Adderall XR and Cognitive Impairment in MS

NCT02676739 | Active Not Recruiting Phase 2

• 1 other identifier: 10012443
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Symbol Digit Modalities Test (SDMT)

  This task will be performed at enrollment (and baseline if enrollment occurred great than 7 days prior), week 6 and week 12 after starting the medication. The SDMT is one of the most commonly used tests to assess processing speed in the MS population and is included in the two validated neuropsychological test batteries routinely used in MS studies, the Minimal Assessment of Cognitive Function in MS (MACFIMS).

  12 weeks

Secondary Outcomes (7)

• Brief Visuospatial Memory Test Revised - immediate recall

  12 weeks

• California Verbal Learning Test 2nd edition - immediate recall

  12 weeks

• Multiple Sclerosis Neuropsychological Screening Questionnaire

  12 weeks

• Perceived Deficits Questionnaire

  12 weeks

• 36-Item Short Form Survey

  12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Capsule with no active medical ingredients to be taken orally once a day for 12 weeks.

Drug: Adderall XR

Adderall XR 10mg

ACTIVE COMPARATOR

10mg Adderall XR capsule to be taken orally once a day for 12 weeks.

Drug: Adderall XR

Adderall XR 20mg

ACTIVE COMPARATOR

20mg Adderall XR capsule to be taken orally once a day for 12 weeks.

Drug: Adderall XR

Interventions

Adderall XR DRUG

Adderall XR 10mg; Adderall XR 20mg; Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sarah Morrow: lead

Study Sites (3)

Kaye Edmonton Clinic

Edmonton, Alberta, T6G 2G3, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• Morrow SA, Rosehart H. Effects of single dose mixed amphetamine salts--extended release on processing speed in multiple sclerosis: a double blind placebo controlled study. Psychopharmacology (Berl). 2015 Dec;232(23):4253-9. doi: 10.1007/s00213-015-4051-6. Epub 2015 Aug 21.

  PMID: 26289355 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

SLI381

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 8, 2016
• Study Start: May 20, 2016
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

CA (3)