NCT03091400

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

Completed Phase 2 Results posted Last updated 13 March 2020

What this trial tests

Phase 2 trial testing Atomoxetine in Memory Disorders in 11 participants. Completed in 11 June 2018.

Timeline

16 March 2017

Primary endpoint
11 June 2018

11 June 2018

Quick facts

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	11
Start date	16 March 2017
Primary completion	11 June 2018
Estimated completion	11 June 2018
Sites	1 location across United States

Drugs / interventions tested

• Atomoxetine (ATOMOXETINE) — full drug profile →
• Placebo

Conditions studied

• Memory Disorders — all drugs for Memory Disorders →
• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

Adults 21 to 60, any sex, with Memory Disorders or Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Memory Change Primary · baseline and 14 weeks

Composite memory function (mean normative z-score) across verbal memory and visuospatial memory tasks: (1) Selective Reminding Test (SRT) assesses verbal learning of a 12-item word list over six trials (a. Total Learning; possible raw score range of 0-72), and recall after a delay (b: Delayed Recall; possible raw score range of 0-36); (2) Brief Visuospatial Memory Test, Revised (BVMT-R; possible raw score range of 0-36) assesses learning of six geometric shapes in six locations over three trials (c. Total Learning), and recall after a delay (d. Delayed Recall; possible raw score range of 0-12)

Group	Value	95% CI
Atomoxetine	0.32	± 0.60
Placebo	0.24	± 0.46

Change in Patient-Reported Memory Change Secondary · baseline and 14 weeks

Patients will endorse memory change over the past six weeks as: much improved (3), improved (2), slightly improved (1), unchanged (0), slightly worse (-1), worse (-2), much worse (-3).

Group	Value	95% CI
Atomoxetine	0.70	± 1.16
Placebo	0.90	± 1.37

Change in CANTAB Paired Associate Learning Secondary · baseline and 14 weeks

CANTAB Paired Associate Learning (Total Errors Adjusted; possible raw score range of 0-70): a tablet-based memory task requiring subjects to study and recall the location of complex visual images not easily verbalized. Errors are tallied. Results reported as follow-up minus baseline. Higher scores indicate worse outcomes.

Group	Value	95% CI
Atomoxetine	-10.30	± 11.98
Placebo	-8.10	± 15.56

Change in NIH Toolbox Picture Sequence Memory Test Secondary · baseline and 14 weeks

NIH Toolbox Picture Sequence Memory Test (possible raw score range of 0-31): a tablet-based task requiring subjects to study the sequence of many activity scenes (e.g., flying a kite) presented visually and audibly. Correct sequences tallied. Results reported as follow-up minus baseline. Higher scores indicate better outcomes.

Group	Value	95% CI
Atomoxetine	4.50	± 5.80
Placebo	3.20	± 2.97

Change in Perceived Deficits Questionnaire (PDQ) Secondary · baseline and 14 weeks

Perceived Deficits Questionnaire (PDQ): the PDQ asks subjects to rate twenty cognitive difficulties on a scale from never (0) to almost always (4). Total ranges from 0-80. Results reported as follow-up minus baseline. Higher scores indicate worse outcomes. If a change is detected, will proceed to identify which of the four subscales were affected: retrospective memory, prospective memory, attention, planning / organization.

Group	Value	95% CI
Atomoxetine	-6.60	± 9.97
Placebo	-5.90	± 13.14

Change in Symbol Digit Modalities Test Secondary · baseline and 14 weeks

Symbol Digit Modalities Test (Oral Version, total raw; possible range of 0-110): A test of processing speed requiring subjects to rapidly complete symbol-digit pairings based on a key. Incidental learning may contribute to performance. Total correct in 90 seconds is tallied. Results reported as follow-up minus baseline. Higher scores indicate better outcomes.

Group	Value	95% CI
Atomoxetine	7.20	± 7.07
Placebo	5.50	± 5.42

Adverse events — posted to ClinicalTrials.gov

Time frame: 14 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Atomoxetine

Serious: 0/10 (0%)

Deaths: 0/10

Placebo

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (7 terms — click to expand)

Reaction	System	Atomoxetine	Placebo
Diarrhea	Gastrointestinal disorders	—	—
Dizziness	Nervous system disorders	—	—
Abnormal dreams	Psychiatric disorders	—	—
Fatigue	General disorders	—	—
Urinary Hesitation	Renal and urinary disorders	—	—
Pelvic/testicular pain	Reproductive system and breast disorders	—	—
Painful Urination	Renal and urinary disorders	—	—

Data from ClinicalTrials.gov NCT03091400 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.