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NCT02635035 · ClinicalTrials.gov registry record · Phase 2
Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT
A Phase 2 study of Attention Deficit Hyperactivity Disorder and Attention Deficit Disorder, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 2
- Study locations
NCT02635035: Completed Phase 2 study of Attention Deficit Hyperactivity Disorder and Attention Deficit Disorder, sponsored by NYU Langone Health.
NCT02635035 is a Phase 2 study of Attention Deficit Hyperactivity Disorder and Attention Deficit Disorder that has completed, run by NYU Langone Health. The registered enrollment target is 38 participants, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02635035, a Phase 2 study of Attention Deficit Hyperactivity Disorder and Attention Deficit Disorder, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 2
- Study locations
Study Summary
The primary purpose of this study is to test the efficacy of Lisdexamfetamine in Adults With Attention Deficit Hyperactivity Disorder (ADHD) and Sluggish Cognitive Tempo (SCT). This is a placebo controlled, cross-over clinical trial of oral Lisdexamfetamine Dimesylate 30-70mg/day in adults with attention-deficit hyper-activity disorder and Sluggish Cognitive Tempo (ACT). Patients will be assigned either LDX/Placebo for 10 weeks with a two week placebo washout period.
Primary Outcome
The BAARS-IV Self-Report consists of 27 symptoms that can be rated from 1 (never or rarely) to 4 (very often). The total range of scores is 1-108; a higher score indicates ADHD symptoms at a higher frequency.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lisdexamfetamine
Study Locations (2)
New York
- Mount Sinai School of Medicine - New York
- New York University School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2015-11 |
| Est. Completion | 2019-01-09 |
| Phase | Phase 2 |
What the finished NCT02635035 record still lists
NCT02635035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02635035 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02635035 about?
NCT02635035 is a clinical study titled "Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT". The primary purpose of this study is to test the efficacy of Lisdexamfetamine in Adults With Attention Deficit Hyperactivity Disorder (ADHD) and Sluggish Cognitive Tempo (SCT). This is a placebo controlled, cross-over clinical trial of oral Lisdexamfetamine Dimesylate 30-70mg/day in adults with atte...
What is the current status of trial NCT02635035?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2015-11. Estimated completion is 2019-01-09.
What conditions does trial NCT02635035 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder.
What interventions are being tested in trial NCT02635035?
The interventions under investigation include: Placebo (DRUG), Lisdexamfetamine (DRUG).
Who is sponsoring clinical trial NCT02635035?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02635035 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02635035's enrollment target sits among peer trials
38 72nd of 102 higher than 29 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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