Evaluation of Efficiency of Ritalin in Multiple Sclerosis (MS) Patients
Information source: Sheba Medical Center
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Relapsing Remitting Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive
Intervention: Ritalin (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Sheba Medical Center Official(s) and/or principal investigator(s):
Anat Achiron, MD PhD, Principal Investigator, Affiliation: Sackler School of Medicine
Yirmiyahu Harel, MD, Principal Investigator, Affiliation: Sachler School of Medicine
Nava Appleboim-Gavish, MA, Principal Investigator, Affiliation: Sheba Medical Center at Tel Hashomer Israel
Overall contact:
Anat Achiron, MD PhD, Phone: 972-3-5303932, Email: ACHIRON@POST.TAU.AC.IL
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.
Clinical Details
Official title: Clinical Study Protocol: Evaluation of the Efficiency of Ritalin in Multiple Sclerosis Patients
Study design: Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Score on the Paced Auditory Serial Addition Test (PASAT) one hour after taking the drug/placebo
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.
Eligibility
Minimum age: 25 Years.
Maximum age: 65 Years.
Gender(s): Both.
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;
Locations and Contacts
Anat Achiron, MD PhD, Phone: 972-3-5303932, Email: ACHIRON@POST.TAU.AC.IL
Multiple Sclerosis Center, Ramat Gan 52621, Israel; Recruiting
Anat Achiron, MD PhD, Principal Investigator
Additional Information
Starting date: June 2003
Ending date: June 2005
Last updated: January 4, 2007
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