Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01101022 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy of SPD489 on Executive Function Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 4 study, sponsored by Shire.
- Completed
- Registry status
- Phase 4
- Development phase
- 161
- Enrollment target
NCT01101022: Completed Phase 4 study, sponsored by Shire.
NCT01101022 is a Phase 4 study that has completed, run by Shire. The registered enrollment target is 161 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01101022, a Phase 4 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 161 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo on executive function (self-regulation) behaviors in adults with ADHD who report clinically significant impairment of executive function behavior in their everyday environment, as measured by the self-report Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Global Executive Composite (GEC) T-score.
Primary Outcome
BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Interventions
- OTHER Placebo
- DRUG SPD489
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2010-05-19 |
| Est. Completion | 2010-11-29 |
| Phase | Phase 4 |
What the finished NCT01101022 record still lists
NCT01101022 is an interventional study that assigns participants to a tested intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01101022 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01101022 about?
NCT01101022 is a clinical study titled "Safety and Efficacy of SPD489 on Executive Function Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)". The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo on executive function (self-regulation) behaviors in adults with ADHD who report clinically significant impairment of executive function behavior in their everyday environment, as measured by the self-report...
What is the current status of trial NCT01101022?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 161 participants. The study started on 2010-05-19. Estimated completion is 2010-11-29.
What interventions are being tested in trial NCT01101022?
The interventions under investigation include: Placebo (OTHER), SPD489 (DRUG).
Who is sponsoring clinical trial NCT01101022?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01101022's enrollment target sits among peer trials
161 506th of 2000 higher than 1,494 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
- NCT06391034 · 161 participants · Phase 2
Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer
- NCT06546670 · 161 participants · Phase 1
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
- NCT06616766 · 161 participants · Phase 1
A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946
- NCT06752356 · 161 participants · Phase 3
A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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