Recall Enhancement Through Treatment With Atomoxetine in MS (RETAIN-MS
Phase Two Randomized Controlled Crossover Trial of Atomoxetine to Treat Memory Impairment Due to Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Atomoxetine
Placebo
- Placebo
Results by group
Change in Memory Change
baseline and 14 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Atomoxetine | 0.32 z-score | 0.6 (Standard Deviation) | 10 |
| Placebo | 0.24 z-score | 0.46 (Standard Deviation) | 10 |
Atomoxetine
Placebo
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Atomoxetine | 10 | 0 (0.0%) | 0 |
| Placebo | 10 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change in Memory Change
baseline and 14 weeks
Thinking and memory
Other measures (5)
Change in Patient-Reported Memory Change
baseline and 14 weeks
Thinking and memoryQuality of life (reported by participants)Change in CANTAB Paired Associate Learning
baseline and 14 weeks
Thinking and memoryChange in NIH Toolbox Picture Sequence Memory Test
baseline and 14 weeks
Thinking and memoryChange in Perceived Deficits Questionnaire (PDQ)
baseline and 14 weeks
Thinking and memoryChange in Symbol Digit Modalities Test
baseline and 14 weeks
Thinking and memory
Who could take part
MS (type not specified) · 21 to 60
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Mar 2017
Main results due
Jun 2018
Finished
Jun 2018
Results posted
Mar 2020