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NCT01274221
Safety and Efficacy of SPD489 in Adolescent Subjects Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)
Phase 3 trial testing SPD489 in ADHD. Withdrawn.
4 May 2011
Quick facts
| Lead sponsor | Shire |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Start date | 6 March 2011 |
| Primary completion | 4 May 2011 |
| Estimated completion | 4 May 2011 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- SPD489 — full drug profile →
- Placebo
Conditions studied
- ADHD — all drugs for ADHD →
Sponsor
Shire — full company profile →
Who can join
Adults 13 to 17, any sex, with ADHD. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo in adolescent subjects (13-17 years of age inclusive) with ADHD in the analog classroom setting based on the Permanent Product Measure of Performance (PERMP) total score assessed across 2, 4, 9, 13, 14, and 15 hours post-dose on the last day of each double-blind crossover period.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01274221
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SPD489
Trials testing the same drug.
- NCT03260205 — Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD) · Phase 3 · completed
- NCT02466386 — Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years, Diagnosed With Attention-deficit/Hyperacti · Phase 3 · completed
- NCT02402166 — Safety, Tolerability, Pharmacokinetic, and Efficacy Study of SPD489 in Preschool Children With Attention-deficit/Hyperac · Phase 2 · completed
- NCT01760993 — Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Nega · Phase 3 · terminated
- NCT01101022 — Safety and Efficacy of SPD489 on Executive Function Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (A · Phase 4 · completed
Other recruiting trials for ADHD
Currently open trials in the same condition.
- NCT07314333 — A Trial to Assess How Centanafadine Interacts With Stimulants in the Body · Phase 1 · recruiting
- NCT07262853 — Dual Executive Function Training Package · NA · recruiting
- NCT07291453 — Loving Habits: A Feasibility Study of a Support Program for Building New Parent-child Behavioral Habits · NA · recruiting
- NCT07281092 — Comparative Efficacy of Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI) · NA · recruiting
- NCT07219810 — Accelerated iTBS Targeting of Working Memory Versus Inhibitory Control in Adolescent ADHD · NA · recruiting
Other Shire trials
Trials by the same sponsor.
- NCT05067868 — A Study of Replagal in Children and Adults With Fabry Disease in India · Phase 4 · recruiting
- NCT03878953 — A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism · Phase 3 · withdrawn
- NCT04840667 — A Study of Replagal in Treatment-naïve Adults With Fabry Disease · Phase 3 · terminated
- NCT04429984 — Post Marketing Surveillance (PMS) Study for Velaglucerase Alfa (VPRIV) in India · completed
- NCT04440488 — ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study · Phase 4 · withdrawn
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 NCT01274221 (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 Shire
- Last refreshed: 3 June 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/NCT01274221.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing