Adderall XR and Cognitive Impairment in MS

• Register: ClinicalTrials.gov
• Last refreshed on: 6 November 2023
• Main ID: NCT02676739
• Date of registration: 03/02/2016
• Prospective Registration: Yes
• Primary sponsor: Sarah Morrow
• Public title: Adderall XR and Cognitive Impairment in MS
• Scientific title: A Double-blind Placebo Controlled Study of Mixed-amphetamine Salts, Extended Release (Adderall XR) for Cognitive Impairment in MS
• Date of first enrolment: May 20, 2016
• Target sample size: 180
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02676739
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

Canada

Contacts

• Name: Sarah A Morrow, MD, MS, FRCPC

Key inclusion & exclusion criteria

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 clinician interview or patient report

- Family history of suicide, major depression, or bipolar disorder

- Uncontrolled or labile hypertension (> 135/85 mmHg), treated or untreated

- History of structural heart disease, including atherosclerosis or angina

- Diagnosis of bipolar disorder or a history of a psychotic episode

- Daily opioid use

- Daily benzodiazepine use other than nightly administration

- Use of other amphetamine or other sympathomimetic medication

- Use of naturally grown medicinal or non-medicinal marijuana more than 3x/week or
14x/month

- those with Hyperthyroidism or Glaucoma

- A history of drug abuse

- Known hypersensitivity to sympathomimetic amines

- A history of agitated or aggressive states

- Those taking monoamine oxidase inhibitors or other drugs that may interact with the
study medication

- A known allergy to amphetamines or components of Adderall XR or container

- Past or present suicidal behavior or ideation

- Those with renal impairment or on nephrotoxic drugs.

- Have motion tics (hard to control, repeat twitching of any parts of the body) or
verbal tics (hard to control repeating of sounds or words) or Tourette's syndrome

- Family history motion tics, verbal tics, or Tourette's syndrome

- Family history of sudden death, QT prolongation

- Positive pregnancy test

- Beck Depression Inventory - Fast Screen score question 7 marked 2 or 3 by participant,
or scores in the severe range



Age minimum: 18 Years
Age maximum: 59 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Adderall XR

Primary Outcome(s)

Symbol Digit Modalities Test (SDMT) [Time Frame: 12 weeks]

Secondary Outcome(s)

Brief Visuospatial Memory Test Revised - immediate recall [Time Frame: 12 weeks]

Perceived Deficits Questionnaire [Time Frame: 12 weeks]

The Modified Fatigue Impact Scale [Time Frame: 12 weeks]

Hospital Anxiety and Depression Scale [Time Frame: 12 weeks]

36-Item Short Form Survey [Time Frame: 12 weeks]

California Verbal Learning Test 2nd edition - immediate recall [Time Frame: 12 weeks]

Multiple Sclerosis Neuropsychological Screening Questionnaire [Time Frame: 12 weeks]

Secondary ID(s)

10012443

Source(s) of Monetary Support

Please refer to primary and secondary sponsors