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NCT02704390
An Extension Study to Evaluate the Long-term Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD
Phase 3 trial testing ORADUR®-Methylphenidate in Attention Deficit Hyperactivity Disorder in 64 participants. Completed in 1 August 2019.
1 August 2019
Quick facts
| Lead sponsor | Orient Pharma Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 1 January 2016 |
| Primary completion | 1 August 2019 |
| Estimated completion | 1 August 2019 |
| Sites | 3 locations across Taiwan |
Drugs / interventions tested
- ORADUR®-Methylphenidate — full drug profile →
Conditions studied
- Attention Deficit Hyperactivity Disorder — all drugs for Attention Deficit Hyperactivity Disorder →
Sponsor
Orient Pharma Co., Ltd. — full company profile →
Who can join
Adults 6 to 18, any sex, with Attention Deficit Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
SNAP-IV teacher form scores in ORADUR®-Methylphenidate
Time frame: 24 months
Change from baseline of Swanson, Nolan, and Pelham-IV (SNAP-IV) teacher form scores
Sponsor's own description
The purpose of this study is to evaluate the long-term safety and efficacy of ORADUR®-Methylphenidate in children and adolescents with ADHD.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02704390
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Attention Deficit Hyperactivity Disorder
Currently open trials in the same condition.
- NCT07001475 — A Study to Test How BI 3031185 is Tolerated by People With Borderline Personality Disorder or Attention-deficit/Hyperact · Phase 1 · recruiting
- NCT06847165 — Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure · NA · recruiting
- NCT06325813 — ADHD PreSMA Response Inhibition Therapy · NA · recruiting
- NCT06248229 — A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder · Phase 4 · recruiting
- NCT06232226 — Attention Deficit Hyperactivity Disorder · NA · recruiting
Other Orient Pharma Co., Ltd. trials
Trials by the same sponsor.
- NCT04643093 — Compare the Efficacy and Safety of 1PC111 With Pitavastatin and Ezetimibe in Patients With Primary Hypercholesterolemia · Phase 3 · completed
- NCT02467608 — Efficacy of HUEXC030 in Subjects With Pulmonary Tuberculosis · Phase 2, PHASE3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02704390 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Orient Pharma Co., Ltd.
- Last refreshed: 30 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02704390.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing