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Adderall XR and Processing Speed in Multiple Sclerosis (MS)

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ClinicalTrials.gov Identifier: NCT01667484
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Sarah Morrow, London Health Sciences Centre

August 13, 2012
August 17, 2012
May 12, 2015
September 2012
February 2013   (Final data collection date for primary outcome measure)
  • Change in score of Paced Auditory Serial Addition Test (PASAT) [ Time Frame: pre and 7 hours post dose ]
    measure of processing speed
  • Change in Score of Symbol Digit Modalities Test (SDMT) [ Time Frame: pre and 7 hours post dose ]
    measure of processing speed
Same as current
Complete list of historical versions of study NCT01667484 on ClinicalTrials.gov Archive Site
Not Provided
  • Change in Score of Stroop Colour Word Test [ Time Frame: pre and 7 hours post dose ]
    Measure of Selective Attention
  • Blood Pressure [ Time Frame: 7 hours post dose ]
  • Heart Rate [ Time Frame: 7 hours post dose ]
Not Provided
Not Provided
 
Adderall XR and Processing Speed in Multiple Sclerosis (MS)
Does Adderall XR Improve Processing Speed in Cognitively Impaired MS Patients?
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Impaired Processing Speed
  • Cognitive Impairment
  • Multiple Sclerosis
  • Drug: Adderall XR 5mg
  • Drug: Adderall XR 10 mg
  • Drug: Placebo
  • Placebo Comparator: Placebo
    treatment group #1
    Intervention: Drug: Placebo
  • Active Comparator: Adderall XR 5mg
    treatment group #2
    Intervention: Drug: Adderall XR 5mg
  • Active Comparator: Adderal XR 10mg
    treatment group #3
    Intervention: Drug: Adderall XR 10 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
60
February 2015
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 59 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01667484
102774
No
Not Provided
Not Provided
Sarah Morrow, London Health Sciences Centre
London Health Sciences Centre
Not Provided
Principal Investigator: Sarah A Morrow, MD, MS, FRCPC London Health Sciences Center
London Health Sciences Centre
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP