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Central Nervous System Stimulant
Adderall XR for Cognitive Impairment in MS
Phase 2 & 3
Waitlist Available
Research Sponsored by Sarah Morrow
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
MS of any type as per 2010 McDonald's criteria
Males/females between the ages of 18-59, inclusive
Must not have
Uncontrolled or labile hypertension (> 135/85 mmHg), treated or untreated
History of structural heart disease, including atherosclerosis or angina
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
This trial will compare the effects of two doses of Adderall XR (a mixed amphetamine salt, extended release medication) to placebo on measures of processing speed and memory in people with MS.
Who is the study for?
This trial is for adults aged 18-59 with any type of Multiple Sclerosis, as per McDonald's criteria, who have cognitive impairment but are otherwise medically stable. Participants must not be pregnant or breastfeeding, should agree to use contraception, and cannot have certain psychiatric conditions or a history of substance abuse.
What is being tested?
The study tests the effectiveness of Adderall XR at doses of 10 mg and 20 mg compared to a placebo in improving processing speed and memory over 12 weeks. It also looks at self-reported cognition and quality of life in MS patients with cognitive issues.
What are the potential side effects?
Potential side effects from Adderall XR may include nervousness, restlessness, headache, dizziness, fearfulness or anxiety; less common side effects might be all types of heart problems like fast heartbeat or chest pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple sclerosis according to the 2010 criteria.
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I am between 18 and 59 years old.
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I can walk with assistance.
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I am not pregnant or breastfeeding.
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I can see well enough with both eyes to take tests, even if I need glasses.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My blood pressure is not stable and often above 135/85 mmHg.
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I have a history of heart disease, such as blocked arteries or chest pain.
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I have hyperthyroidism or glaucoma.
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I am allergic to amphetamines or Adderall XR.
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I have kidney problems or am taking medication that could harm my kidneys.
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My family has a history of sudden death or heart rhythm issues.
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I have been diagnosed with bipolar disorder or have had a psychotic episode.
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I use marijuana more than three times a week or fourteen times a month.
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I am currently taking amphetamine or similar medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Symbol Digit Modalities Test (SDMT)
Secondary study objectives
36-Item Short Form Survey
Brief Visuospatial Memory Test Revised - immediate recall
California Verbal Learning Test 2nd edition - immediate recall
+4 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: Adderall XR 20mgActive Control1 Intervention
20mg Adderall XR capsule to be taken orally once a day for 12 weeks.
Group II: Adderall XR 10mgActive Control1 Intervention
10mg Adderall XR capsule to be taken orally once a day for 12 weeks.
Group III: PlaceboPlacebo Group1 Intervention
Capsule with no active medical ingredients to be taken orally once a day for 12 weeks.
Find a Location
Who is running the clinical trial?
Sarah MorrowLead Sponsor
1 Previous Clinical Trials
26 Total Patients Enrolled
1 Trials studying Multiple Sclerosis
26 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood pressure is not stable and often above 135/85 mmHg.I have a history of heart disease, such as blocked arteries or chest pain.I have hyperthyroidism or glaucoma.My medications have been the same for the last 30 days and won't change during the study.I am between 18 and 59 years old.I haven't taken corticosteroids or had a relapse in the last 90 days.I can walk with assistance.I am not pregnant or breastfeeding.I have a medical condition like ADHD or Alzheimer's that could affect my thinking.I have been diagnosed with bipolar disorder or have had a psychotic episode.I use marijuana more than three times a week or fourteen times a month.I am not taking any drugs that could interfere with the study medication.I am allergic to amphetamines or Adderall XR.I have kidney problems or am taking medication that could harm my kidneys.My family has a history of sudden death or heart rhythm issues.I have been diagnosed with multiple sclerosis according to the 2010 criteria.I agree to use birth control during and after the trial unless I am unable to have children.I am currently taking amphetamine or similar medications.I can see well enough with both eyes to take tests, even if I need glasses.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Adderall XR 20mg
- Group 3: Adderall XR 10mg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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