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

NCT03091400 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: GCO 16-1552
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Memory Disorders; Multiple Sclerosis

Keywords

Memory Disorders; Multiple Sclerosis; Atomoxetine Hydrochloride

Outcome Measures

Primary Outcomes (1)

• Change in Memory Change

  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). Results reported as composite memory at follow-up minus baseline. Higher scores indicate better outcomes.

  baseline and 14 weeks

Secondary Outcomes (5)

• Change in Patient-Reported Memory Change

  baseline and 14 weeks

• Change in CANTAB Paired Associate Learning

  baseline and 14 weeks

• Change in NIH Toolbox Picture Sequence Memory Test

  baseline and 14 weeks

• Change in Perceived Deficits Questionnaire (PDQ)

  baseline and 14 weeks

• Change in Symbol Digit Modalities Test

  baseline and 14 weeks

Study Arms (2)

Atomoxetine

EXPERIMENTAL

Atomoxetine (40 mg qd titration dose for first seven days, followed by 80 mg qd target dose for remaining five weeks)

Drug: Atomoxetine

Placebo

PLACEBO COMPARATOR

Identically encapsulated placebo, with dose matched to experimental agent (40 mg qd titration dose for first seven days, followed by 80 mg qd target dose for remaining five weeks)

Drug: Placebo

Interventions

Atomoxetine DRUG

Atomoxetine (40 mg qd titration dose for first seven days, followed by 80 mg qd target dose for remaining five weeks)

Also known as: Strattera (Eli Lilly)

Atomoxetine

Placebo DRUG

Identically encapsulated placebo, with dose matched to experimental agent (40 mg qd titration dose for first seven days, followed by 80 mg qd target dose for remaining five weeks)

Placebo

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Memory Disorders; Multiple Sclerosis

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: James F Sumowski, PhD
• Organization: Icahn School of Medicine at Mount Sinai

james.sumowski@mssm.edu

212-241-6854

Study Officials

• James F Sumowski, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoicate Professor

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 27, 2017
• Study Start: March 16, 2017
• Primary Completion: June 11, 2018
• Study Completion: June 11, 2018
• Last Updated: March 13, 2020
• Results First Posted: March 13, 2020

Record last verified: 2020-02

Locations

US (1)