Adderall XR and Processing Speed in Multiple Sclerosis (MS)
Primary Purpose
Impaired Processing Speed, Cognitive Impairment, Multiple Sclerosis
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Adderall XR 5mg
Adderall XR 10 mg
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Impaired Processing Speed focused on measuring Cognitive Impairment, Multiple Sclerosis, Processing Speed, Treatment
Eligibility 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
- 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
Sites / Locations
- London Health Sciences Center and St. Joseph's Heathcare Center (Parkwood)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
Adderall XR 5mg
Adderal XR 10mg
Arm Description
treatment group #1
treatment group #2
treatment group #3
Outcomes
Primary Outcome Measures
Change in score of Paced Auditory Serial Addition Test (PASAT)
measure of processing speed
Change in Score of Symbol Digit Modalities Test (SDMT)
measure of processing speed
Secondary Outcome Measures
Full Information
NCT ID
NCT01667484
First Posted
August 13, 2012
Last Updated
May 7, 2015
Sponsor
London Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT01667484
Brief Title
Adderall XR and Processing Speed in Multiple Sclerosis (MS)
Official Title
Does Adderall XR Improve Processing Speed in Cognitively Impaired MS Patients?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
London Health Sciences Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Processing Speed, Cognitive Impairment, Multiple Sclerosis
Keywords
Cognitive Impairment, Multiple Sclerosis, Processing Speed, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
treatment group #1
Arm Title
Adderall XR 5mg
Arm Type
Active Comparator
Arm Description
treatment group #2
Arm Title
Adderal XR 10mg
Arm Type
Active Comparator
Arm Description
treatment group #3
Intervention Type
Drug
Intervention Name(s)
Adderall XR 5mg
Intervention Type
Drug
Intervention Name(s)
Adderall XR 10 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in score of Paced Auditory Serial Addition Test (PASAT)
Description
measure of processing speed
Time Frame
pre and 7 hours post dose
Title
Change in Score of Symbol Digit Modalities Test (SDMT)
Description
measure of processing speed
Time Frame
pre and 7 hours post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah A Morrow, MD, MS, FRCPC
Organizational Affiliation
London Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Center and St. Joseph's Heathcare Center (Parkwood)
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 1W8
Country
Canada
12. IPD Sharing Statement
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Adderall XR and Processing Speed in Multiple Sclerosis (MS)
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