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Relapsing Remitting Multiple SclerosisPhase 1NCT00220493

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

A Phase 1 study testing Ritalin in people with Relapsing Remitting Multiple Sclerosis and Multiple Sclerosis, Chronic Progressive, run by Sheba Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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. Read more about this study

Who is it for?
Ages 25 to 65 years
What is being tested?
Ritalin
How many people
80 participants
Where
1 siteIsrael
Study dates
Jun 2003to Jun 2005
Phase
Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of definite MS according to Poser criteria;
  • Attention impairment defined as abnormal PASAT score;
  • Written and signed informed consent;

Who cannot join

  • Pregnancy or lactation;
  • Steroid treatment;
  • Persistent psychostimulant treatment;
  • MS relapse;

Trial locations and contacts

1 site in 1 country.

Anat Achiron, MD PhD contact

972-3-5303932

ACHIRON@POST.TAU.AC.IL

Nava Appleboim-Gavish, MA contact

972-3-5305309

nava_a@hotmail.com

Israel1 site, 1 recruiting
  • Multiple Sclerosis Center

    Ramat Gan, 52621

    Anat Achiron, MD PhD

    Recruiting

Other trials in Israel

About this study

Official title: 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.

Read the 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.

Being tested
Ritalin
Keywords
MS, RITALIN, PASAT, COGNITION, ATTENTION, Relapsing remitting, Secondary progressive, Primary progressive
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RitalinDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Score on the Paced Auditory Serial Addition Test (PASAT) one hour after taking the drug/placebo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startJun 2003
  3. Study completionJun 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Early clinical test
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
80 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00220493
Sponsor's protocol ID
SHEBA-03-2966-AA-CTIL
Status last verified
Jan 2007
First submitted
14 Sep 2005
Last updated
5 Jan 2007
Results posted
No

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