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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 is a Phase 3 study that has completed, run by Tris Pharma. The registered enrollment target is 18 participants.

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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.

Interventions

  • DRUG amphetamine extended-release oral suspension, 2.5 mg/mL
  • DRUG Placebo extended-release oral suspension

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2017-02-11
Est. Completion 2017-10-30
Phase Phase 3

Sponsor

Tris Pharma

14 total trials

What the Registry Record Tells You About NCT03088267

The ClinicalTrials.gov registry entry for NCT03088267 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tris Pharma, which has 14 total studies on file at ClinicalTrials.gov.

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 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.