Active — Not RecruitingPhase 2/3

Adderall XR and Cognitive Impairment in MS

Canada180 participantsStarted 2016-05-20

Plain-language summary

This 12 week randomized placebo-controlled study will compare the effects of 10 mg and 20 mg of a mixed amphetamine salt, extended release medication (trade name Adderall XR) to placebo on objective measures of processing speed and memory, as well as on self-reported measures of cognition and quality of life. To be enrolled in the study, MS subjects must demonstrate impaired processing speed on the Symbol Digit Modalities Test (SDMT).

Who can participate

Age range

18 Years – 59 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * MS of any type as per 2010 McDonald's criteria * Males/females between the ages of 18-59, inclusive * Have not received corticosteroids or experienced a relapse in the last ninety days * An Expanded Disability Status Scale (EDSS) of ≤ 7.0 * If female, must neither be pregnant nor breast-feeding (pregnancy test to be complete at enrollment for those of childbearing potential) * Willingness to use appropriate contraceptive measures (hormonal contraceptives (i.e., oral contraceptives, patch, vaginal ring, injectables or implants); intrauterine device or system; vasectomy or tubal ligation) both males and females at least 28 days before, for the duration of the trial and for at least 30 days after the study ends unless post-menopausal (no menses for 12 months) or surgically sterile female (complete hysterectomy, bilateral salpingectomy, or tubal ligation with documentation) or vasectomised male partner (with appropriate documentation of azoospermia). * Ability to complete the neuropsychological tests included in the battery including binocular visual acuity of ≤ 20/70 corrected or uncorrected * Stable medications for over the last 30 days with no planned change for the duration of the study. Exclusion Criteria: * Evidence of other medical potential cause(s) of cognitive deficits such ADHD, TBI, Alzheimer's disease or other dementia, stroke, previous chronic CNS infection or other neurological disorders * Evidence of untreated major depression as by clinic…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Symbol Digit Modalities Test (SDMT)

Timeframe: 12 weeks

Trial details

NCT IDNCT02676739

SponsorSarah Morrow

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11

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