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

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00220493
Enrollment
80
Registered
2005-09-22
Start date
2003-06-30
Completion date
2005-06-30
Last updated
2007-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Remitting Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive

Keywords

MS, RITALIN, PASAT, COGNITION, ATTENTION, Relapsing remitting, Secondary progressive, Primary progressive

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.

Interventions

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
ECT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No

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;

Design outcomes

Primary

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

Countries

Israel

Contacts

Primary ContactAnat Achiron, MD PhD
ACHIRON@POST.TAU.AC.IL972-3-5303932
Backup ContactNava Appleboim-Gavish, MA
nava_a@hotmail.com972-3-5305309

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026