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
- Are there results?
- None posted in the registry
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.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Protocol: Evaluation of the Efficiency of Ritalin in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT00220493
- Acronym / sponsor ID
- SHEBA-03-2966-AA-CTIL
- Keywords
- MS, RITALIN, PASAT, COGNITION, ATTENTION, Relapsing remitting, Secondary progressive, Primary progressive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jun 2003
- Study completion
- Jun 2005
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of definite MS according to Poser criteria;
- Attention impairment defined as abnormal PASAT score;
- Written and signed informed consent;
Key exclusion criteria (4 listed)
- Pregnancy or lactation;
- Steroid treatment;
- Persistent psychostimulant treatment;
- MS relapse;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ritalin | Drug | – |
Primary outcome
Score on the Paced Auditory Serial Addition Test (PASAT) one hour after taking the drug/placebo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anat Achiron, MD PhD principal investigator
Sackler School of Medicine
Yirmiyahu Harel, MD principal investigator
Sachler School of Medicine
Nava Appleboim-Gavish, MA principal investigator
Sheba Medical Center at Tel Hashomer Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anat Achiron, MD PhD (972-3-5303932, ACHIRON@POST.TAU.AC.IL), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the Paced Auditory Serial Addition Test (PASAT) one hour after taking the drug/placebo. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2007.