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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 is a Phase 2 study that has completed, run by State University of New York at Buffalo. The registered enrollment target is 63 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01615887
The ClinicalTrials.gov registry entry for NCT01615887 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is State University of New York at Buffalo, which has 243 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01615887 reports 0 study locations.
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.
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