Study of Lisdexamfetamine Sulfate to Treat Cognitive Dysfunction in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01615887
Recruitment Status : Completed
First Posted : June 11, 2012
Last Update Posted : June 11, 2012
Information provided by (Responsible Party):
State University of New York at Buffalo

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: lisdexamfetamine sulfate Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Lisdexamfetamine on Bradyphrenia in Multiple Sclerosis
Study Start Date : November 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: lisdexamfetamine sulfate
30mg lisdexamfetamine OD, increased to 70mg OD over 4 weeks and continued on 70mg OD for 4 weeks
Drug: lisdexamfetamine sulfate
30mg lisdexamfetamine OD, increased to 70mg OD over 4 weeks and continued on 70mg OD for 4 weeks
Other Name: Vyvanse
Placebo Comparator: Sugar pill
Placebo will be administered in the same fashion as the treatment arm
Drug: placebo
sugar pill

Primary Outcome Measures :
  1. Symbol Digit Modalities Test SDMT) and Paced Auditory Serial Addition Test [ Time Frame: 8 weeks ]
    Measures of Processing Speed

Secondary Outcome Measures :
  1. California Verbal Learning Test - 2nd edition [ Time Frame: 8 weeks ]
    Measure of verbal memory

  2. Brief Visuospatial Memory Test - Revised [ Time Frame: 8 weeks ]
    Visual memory test

  3. vitals [ Time Frame: 8 weeks ]
    Heart rate and blood pressure

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males/Females who are ≥ 18 years old and < 55 years old and are capable of understanding and complying with the protocol, including speaking and writing fluent English and having at least a 9th grade education.
  • Have a diagnosis of either Relapsing Remitting or Secondary Progressive MS, as per revised McDonald's Criteria (68).
  • Have not received steroids in last thirty (30) days or a relapse in the last ninety (90) days, and whose MS is considered stable.
  • Presence of cognitive dysfunction characterized by slowed processing speed as indicated by a score of -1.5 SD below age/education matched norms on the SDMT or the PASAT.
  • An Expanded Disability Status Scale (EDSS) of ≤ 6.5
  • Have given written informed consent prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care.
  • Are capable of performing the requirements of a NP test battery including at least 20/70 near visual acuity by near vision chart, with correction allowed.
  • If female, must neither be pregnant nor breast-feeding and must either (a) be > 12 months post-menopausal or surgically sterilized, or (b) agree to use an acceptable method of birth control for the duration of the study. Abstinence will not be considered an acceptable method of birth control.

Exclusion Criteria:

  • Have cognitive deficits caused by concomitant medication usage or other significant neurological/psychological disease e.g. Alzheimer's disease, Parkinson's disease, stroke, transient ischemic attack, Vascular Dementia, Huntington's disease, traumatic brain injury or chronic CNS infection
  • Have evidence of other medical cause(s) of cognitive impairment
  • Have evidence of major depression as determined by a positive BDIFS and clinician interview
  • Have uncontrolled or labile hypertension, tachycardia, cardiovascular or cerebrovascular disease
  • Have demonstrated a hypersensitivity to amphetamines in the past
  • The following concomitant medications are not permitted to be used within 28 days of enrollment or during the study

    • Monoamine Oxidase Inhibitors
    • Inhaled Beta2-agonists
    • Sympathomimetics
    • Antipsychotic agents
    • Modafinil
    • Tricyclic Antidepressants
    • Anticonvulsants other than gabapentin and pregabalin
  • The following medications are permitted if the patient has been on a stable dose for ≥ 6 weeks:

    • Short acting benzodiazepines, qhs administration only
    • Gabapentin and pregabalin Cholinesterase inhibitors other than donepezil, galantamine, and rivastigmine
    • Memantine
    • Anti-spasmodics
    • Selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01615887

United States, New York
Kaleida Health, Jacobs Neurological Institute
Buffalo, New York, United States, 14203
Sponsors and Collaborators
State University of New York at Buffalo

Responsible Party: State University of New York at Buffalo Identifier: NCT01615887     History of Changes
Other Study ID Numbers: NEU2570309B
First Posted: June 11, 2012    Key Record Dates
Last Update Posted: June 11, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Multiple Sclerosis
Cognitive Dysfunction
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents