NCT00300716

Brief Summary

This study is designed to determine whether memantine is an effective treatment for memory and cognitive problems associated with multiple sclerosis when compared to placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_2 multiple-sclerosis

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_2 multiple-sclerosis

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

4.8 years

First QC Date

March 8, 2006

Last Update Submit

October 10, 2019

Conditions

Multiple SclerosisCognition Disorders

Keywords

Multiple SclerosisCognitive impairmentMemantinePlaceboNeuropsychological testsQuality of lifeFatigue

Outcome Measures

Primary Outcomes (1)

  • Change in the Paced Auditory Serial Addition Test and the California Verbal Learning Test II (multivariate end-point) after 15 weeks of treatment.

Secondary Outcomes (11)

  • Controlled Oral Word Association Test

  • Stroop Color and Word Test

  • Symbol Digit Modalities Test

  • Delis-Kaplan Executive Function System

  • Perceived Deficit Questionnaire

  • +6 more secondary outcomes

Interventions

MemantineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diagnosis of multiple sclerosis as defined by the McDonald criteria. Patients with relapsing-remitting, secondary progressive, and primary progressive forms of MS are eligible.
  • Age between 18 and 65 years.
  • Demonstrated cognitive dysfunction at screening defined as a score worse than 1.0 standard deviations below the mean on the PASAT or the CVLT-II.

You may not qualify if:

  • A history of major depression, psychosis, or a score \> 19 on the Beck's Depression Inventory.
  • Corrected binocular visual acuity worse than 20/50; any impairment of binocular color vision.
  • Patients that do not speak English as a primary language (fluency may impact performance).
  • A clinically significant MS exacerbation within 30 days of the screening
  • Pregnancy
  • Renal insufficiency.
  • History of seizures.
  • Patients using acetazolamide (Diamox, Ak-sol, Storzolamide), dichlorphenamide (Daranide), methazolamide (Neptazane) or topiramate (Topamax), dextromethorphan (Robitussin DM and other cold remedies), or amantadine (Symmetrel).
  • Use of medical marijuana in the prior six months.
  • History of alcohol abuse or illicit drug use in the prior six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

USC

Los Angeles, California, 90033, United States

Location

OHSU

Portland, Oregon, 97201, United States

Location

UT Southwestern

Dallas, Texas, 75390-9036, United States

Location

MS Hub

Seattle, Washington, 98101, United States

Location

Related Publications (1)

  • Lovera JF, Frohman E, Brown TR, Bandari D, Nguyen L, Yadav V, Stuve O, Karman J, Bogardus K, Heimburger G, Cua L, Remingon G, Fowler J, Monahan T, Kilcup S, Courtney Y, McAleenan J, Butler K, Wild K, Whitham R, Bourdette D. Memantine for cognitive impairment in multiple sclerosis: a randomized placebo-controlled trial. Mult Scler. 2010 Jun;16(6):715-23. doi: 10.1177/1352458510367662. Epub 2010 May 18.

    PMID: 20483885DERIVED

Related Links

MeSH Terms

Conditions

Multiple SclerosisCognition DisordersCognitive DysfunctionFatigue

Interventions

Memantine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesNeurocognitive DisordersMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Dennis Bourdette, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

  • Lovera Jesus, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

  • Daniel Bandari, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

  • Ted Brown, MD

    MS Hub

    PRINCIPAL INVESTIGATOR

  • Elliot Frohman, MD

    UT Southwestern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2006

First Posted

March 9, 2006

Study Start

April 1, 2004

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

October 15, 2019

Record last verified: 2019-10

Locations

US(4)