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NCT01615887 · ClinicalTrials.gov registry record · Phase 2
Study of Lisdexamfetamine Sulfate to Treat Cognitive Dysfunction in Multiple Sclerosis
A Phase 2 study, sponsored by State University of New York at Buffalo.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT01615887: Completed Phase 2 study, sponsored by State University of New York at Buffalo.
NCT01615887 is a Phase 2 study that has completed, run by State University of New York at Buffalo. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01615887, a Phase 2 study, has completed, sponsored by State University of New York at Buffalo.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
Amphetamines have been shown to improve cognition but its use is limited due to its side effects. Lisdexamfetamine is an amphetamine pro-drug, minimizing these effects and has been safely used in children and adults with Attention Deficit Hyperactivity Disorder (ADHD). The investigators hypothesize that lisdexamfetamine may improve cognitive abilities in MS patients with documented cognitive dysfunction. Because lisdexamfetamine is a stimulant its positive effects should be observed primarily in the domains of processing speed and working memory. The investigators therefore propose a study in which the primary objective will be to assess the efficacy of lisdexamfetamine in improving attention and processing speed in MS. The secondary objectives will be (a) the assessment of the safety and tolerability of lisdexamfetamine in the MS population, and (b) to test for effects of the drug on other cognitive domains, depression, and self and informant reports of cognitive and executive function demanding activities and behaviors.
Primary Outcome
The Symbol Digit Modalities Test (SDMT) presents a series of nine symbols, each paired with a single digit in a key at the top of a stimulus page. Subjects voice the number associated with each symbol as rapidly as possible. The examiner records the total amount of responses completed. The task continues for 90 seconds with the research staff recording responses. The SDMT score ranges from 0 to 110, with higher values representing a better outcome in cognitive processing speed.
Interventions
- DRUG placebo
- DRUG lisdexamfetamine sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
What the finished NCT01615887 record still lists
NCT01615887 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01615887 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01615887 about?
NCT01615887 is a clinical study titled "Study of Lisdexamfetamine Sulfate to Treat Cognitive Dysfunction in Multiple Sclerosis". Amphetamines have been shown to improve cognition but its use is limited due to its side effects. Lisdexamfetamine is an amphetamine pro-drug, minimizing these effects and has been safely used in children and adults with Attention Deficit Hyperactivity Disorder (ADHD). The investigators hypothesize ...
What is the current status of trial NCT01615887?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2009-11. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01615887?
The interventions under investigation include: placebo (DRUG), lisdexamfetamine sulfate (DRUG).
Who is sponsoring clinical trial NCT01615887?
This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01615887's enrollment target sits among peer trials
63 1009th of 2000 higher than 985 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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