Recall Enhancement Through Treatment With Atomoxetine in MS (RETAIN-MS)

Completed · Phase 2 · Has a placebo group

Conditions studied: Memory Disorders, Multiple Sclerosis

In brief

The purpose of this crossover trial is to investigate whether atomoxetine (versus placebo) improves memory function in persons with memory deficits due to multiple sclerosis.

Key facts

Study ID

NCT03091400

Run by

Icahn School of Medicine at Mount Sinai

People needed

11

Starts

2017-03-16

Expected to finish

2018-06-11

Last updated by the study team

2020-03-13

Who can join

Age: 21 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Multiple Sclerosis based on the Revised McDonald criteria
• Age 21 - 60 years.
• Patient self-report of memory decline from previously higher level of functioning.
• Memory Impairment on validated neuropsychological memory screening tests, as follows:
• performance ≤16th percentile on both (i) Rey Auditory Verbal Learning Test (RAVLT) Total Learning (TL) and (ii) WMS-IV Visual Reproduction I (VR-I); and b) mean normative memory performance (RAVLT TL and WMS-IV VR-I) is at least 1.0 standard deviation below expectations based on the Wechsler Test of Adult Reading (WTAR)

You may not qualify if…

• Current stimulant medication usage.
• Previous diagnosis or treatment for ADHD or any neurologic condition other than multiple sclerosis (e.g., traumatic brain injury, epilepsy)
• Clinical relapse of MS within 60 days of screening,
• Change in disease-modifying therapy within 90 days of screening,
• Below average estimated premorbid intelligence (WTAR, < 16th percentile),
• Severe cognitive impairment indicated by a Mini-Mental Status Examination (MMSE) < 24/30.
• Contraindications for atomoxetine use: (a) self-reported history of suicidal ideation within the last twelve months (Columbia Suicide Severity Rating Scale), (b) diagnosis of bipolar illness, (c) moderate or severe current depressive symptomatology (Beck Depression Inventory Fast Screen ≥ 9), (d) diagnosis of hepatic disease, (e) narrow angle glaucoma, (f) pheochromocytoma, (g) monoamine oxidase inhibitor within 14 days of study drug start, (h) taking strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine), (i) diagnosis of heart disease, (j) pregnant or planning pregnancy during the study period, (k) breastfeeding, (l) hypersensitivity to atomoxetine or component of formulation.

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.