Evaluation of Efficiency of Ritalin in Multiple Sclerosis (MS) Patients
Primary Purpose
Relapsing Remitting Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive
Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Ritalin
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Relapsing Remitting Multiple Sclerosis focused on measuring MS, RITALIN, PASAT, COGNITION, ATTENTION, Relapsing remitting, Secondary progressive, Primary progressive
Eligibility Criteria
Inclusion Criteria: Diagnosis of definite MS according to Poser criteria; Attention impairment defined as abnormal PASAT score; Written and signed informed consent; Exclusion Criteria: Pregnancy or lactation; Steroid treatment; Persistent psychostimulant treatment; MS relapse;
Sites / Locations
- Multiple Sclerosis CenterRecruiting
Outcomes
Primary Outcome Measures
Score on the Paced Auditory Serial Addition Test (PASAT) one hour after taking the drug/placebo
Secondary Outcome Measures
Full Information
NCT ID
NCT00220493
First Posted
September 14, 2005
Last Updated
January 4, 2007
Sponsor
Sheba Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00220493
Brief Title
Evaluation of Efficiency of Ritalin in Multiple Sclerosis (MS) Patients
Official Title
Clinical Study Protocol: Evaluation of the Efficiency of Ritalin in Multiple Sclerosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
5. Study Description
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.
Detailed Description
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. Cognitive impairments occur frequently (43 to 65%) in MS. Moreover, in up to 50% of patients in whom no cognitive disturbances are found on routine neurological examination, cognitive impairments can be elicited using sensitive and disease specific neuropsychological tests. Even in patients with short disease duration of less than two years, discrete impairment of cognitive function may be found in up to 60% on neuropsychological testing without impacting activities of daily living.
We have recently reported that cognitive impairment occurred in 53.7% of patients with probable MS (evaluated within a mean of one month of the onset of new neurological symptoms). Verbal abilities and attention span were most frequently affected (43.3 and 41.8% respectively). An additional study demonstrated that MS patients within the first 5 years of disease onset presented attentional dysfunction only when the cognitive load of the attention task was high and when controlled information processing was required. This high rate of attention impairment found in MS patients early in the disease process may have a significant impact on quality of life and activities of daily living as attention is one of the most fundamental cognitive functions essential for normal daily activities and a requisite step towards conscious perception. Consequently, we suggest investigating whether treatment with Ritalin (methylphenidate) has an effect on patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive
Keywords
MS, RITALIN, PASAT, COGNITION, ATTENTION, Relapsing remitting, Secondary progressive, Primary progressive
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ritalin
Primary Outcome Measure Information:
Title
Score on the Paced Auditory Serial Addition Test (PASAT) one hour after taking the drug/placebo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of definite MS according to Poser criteria;
Attention impairment defined as abnormal PASAT score;
Written and signed informed consent;
Exclusion Criteria:
Pregnancy or lactation;
Steroid treatment;
Persistent psychostimulant treatment;
MS relapse;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anat Achiron, MD PhD
Phone
972-3-5303932
Email
ACHIRON@POST.TAU.AC.IL
First Name & Middle Initial & Last Name or Official Title & Degree
Nava Appleboim-Gavish, MA
Phone
972-3-5305309
Email
nava_a@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anat Achiron, MD PhD
Organizational Affiliation
Sackler School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yirmiyahu Harel, MD
Organizational Affiliation
Sachler School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nava Appleboim-Gavish, MA
Organizational Affiliation
Sheba Medical Center at Tel Hashomer Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Multiple Sclerosis Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anat Achiron, MD PhD
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Efficiency of Ritalin in Multiple Sclerosis (MS) Patients
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