Adderall XR and Processing Speed in Multiple Sclerosis (MS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by London Health Sciences Centre.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Sarah Morrow, London Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01667484
First received: August 13, 2012
Last updated: August 16, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Impaired Processing Speed
Cognitive Impairment
Multiple Sclerosis
Drug: Adderall XR 5mg
Drug: Adderall XR 10 mg
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Adderall XR Improve Processing Speed in Cognitively Impaired MS Patients?

Resource links provided by NLM:


Further study details as provided by London Health Sciences Centre:

Primary Outcome Measures:
  • Change in score of Paced Auditory Serial Addition Test (PASAT) [ Time Frame: pre and 7 hours post dose ] [ Designated as safety issue: No ]
    measure of processing speed

  • Change in Score of Symbol Digit Modalities Test (SDMT) [ Time Frame: pre and 7 hours post dose ] [ Designated as safety issue: No ]
    measure of processing speed


Secondary Outcome Measures:
  • Change in Score of Stroop Colour Word Test [ Time Frame: pre and 7 hours post dose ] [ Designated as safety issue: No ]
    Measure of Selective Attention

  • Blood Pressure [ Time Frame: 7 hours post dose ] [ Designated as safety issue: Yes ]
  • Heart Rate [ Time Frame: 7 hours post dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Active Comparator: Adderall XR 5mg
treatment group
Drug: Adderall XR 5mg
Active Comparator: Adderal XR 10mg
treatment group #2
Drug: Adderall XR 10 mg

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667484

Locations
Canada, Ontario
London Health Sciences Center and St. Joseph's Heathcare Center (Parkwood) Not yet recruiting
London, Ontario, Canada, N6G 1W8
Contact: Heather Rosehart, BScH    519 685 8500 ext 34706    heather.rosehart@lhsc.on.ca   
Sponsors and Collaborators
London Health Sciences Centre
Investigators
Principal Investigator: Sarah A Morrow, MD, MS, FRCPC London Health Sciences Center
  More Information

No publications provided

Responsible Party: Sarah Morrow, Assistant Professor of Neurology, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01667484     History of Changes
Other Study ID Numbers: 102774
Study First Received: August 13, 2012
Last Updated: August 16, 2012
Health Authority: Canada: Health Canada

Keywords provided by London Health Sciences Centre:
Cognitive Impairment
Multiple Sclerosis
Processing Speed
Treatment

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Cognition Disorders
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Adderall
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014