Trial · NCT01615887

Study of Lisdexamfetamine Sulfate to Treat Cognitive Dysfunction in Multiple Sclerosis

NCT01615887, Phase 2, Completed, State University of New York at Buffalo; results first posted 2022-09-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Lisdexamfetamine Sulfate to Treat Cognitive Dysfunction in Multiple Sclerosis. Trials, record NCT01615887. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01615887

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Lisdexamfetamine Sulfate to Treat Cognitive Dysfunction in Multiple Sclerosis
NCT number: NCT01615887
Status: Completed
Phases: Phase 2
Enrollment: 63 participants, actual
Lead sponsor: State University of New York at Buffalo
Conditions: Multiple Sclerosis
Interventions: lisdexamfetamine sulfate, placebo
First posted: 2012-06-11
Last updated: 2022-09-16
Results first posted: 2022-09-16

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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.
Primary	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.
Secondary	California Verbal Learning Test - 2nd Edition	8 weeks	The California Verbal Learning Test Second Edition (CVLT2) begins with the examiner reading a list of 16 words. Patients listen to the list and report as many of the items as possible. After recall is recorded, the entire list is read again. Altogether, there are five learning trials, the total correct of all trials is summed together creating a total verbal learning score. The CVLT-II total verbal learning score ranges from 0 to 80, with higher values representing a better outcome in verbal learning/memory.
Secondary	Brief Visuospatial Memory Test - Revised	8 weeks	The Brief Visuospatial Memory Test Revised (BVMTR) presents six abstract designs for 10 seconds. The display is removed from view and patients render the stimuli via pencil on paper manual responses. There are three learning trials in which patients attempt to replicate the stimuli previously presented. Patients are given a score for all three trials based on correct location and accuracy of the replicated stimuli. Each trial can be awarded up to 12 points, the sum of total points awarded across all three trials is the total learning score. The BVMT-R total learning score ranges from 0 to 36, with higher values representing a better outcome in visuospatial learning/memory.
Secondary	Vitals	8 weeks	Heart rate
Secondary	Vitals (Diastolic Blood Pressure)	8 weeks	diastolic blood pressure
Secondary	Vitals (Systolic Blood Pressure)	8 weeks	systolic blood pressure

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Symbol Digit Modalities Test (SDMT)	8 weeks	score on a scale	MEAN
PRIMARY	Paced Auditory Serial Audition Test (PASAT)	8 Weeks	score on a scale	MEAN
SECONDARY	California Verbal Learning Test - 2nd Edition	8 weeks	score on a scale	MEAN
SECONDARY	Brief Visuospatial Memory Test - Revised	8 weeks	score on a scale	MEAN
SECONDARY	Vitals	8 weeks	beats/min	MEAN
SECONDARY	Vitals (Diastolic Blood Pressure)	8 weeks	mm hg (millimeters of mercury)	MEAN
SECONDARY	Vitals (Systolic Blood Pressure)	8 weeks	mm hg (millimeters of mercury)	MEAN

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Symbol Digit Modalities Test (SDMT)	Lisdexamfetamine Sulfate	36.9	Standard Deviation 8.7	score on a scale
Symbol Digit Modalities Test (SDMT)	Sugar Pill	46.8	Standard Deviation 7.5	score on a scale
Paced Auditory Serial Audition Test (PASAT)	Lisdexamfetamine Sulfate	32.0	Standard Deviation 12.5	score on a scale
Paced Auditory Serial Audition Test (PASAT)	Sugar Pill	37.4	Standard Deviation 12.1	score on a scale
California Verbal Learning Test - 2nd Edition	Lisdexamfetamine Sulfate	44.9	Standard Deviation 11.5	score on a scale
California Verbal Learning Test - 2nd Edition	Sugar Pill	49.2	Standard Deviation 10.2	score on a scale
Brief Visuospatial Memory Test - Revised	Lisdexamfetamine Sulfate	15.2	Standard Deviation 6.1	score on a scale
Brief Visuospatial Memory Test - Revised	Sugar Pill	18.7	Standard Deviation 5.5	score on a scale
Vitals	Lisdexamfetamine Sulfate	72.3	Standard Deviation 11.7	beats/min
Vitals	Sugar Pill	76.9	Standard Deviation 10.6	beats/min

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lisdexamfetamine Sulfate	41
Overall Study	STARTED	Sugar Pill	22
Overall Study	COMPLETED	Lisdexamfetamine Sulfate	29
Overall Study	COMPLETED	Sugar Pill	19
Overall Study	NOT COMPLETED	Lisdexamfetamine Sulfate	12
Overall Study	NOT COMPLETED	Sugar Pill	3

Source ClinicalTrials.gov

Adverse events32

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	dry mouth	Gastrointestinal disorders	Lisdexamfetamine Sulfate	15	41
other	dry mouth	Gastrointestinal disorders	Sugar Pill	2	22
other	nausea	Gastrointestinal disorders	Lisdexamfetamine Sulfate	5	41
other	nausea	Gastrointestinal disorders	Sugar Pill	1	22
other	palpitations	Cardiac disorders	Lisdexamfetamine Sulfate	5	41
other	palpitations	Cardiac disorders	Sugar Pill	1	22
other	increased heart rate	Cardiac disorders	Lisdexamfetamine Sulfate	11	41
other	increased heart rate	Cardiac disorders	Sugar Pill	2	22
other	Increased systolic blood pressure	Cardiac disorders	Lisdexamfetamine Sulfate	4	41
other	Increased systolic blood pressure	Cardiac disorders	Sugar Pill	1	22

1 to 10 of 32Source ClinicalTrials.gov

See all 32 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lisdexamfetamine Sulfate
Total, all-cause mortality	Sugar Pill
Total, other adverse events	Lisdexamfetamine Sulfate	23	41
Total, other adverse events	Sugar Pill	12	22
Total, serious adverse events	Lisdexamfetamine Sulfate	0	41
Total, serious adverse events	Sugar Pill	0	22

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Lisdexamfetamine Sulfate vs Sugar Pill: serious adverse events

Source Trial comparisons

Tests3

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Paced Visual Serial Addition Test	Primary outcome	ConductCognition
Symbol Coding	Primary outcome	ConductCognition
Verbal Learning	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01615887

GET https://conductscience.org/api/trials/v1/NCT01615887/events?page=2

API reference For AI assistants