Clinical trials: Development, Adolescent
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 Spectrum Disorder
Trial to Investigate the Safety and Efficacy of Cannabidiol Oral Solution (GWP42003-P; CBD-OS) in Children and Adolescents With Autism Spectrum Disorder
This study will be conducted to evaluate the efficacy of GWP42003-P, compared with placebo, in reducing symptom severity in children with Autism Spectrum Disorder (ASD).
- Trial name
- NCT04745026
- Testing
- GWP42003-P
- Where
- 23 sites in United States, Australia and 4 more
- Volunteers
- 103 people
- Sponsor
- Jazz Pharmaceuticals
Attention-Deficit/Hyperactivity Disorder, Autism Spectrum Disorder
A Pilot Study on Efficacy of Digital Therapeutic NDTx-02 for Executive Function in Children and Adolescents With ADHD or ASD
The purpose of this study is to explore the preliminary safety and effectiveness of the digital therapeutic device 'NDTx-02' in supporting improvements of executive function in children and adolescents diagnosed with…
- Trial name
- NCT07242625
- Testing
- NDTx-02 + TAU, TAU
- Where
- 3 sites in South Korea
- Volunteers
- 48 people
- Sponsor
- Neudive Inc.
Autism Spectrum Disorder
A Study to Evaluate Scales for Repetitive and Restricted Behaviors in Children, Adolescents, and Adults With Autism Spectrum Disorder (ASD)
This is a non-drug study seeking to characterize different scales to measure repetitive and restrictive behaviors in different ASD sub-populations over time. This study will also explore the use of digital biomarkers.
- Trial name
- NCT03611075
- Testing
- No Intervention
- Where
- 18 sites in United States, Canada and 1 more
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Autism Spectrum Disorder (ASD)
TeleABA for Hospitalized Adolescents and Young Adults With Autism Spectrum Disorder
This study is evaluating whether a telehealth-based applied behavior analysis (ABA) program can improve the care of adolescents and young adults with autism spectrum disorder (ASD) who are hospitalized because of severe…
- Trial name
- NCT07701915
- Testing
- Standard Hospital Care, Telehealth Applied Behavior Analysis (TeleABA)
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- Caring Technologies, Inc.
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
Autistic Disorder
A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
The objective of this study is to investigate the efficacy and safety of aripiprazole orally administered over a period of 8 weeks in pediatric patients with Autistic Disorder
- Trial name
- NCT01617447
- Testing
- Aripiprazole
- Where
- 5 sites in Japan
- Volunteers
- 92 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
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.
Autism Spectrum Disorder
ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)
ML-004-002 is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study that will enroll approximately 150 adolescent and adult subjects with ASD.
- Trial name
- NCT05081245
- Testing
- ML-004 (IR)/(ER) tablet
- Where
- 29 sites in United States, Australia and 1 more
- Volunteers
- 168 people
- Sponsor
- MapLight Therapeutics
Autistic Disorder, Autism
A Study of the Effectiveness and Safety of Two Doses of Risperidone in the Treatment of Children and Adolescents With Autistic Disorder
The purpose of this study is to evaluate the effectiveness (change in level of irritability and related behaviors) and safety and tolerability of the administration of 2 different fixed dose levels of risperidone (an atypical…
- Trial name
- NCT00576732
- Testing
- Risperidone high dose, Risperidone low dose
- Where
- 20 sites in United States
- Volunteers
- 96 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Achondroplasia
A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia
This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of infigratinib in children and adolescents with achondroplasia (ACH) who have completed at least 26 weeks of…
- Trial name
- PROPEL3 (NCT06164951)
- Testing
- Infigratinib 0.25 mg/kg/day
- Where
- 27 sites in United States, Argentina and 8 more
- Volunteers
- 114 people
- Sponsor
- QED Therapeutics, a BridgeBio company
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
Congenital Adrenal Hyperplasia
Safety, Pharmacokinetics and Pharmacodynamics of NBI-77860 in Adolescent Females With Congenital Adrenal Hyperplasia
This is a Phase 1, multicenter, open-label, single-dose study to evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-77860 in subjects with congenital adrenal hyperplasia (CAH).
- Trial name
- NCT02349503
- Testing
- NBI-77860
- Where
- 2 sites in United States
- Sponsor
- Neurocrine Biosciences
Osteogenesis Imperfecta
Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and…
- Trial name
- NCT05972551
- Testing
- Romosozumab, Bisphosphonate
- Where
- 65 sites in United States, Australia and 16 more
- Volunteers
- 111 people
- Sponsor
- Amgen
Autism Spectrum Disorder, Autism
Autism Spectrum Disorder (ASD) Neurodevelopmental Disorder With Issues Social Behavior, Communication Issues, GI Dysfunction. Study is Multimodal Interventions Targeting These Pathways With cSVF, Stored MSCs, FMT and Diet Modification. Role of Autoimmunity, Gut-brain Issues, & Issues Examined.
Autism spectrum disorder (ASD) is a neurodevelopmental condition with core deficits in social communication and behavior, often accompanied by gastrointestinal (GI) and metabolic dysfunction.
- Conditions
- Autism Spectrum Disorder, Autism, Autism Spectral Disorder
- Trial name
- GARM-Autism (NCT07546942)
- Testing
- Autologous MSC isolation, concentration, and cryopreservation of adult mesenchymal stem cells, Fecal Biomicrome Transplantation (FMT), Ketogenic RESET Diet Protocol
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Black Tie Medical, Inc.
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
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.
Autistic Disorder
Extended Management and Measurement of Autism
This open-label research study will continue to monitor the safety of fluoxetine in children after their completion of a previous double-blind placebo controlled clinical study, with fluoxetine.
- Trial name
- EMMA (NCT00787111)
- Testing
- Fluoxetine (prozac)
- Where
- 13 sites in United States
- Volunteers
- 128 people
- Sponsor
- Neuropharm
Irritability Associated With Autism Spectrum Disorder
A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder
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
- NCT07285798
- Testing
- KarXT, KarX-EC
- Where
- 67 sites in United States, France and 8 more
- Volunteers
- 176 people
- Sponsor
- Bristol-Myers Squibb