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Adderall XR and Processing Speed in Multiple Sclerosis (MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01667484
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : May 12, 2015
Information provided by (Responsible Party):
Sarah Morrow, London Health Sciences Centre

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Impaired Processing Speed Cognitive Impairment Multiple Sclerosis Drug: Adderall XR 5mg Drug: Adderall XR 10 mg Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Adderall XR Improve Processing Speed in Cognitively Impaired MS Patients?
Study Start Date : September 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
treatment group #1
Drug: Placebo
Active Comparator: Adderall XR 5mg
treatment group #2
Drug: Adderall XR 5mg
Active Comparator: Adderal XR 10mg
treatment group #3
Drug: Adderall XR 10 mg

Primary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

    1. Monoamine Oxidase Inhibitors
    2. Sympathomimetics or methadone
    3. Antipsychotic agents
    4. Modafinil
  • The following medications are permitted if the dose has been stable for ≥ 28 days

    1. Short acting benzodiazepines, qhs administration only
    2. Anticonvulsants, including gabapentin and pregabalin
    3. Bupropion
    4. Tricyclic Antidepressants
    5. Anti-spasmodics such as baclofen or tizanidine
    6. Anticholinergic medication
    7. Selective serotonin(-norepinephrine) reuptake inhibitors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01667484

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Canada, Ontario
London Health Sciences Center and St. Joseph's Heathcare Center (Parkwood)
London, Ontario, Canada, N6G 1W8
Sponsors and Collaborators
London Health Sciences Centre
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Principal Investigator: Sarah A Morrow, MD, MS, FRCPC London Health Sciences Center
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Responsible Party: Sarah Morrow, Assistant Professor of Neurology, London Health Sciences Centre Identifier: NCT01667484    
Other Study ID Numbers: 102774
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Keywords provided by Sarah Morrow, London Health Sciences Centre:
Cognitive Impairment
Multiple Sclerosis
Processing Speed
Additional relevant MeSH terms:
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Multiple Sclerosis
Cognitive Dysfunction
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs