Phase 2
Completed N=63
Study of Lisdexamfetamine Sulfate to Treat Cognitive Dysfunction in Multiple Sclerosis
Source: ClinicalTrials.gov NCT01615887 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcomePrimary: Symbol Digit Modalities Test (SDMT) — 36.9; 46.8 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symbol Digit Modalities Test (SDMT) |
36.9; 46.8 | — |
| PRIMARY Paced Auditory Serial Audition Test (PASAT) |
32.0; 37.4 | — |
| SECONDARY California Verbal Learning Test - 2nd Edition |
44.9; 49.2 | — |
| SECONDARY Brief Visuospatial Memory Test - Revised |
15.2; 18.7 | — |
| SECONDARY Vitals |
72.3; 76.9 | — |
| SECONDARY Vitals (Diastolic Blood Pressure) |
75.1; 77.7 | — |
| SECONDARY Vitals (Systolic Blood Pressure) |
127.3; 121.6 | — |
Eligibility Criteria
Inclusion Criteria
- Males/Females who are ≥ 18 years old and 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.
Data sourced from ClinicalTrials.gov (NCT01615887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.