Who is sponsoring NCT01615887?

NCT01615887 is sponsored by State University of New York at Buffalo.

What condition does NCT01615887 study?

NCT01615887 studies Multiple Sclerosis.

What drugs are being tested in NCT01615887?

Interventions: lisdexamfetamine sulfate, placebo.

What is the status of NCT01615887?

NCT01615887 is currently COMPLETED.

Last reviewed 2022-08-23 · How we verify

Effects of Lisdexamfetamine on Bradyphrenia in Multiple Sclerosis

NCT01615887 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	State University of New York at Buffalo
Phase	Phase 2
Status	COMPLETED
Enrolment	63
Start date	2009-11
Completion	2011-08

Conditions

Multiple Sclerosis

Interventions

lisdexamfetamine sulfate
placebo

Primary outcomes

Symbol Digit Modalities Test (SDMT) — 8 weeks
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.
Paced Auditory Serial Audition Test (PASAT) — 8 Weeks
The PASAT is a test requiring attention and vigilance. In this test, the patient listens to a tape recording of digits presented one at a time. The task for the patient is to add each number to the one immediately preceding it. For example, the recording might present the numbers 1, 7, 5, 4. The patient adds the first two numbers (1 + 7) and responds with the number 8. The patient then adds the second two numbers (7 + 5) and responds with the number 12. The patient then adds the third two numbers (5 + 4) and responds with the number 9. This continues for a total of 61 numbers presented in a random order. The patients score is the total number correct out of 60 (Stebbins et al. 2007). The PASAT score ranges from 0 to 60, with higher values representing a better outcome in cognitive processing speed.

Countries

United States