASD with a score of >/= 70 on the Wechsler Abbreviated Scale of Intelligence (WASI-II), and…
- Trial name
- NCT05067582
- Testing
- L1-79
- Where
- 8 sites in United States
- Volunteers
- 58 people
- Sponsor
- Yamo Pharmaceuticals LLC
Circadian Rhythm Sleep Disorders, Non-24 Hour Sleep-Wake Disorder
Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents
Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents.
- Conditions
- Circadian Rhythm Sleep Disorders, Non-24 Hour Sleep-Wake Disorder, Autism Spectrum Disorder, Smith-Magenis Syndrome
- Trial name
- NCT02776215
- Testing
- tasimelteon
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Vanda Pharmaceuticals
Autistic Disorder, Attention Deficit Disorder With Hyperactivity
Atomoxetine Versus Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents With Autism Spectrum Disorder
The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD (Attention Deficit/Hyperactivity Disorder) symptoms in children and adolescents with ASD (Autism Spectrum Disorder).
- Trial name
- NCT00380692
- Testing
- Atomoxetine
- Where
- 8 sites in Netherlands
- Volunteers
- 97 people
- Sponsor
- Eli Lilly and Company
Fragile X Syndrome
Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome
To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in adolescents and adults with fragile X syndrome (FXS)
- Trial name
- Harbor-A (NCT01282268)
- Testing
- arbaclofen
- Where
- 24 sites in United States
- Volunteers
- 125 people
- Sponsor
- Seaside Therapeutics, Inc.
Irritability Associated With Autism Spectrum Disorder (ASD)
Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
The purpose of this study is to find out about the potential benefits and safety of brexpiprazole in children and adolescent participants, aged 5 to 17, with irritability associated with autism spectrum disorder.
- Trial name
- NCT04174365
- Testing
- Brexpiprazole
- Where
- United States
- Volunteers
- 119 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autism
Safety of L1-79 in Adolescent and Adult Males With Autism
This is a five-arm designed to assess the safety of L1-79 that incorporates 15 prospectively randomized, placebo controlled patients and 5 open label patients at either 100 tid (three times daily) or 200 tid dosing for 28 days.
- Trial name
- NCT02947048
- Testing
- L1-79
- Where
- 2 sites in United States
- Volunteers
- 42 people
- Sponsor
- Yamo Pharmaceuticals LLC
Autistic Disorder
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
The objective of this study is to investigate the safety and efficacy of aripiprazole orally administered over long term in subjects who complete a short-term treatment study of pediatric Autistic Disorder (031-11-002 study).
- Trial name
- NCT01617460
- Testing
- Aripiprazole
- Where
- 5 sites in Japan
- Volunteers
- 86 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.