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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00220493
First Posted: September 22, 2005
Last Update Posted: January 5, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  Purpose

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.


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Drug: Ritalin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Educational/Counseling/Training
Official Title: Clinical Study Protocol: Evaluation of the Efficiency of Ritalin in Multiple Sclerosis Patients

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Score on the Paced Auditory Serial Addition Test (PASAT) one hour after taking the drug/placebo

Estimated Enrollment: 80
Study Start Date: June 2003
Estimated Study Completion Date: June 2005
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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220493


Contacts
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

Locations
Israel
Multiple Sclerosis Center Recruiting
Ramat Gan, Israel, 52621
Principal Investigator: Anat Achiron, MD PhD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
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
  More Information

ClinicalTrials.gov Identifier: NCT00220493     History of Changes
Other Study ID Numbers: SHEBA-03-2966-AA-CTIL
First Submitted: September 14, 2005
First Posted: September 22, 2005
Last Update Posted: January 5, 2007
Last Verified: January 2007

Keywords provided by Sheba Medical Center:
MS
RITALIN
PASAT
COGNITION
ATTENTION
Relapsing remitting
Secondary progressive
Primary progressive

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents