Impaired Processing SpeedPhase 2/3NCT01667484
Adderall XR and Processing Speed in Multiple Sclerosis (MS)
A Phase 2/3 study testing Adderall XR 5mg and Adderall XR 10 mg in people with Impaired Processing Speed and Cognitive Impairment, run by London Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Impaired Processing Speed, Cognitive Impairment, Multiple Sclerosis
- What is being tested?
- Adderall XR 5mg and Adderall XR 10 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Feb 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - 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
Who cannot join
- - 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Center and St. Joseph's Heathcare Center (Parkwood)
London, Ontario, N6G 1W8
About this study
Official title: 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.
- Being tested
- Adderall XR 5mg, Adderall XR 10 mg, Placebo
- Keywords
- Cognitive Impairment, Multiple Sclerosis, Processing Speed, Treatment
- Medical subject headings
- Cognitive Dysfunction, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adderall XR 5mgDrug
Adderall XR 10 mgDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | treatment group #1 Receives: Drug: Placebo |
| Adderall XR 5mg | Active comparator | treatment group #2 Receives: Drug: Adderall XR 5mg |
| Adderal XR 10mg | Active comparator | treatment group #3 Receives: Drug: Adderall XR 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score of Paced Auditory Serial Addition Test (PASAT)
measure of processing speed
Measured: pre and 7 hours post dose
Change in Score of Symbol Digit Modalities Test (SDMT)
measure of processing speed
Measured: pre and 7 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2013
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Processing SpeedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Morrow, London Health Sciences Centre
- Investigators
- Sarah A Morrow, MD, MS, FRCPC, Principal investigator, London Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667484
- Sponsor's protocol ID
- 102774
- Status last verified
- May 2015
- First submitted
- 13 Aug 2012
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Adderall XR Improve Processing Speed in Cognitively Impaired MS Patients?
- ClinicalTrials.gov ID
- NCT01667484
- Acronym / sponsor ID
- 102774
- Keywords
- Cognitive Impairment, Multiple Sclerosis, Processing Speed, Treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- London Health Sciences CentreUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 17 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebotreatment group #1 |
| Adderall XR 5mg | Active comparator | Drug: Adderall XR 5mgtreatment group #2 |
| Adderal XR 10mg | Active comparator | Drug: Adderall XR 10 mgtreatment group #3 |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- - 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
Key exclusion criteria (19 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adderall XR 5mg | Drug | Adderall XR 5mg |
| Adderall XR 10 mg | Drug | Adderal XR 10mg |
| Placebo | Drug | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah A Morrow, MD, MS, FRCPC principal investigator
London Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Adderall XR 5mg and Adderall XR 10 mg in people with Impaired Processing Speed and Cognitive Impairment, run by London Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in score of Paced Auditory Serial Addition Test (PASAT) (time frame: pre and 7 hours post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015; AzTrials last refreshed its copy on 27 Oct 2026.