CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
lisdexamfetamine sulfate +1 moredrug
Likely dose
lisdexamfetamine sulfate 30mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01615887
NCT01615887Phase 2Completed

Effects of Lisdexamfetamine on Bradyphrenia in Multiple Sclerosis

State University of New York at Buffalo·interventional·Posted Jun 11, 2012·Updated Sep 16, 2022

In Brief

A Phase 2 clinical trial evaluating lisdexamfetamine sulfate and placebo for Multiple Sclerosis. Completed, enrolled 63 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 11, 2012
Enrollment StartNov 1, 2009
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.1 years ago

Interventions

lisdexamfetamine sulfatedrug

30mg lisdexamfetamine OD, increased to 70mg OD over 4 weeks and continued on 70mg OD for 4 weeks

placebodrug

sugar pill