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

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00220493
• Other study ID #: SHEBA-03-2966-AA-CTIL
• Status: Recruiting
• Phase: Phase 1
• First received: September 14, 2005
• Last updated: January 4, 2007
• Start date: June 2003
• Est. completion date: June 2005

Study information

• Verified date: January 2007
• Source: Sheba Medical Center
• Contact: Anat Achiron, MD PhD
• Phone: 972-3-5303932
• Email: ACHIRON[@]POST.TAU.AC.IL
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Ritalin

Locations

Country	Name	City	State
Israel	Multiple Sclerosis Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on the Paced Auditory Serial Addition Test (PASAT) one hour after taking the drug/placebo