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Adderall XR and Processing Speed in Multiple Sclerosis (MS)

Information source: London Health Sciences Centre
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Impaired Processing Speed; Cognitive Impairment; Multiple Sclerosis

Intervention: Adderall XR 5mg (Drug); Adderall XR 10 mg (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: London Health Sciences Centre

Official(s) and/or principal investigator(s):
Sarah A Morrow, MD, MS, FRCPC, Principal Investigator, Affiliation: London Health Sciences Center

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.

Clinical Details

Official title: Does Adderall XR Improve Processing Speed in Cognitively Impaired MS Patients?

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Change in score of Paced Auditory Serial Addition Test (PASAT)

Change in Score of Symbol Digit Modalities Test (SDMT)

Eligibility

Minimum age: 18 Years. Maximum age: 59 Years. Gender(s): Both.

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

Locations and Contacts

London Health Sciences Center and St. Joseph's Heathcare Center (Parkwood), London, Ontario N6G 1W8, Canada
Additional Information

Starting date: September 2012
Last updated: May 7, 2015

Page last updated: August 20, 2015

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