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Clinical Trials/NCT00220493
NCT00220493
Unknown
Phase 1

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

Sheba Medical Center1 site in 1 country80 target enrollmentJune 2003

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Relapsing Remitting Multiple Sclerosis
Sponsor
Sheba Medical Center
Enrollment
80
Locations
1
Primary Endpoint
Score on the Paced Auditory Serial Addition Test (PASAT) one hour after taking the drug/placebo
Last Updated
19 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2003
End Date
June 2005
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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;

Outcomes

Primary Outcomes

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

Study Sites (1)

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