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.
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
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive
- 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.
Israel1 site, 1 recruiting
- Recruiting
Multiple Sclerosis Center
Ramat Gan, 52621
Anat Achiron, MD PhD
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.
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.
- First posted22 Sep 2005 (estimated)
- Study startJun 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Anat Achiron, MD PhD, Principal investigator, Sackler School of MedicineYirmiyahu Harel, MD, Principal investigator, Sachler School of MedicineNava Appleboim-Gavish, MA, Principal investigator, Sheba Medical Center at Tel Hashomer Israel
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