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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00220493     History of Changes
Other Study ID Numbers: SHEBA-03-2966-AA-CTIL
Study First Received: September 14, 2005
Last Updated: January 4, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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, Chronic Progressive
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014