Adderall XR and Processing Speed in Multiple Sclerosis (MS)

NCT ID: NCT01667484

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

treatment group #1

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Adderall XR 5mg

treatment group #2

Group Type: ACTIVE_COMPARATOR

Adderall XR 5mg

Intervention Type: DRUG

Adderal XR 10mg

treatment group #3

Group Type: ACTIVE_COMPARATOR

Adderall XR 10 mg

Intervention Type: DRUG

Interventions

Adderall XR 5mg

Intervention Type: DRUG

Adderall XR 10 mg

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Sarah Morrow

Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah A Morrow, MD, MS, FRCPC

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Center

Locations

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

London, Ontario, Canada

Countries

Canada

Other Identifiers

102774

Identifier Type: -

Identifier Source: org_study_id