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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00220493
First received: September 14, 2005
Last updated: January 4, 2007
Last verified: January 2007

September 14, 2005
January 4, 2007
June 2003
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Score on the Paced Auditory Serial Addition Test (PASAT) one hour after taking the drug/placebo
SCORE ON THE PASAT TEST ONE HOUR AFTER TAKING THE DRUG/PLACEBO.
Complete list of historical versions of study NCT00220493 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
  • Relapsing Remitting Multiple Sclerosis
  • Multiple Sclerosis, Chronic Progressive
Drug: Ritalin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
June 2005
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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;
Both
25 Years to 65 Years
No
Contact: Anat Achiron, MD PhD 972-3-5303932 ACHIRON@POST.TAU.AC.IL
Contact: Nava Appleboim-Gavish, MA 972-3-5305309 nava_a@hotmail.com
Israel
 
NCT00220493
SHEBA-03-2966-AA-CTIL
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Sheba Medical Center
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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
Sheba Medical Center
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP