Evaluation of Efficiency of Ritalin in Multiple Sclerosis (MS) Patients

Sponsor

Sheba Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00220493

Collaborator

(none)

Enrollment

Location

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Scientific background:

Condition or Disease	Intervention/Treatment	Phase
Relapsing Remitting Multiple Sclerosis Multiple Sclerosis, Chronic Progressive	Drug: Ritalin	Phase 1

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Educational/Counseling/Training

Official Title:

Clinical Study Protocol: Evaluation of the Efficiency of Ritalin in Multiple Sclerosis Patients

Study Start Date :

Jun 1, 2003

Study Completion Date :

Jun 1, 2005

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Multiple Sclerosis Center	Ramat Gan		Israel	52621

Sponsors and Collaborators

Sheba Medical Center

Investigators

Principal Investigator: 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