NCT00220493

Brief Summary

Scientific background: Growing awareness and accumulating data regarding the cognitive impairment and its progression in multiple sclerosis (MS) patients has received an important place in neurological research in the last decade.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

January 5, 2007

Status Verified

January 1, 2007

First QC Date

September 14, 2005

Last Update Submit

January 4, 2007

Conditions

Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Chronic Progressive

Keywords

MSRITALINPASATCOGNITIONATTENTIONRelapsing remittingSecondary progressivePrimary progressive

Outcome Measures

Primary Outcomes (1)

  • Score on the Paced Auditory Serial Addition Test (PASAT) one hour after taking the drug/placebo

Interventions

RitalinDRUG

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of definite MS according to Poser criteria;
  • Attention impairment defined as abnormal PASAT score;
  • Written and signed informed consent;

You may not qualify if:

  • Pregnancy or lactation;
  • Steroid treatment;
  • Persistent psychostimulant treatment;
  • MS relapse;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple Sclerosis Center

Ramat Gan, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis, Chronic Progressive

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Anat Achiron, MD PhD

    Sackler School of Medicine

    PRINCIPAL INVESTIGATOR

  • Yirmiyahu Harel, MD

    Sachler School of Medicine

    PRINCIPAL INVESTIGATOR

  • Nava Appleboim-Gavish, MA

    Sheba Medical Center at Tel Hashomer Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anat Achiron, MD PhD

CONTACT

972-3-5303932ACHIRON@POST.TAU.AC.IL

Nava Appleboim-Gavish, MA

CONTACT

972-3-5305309nava_a@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

June 1, 2003

Study Completion

June 1, 2005

Last Updated

January 5, 2007

Record last verified: 2007-01

Locations

IL(1)