Study of Lisdexamfetamine Sulfate to Treat Cognitive Dysfunction in Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT01615887
First received: March 23, 2011
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Multiple Sclerosis
Drug: lisdexamfetamine sulfate
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Lisdexamfetamine on Bradyphrenia in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:
  • Symbol Digit Modalities Test SDMT) and Paced Auditory Serial Addition Test [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Measures of Processing Speed


Secondary Outcome Measures:
  • California Verbal Learning Test - 2nd edition [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Measure of verbal memory

  • Brief Visuospatial Memory Test - Revised [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Visual memory test

  • vitals [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Heart rate and blood pressure


Enrollment: 63
Study Start Date: November 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615887

Locations
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
  More Information

No publications provided

Responsible Party: State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT01615887     History of Changes
Other Study ID Numbers: NEU2570309B
Study First Received: March 23, 2011
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014