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NCT01010750 · ClinicalTrials.gov registry record · Phase 1
Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
A Phase 1 study of Attention Deficit Hyperactivity Disorder, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT01010750: Completed Phase 1 study of Attention Deficit Hyperactivity Disorder, sponsored by Shire.
NCT01010750 is a Phase 1 study of Attention Deficit Hyperactivity Disorder that has completed, run by Shire. The registered enrollment target is 18 participants, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01010750, a Phase 1 study of Attention Deficit Hyperactivity Disorder, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
To evaluate the sensitivity and responsiveness of a standardized, validated, computer-based, battery of neuro-psychometric tests in adults with ADHD.
Primary Outcome
The Power of Attention score reflects the ability to focus attention, and is calculated as the sum of the reaction time, measured in milliseconds, from 3 attention tests (Simple Reaction Time, Choice Reaction Time, and Digit Vigilance Speed). Faster performance (lower times) reflects more intense concentration. A decrease in the Power of Attention score indicates improvement.
Conditions Studied
Interventions
- DRUG Lisdexamfetamine Dimesylate (LDX)
- DRUG Immediate Release Mixed Amphetamine Salts (MAS-IR)
- DRUG LDX Placebo + MAS-IR Placebo
Study Locations (1)
Texas
- Claghorn-Lesem Research Clinic - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2010-01-05 |
| Est. Completion | 2010-03-28 |
| Phase | Phase 1 |
What the finished NCT01010750 record still lists
NCT01010750 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 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 3 interventions - of which Lisdexamfetamine Dimesylate (LDX) is the first listed.
NCT01010750 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01010750 about?
NCT01010750 is a clinical study titled "Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)". To evaluate the sensitivity and responsiveness of a standardized, validated, computer-based, battery of neuro-psychometric tests in adults with ADHD.
What is the current status of trial NCT01010750?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2010-01-05. Estimated completion is 2010-03-28.
What conditions does trial NCT01010750 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder.
What interventions are being tested in trial NCT01010750?
The interventions under investigation include: Lisdexamfetamine Dimesylate (LDX) (DRUG), Immediate Release Mixed Amphetamine Salts (MAS-IR) (DRUG), LDX Placebo + MAS-IR Placebo (DRUG).
Who is sponsoring clinical trial NCT01010750?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01010750 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Attention Deficit Hyperactivity Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01010750's enrollment target sits among peer trials
18 97th of 102 higher than 5 of 102 other Attention Deficit Hyperactivity Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder 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.
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