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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03091400
• Date of registration: 16/03/2017
• Prospective Registration: Yes
• Primary sponsor: Icahn School of Medicine at Mount Sinai
• Public title: Recall Enhancement Through Treatment With Atomoxetine in MS (RETAIN-MS)
• Scientific title: Phase Two Randomized Controlled Crossover Trial of Atomoxetine to Treat Memory Impairment Due to Multiple Sclerosis
• Date of first enrolment: March 16, 2017
• Target sample size: 11
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03091400
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: James F Sumowski, PhD
• Affiliation: Icahn School of Medicine at Mount Sinai

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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:

1. 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)

Exclusion Criteria:

- 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.



Age minimum: 21 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Memory Disorders

Intervention(s)

Drug: Placebo

Drug: Atomoxetine

Primary Outcome(s)

Change in Memory Change [Time Frame: baseline and 14 weeks]

Secondary Outcome(s)

Change in CANTAB Paired Associate Learning [Time Frame: baseline and 14 weeks]

Change in Patient-Reported Memory Change [Time Frame: baseline and 14 weeks]

Change in NIH Toolbox Picture Sequence Memory Test [Time Frame: baseline and 14 weeks]

Change in Symbol Digit Modalities Test [Time Frame: baseline and 14 weeks]

Change in Perceived Deficits Questionnaire (PDQ) [Time Frame: baseline and 14 weeks]

Secondary ID(s)

GCO 16-1552

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/03/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03091400