Evaluation of Efficiency of Ritalin in Multiple Sclerosis (MS) Patients
Recruitment status was Recruiting
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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 |
- 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 |
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 |
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| 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 | |
| Multiple Sclerosis Center | Recruiting |
| Ramat Gan, Israel, 52621 | |
| Principal Investigator: Anat Achiron, MD PhD | |
| 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 Sclerosis Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Relapsing-Remitting 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 May 23, 2013