Adderall XR and Processing Speed in Multiple Sclerosis (MS)

NCT01667484 | Completed Phase 2

• 1 other identifier: 102774
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Impaired Processing Speed; Cognitive Impairment; Multiple Sclerosis

Keywords

Cognitive Impairment; Multiple Sclerosis; Processing Speed; Treatment

Outcome Measures

Primary Outcomes (2)

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

  measure of processing speed

  pre and 7 hours post dose

• Change in Score of Symbol Digit Modalities Test (SDMT)

  measure of processing speed

  pre and 7 hours post dose

Study Arms (3)

Placebo

PLACEBO COMPARATOR

treatment group #1

Drug: Placebo

Adderall XR 5mg

ACTIVE COMPARATOR

treatment group #2

Drug: Adderall XR 5mg

Adderal XR 10mg

ACTIVE COMPARATOR

treatment group #3

Drug: Adderall XR 10 mg

Interventions

Adderall XR 5mg DRUG

Adderall XR 5mg

Adderall XR 10 mg DRUG

Adderal XR 10mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• London Health Sciences Centre: lead

Study Sites (1)

London Health Sciences Center and St. Joseph's Heathcare Center (Parkwood)

London, Ontario, N6G 1W8, Canada

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Multiple Sclerosis

Interventions

SLI381

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sarah A Morrow, MD, MS, FRCPC

  London Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: August 13, 2012
• First Posted: August 17, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2015
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

CA (1)