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Completed

NCT Number: NCT01667484

Adderall XR and Processing Speed in Multiple Sclerosis (MS)

Cognitive impairment, or problems with thinking and memory, is common in multiple sclerosis (MS) and can occur independently of physical disability. It is the most common reason, along with physical fatigue, for MS patients to stop working. The most frequent complaint is problems with multi-tasking or thinking quickly, which corresponds to impairment in the cognitive domain of processing speed. Currently there is treatment available to prevent relapses and physical disability but there are no medications that have been shown to treat cognitive impairment. Amphetamines have been beneficial for selective attention and processing speed in attention deficit hyperactivity disorder (ADHD) and traumatic brain injury. This is study will determine whether Adderall XR improves objective measures of processing speed and attention in MS patients impaired in this cognitive domain, by comparing two doses of Adderall XR (5 and 10mg) to placebo before and after the medication is administered. The results of this study will help provide data to design a larger study to determine if Adderall XR, and potentially other amphetamine drugs, will help treat cognitive impairment in MS patients.

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

London Health Sciences Center and St. Joseph's Heathcare Center (Parkwood)

London, Ontario, N6G 1W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - Males/Females who are ≥ 18 years old and ≤ 59 years old
  • Relapsing Remitting, Secondary Progressive or Primary Progressive MS, as per revised McDonald's Criteria
  • Have not received corticosteroids in last thirty days or a relapse in the last ninety days
  • An Expanded Disability Status Scale (EDSS) of ≤ 6.5
  • If female, must neither be pregnant nor breast-feeding

Exclusion criteria

  • - Have evidence of other medical cause(s) of cognitive impairment
  • Have evidence of major depression as determined by a positive Beck Depression Index-Fast screen ≥ 13and/or by clinician interview or evidence of severe fatigue with a Fatigue Severity Scale ≥ 5.
  • Have demonstrated a hypersensitivity to amphetamines in the past
  • Have uncontrolled or labile hypertension (> 135/85 mm Hg, treated or untreated)
  • Have a history of structural heart disease, including atherosclerosis or angina
  • Have a diagnosis of bipolar disorder or a history of a psychotic episode
  • The following medications are not permitted to be used within 14 days the study
  • Monoamine Oxidase Inhibitors
  • Sympathomimetics or methadone
  • Antipsychotic agents
  • Modafinil
  • The following medications are permitted if the dose has been stable for ≥ 28 days
  • Short acting benzodiazepines, qhs administration only
  • Anticonvulsants, including gabapentin and pregabalin
  • Bupropion
  • Tricyclic Antidepressants
  • Anti-spasmodics such as baclofen or tizanidine
  • Anticholinergic medication
  • Selective serotonin(-norepinephrine) reuptake inhibitors

Treatment and study plan

Adderall XR 5mg

Drug

Adderall XR 10 mg

Drug

Placebo

Drug

Primary outcomes

  1. Change in score of Paced Auditory Serial Addition Test (PASAT)

    Time frame: pre and 7 hours post dose

    measure of processing speed

  2. Change in Score of Symbol Digit Modalities Test (SDMT)

    Time frame: pre and 7 hours post dose

    measure of processing speed

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre

Other

Registry information

Official study title

Does Adderall XR Improve Processing Speed in Cognitively Impaired MS Patients?

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Aug 17, 2012
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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