Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03088267 · ClinicalTrials.gov registry record · Phase 3
Dyanavel® XR Extended-Release Oral Suspension in the Treatment of Children With ADHD: A Laboratory School Study
A Phase 3 study, sponsored by Tris Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 18
- Enrollment target
NCT03088267: Completed Phase 3 study, sponsored by Tris Pharma.
NCT03088267 is a Phase 3 study that has completed, run by Tris Pharma. The registered enrollment target is 18 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03088267, a Phase 3 study, has completed, sponsored by Tris Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 18 participants
- Enrollment target
Study Summary
This study was conducted to assess the efficacy and safety of DYANAVEL XR (amphetamine extended-release oral suspension, CII) for the treatment of symptoms of attention-deficit/hyperactivity disorder (ADHD) in children aged 6-12 years.
Primary Outcome
Change in SKAMP-C (Swanson, Kotkin, Agler, M-Flynn, and Pelham combined) score from pre-dose, by treatment. The SKAMP-C is a rating scale that assesses functional impairment related to ADHD in the classroom, including the performance of academic tasks, following class rules, and interacting with peers and adults in the classroom. The SKAMP-C is a 13-item, 7-score rating system (0=normal to 7=maximal impairment). The higher the score, the worse the impairment. A decrease from baseline in the comb
Interventions
- DRUG amphetamine extended-release oral suspension, 2.5 mg/mL
- DRUG Placebo extended-release oral suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2017-02-11 |
| Est. Completion | 2017-10-30 |
| Phase | Phase 3 |
What the finished NCT03088267 record still lists
NCT03088267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which amphetamine extended-release oral suspension, 2.5 mg/mL is the first listed.
NCT03088267 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03088267 about?
NCT03088267 is a clinical study titled "Dyanavel® XR Extended-Release Oral Suspension in the Treatment of Children With ADHD: A Laboratory School Study". This study was conducted to assess the efficacy and safety of DYANAVEL XR (amphetamine extended-release oral suspension, CII) for the treatment of symptoms of attention-deficit/hyperactivity disorder (ADHD) in children aged 6-12 years.
What is the current status of trial NCT03088267?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 18 participants. The study started on 2017-02-11. Estimated completion is 2017-10-30.
What interventions are being tested in trial NCT03088267?
The interventions under investigation include: amphetamine extended-release oral suspension, 2.5 mg/mL (DRUG), Placebo extended-release oral suspension (DRUG).
Who is sponsoring clinical trial NCT03088267?
This trial is sponsored by Tris Pharma, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03088267's enrollment target sits among peer trials
18 1970th of 2000 higher than 30 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01245179 · 18 participants · Phase 1
Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease
- NCT01999361 · 18 participants · NA
Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
- NCT02359825 · 18 participants · Phase 1
Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function
- NCT02870244 · 18 participants · Phase 1
Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI