Multiple SclerosisNCT00331747
Gait Evaluation in Multiple Sclerosis Patients Treated With Glatiramer Acetate
A study testing Glatiramer acetate in people with Multiple Sclerosis, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Hypothesis: Treatment with Glatiramer acetate prevents deterioration of gait in multiple sclerosis (MS) patients. During the study patients will undergo a 3 dimensional gait analysis before starting treatment with glatiramer acetate and after 1 year of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Glatiramer acetate
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- May 2006to not given
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of multiple sclerosis
- EDSS less than 5.5
- No cognitive disability
Who cannot join
- EDSS over 5.5
- Inability to cooperate with gait analysis
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Multiple Sclerosis Center, Sheba Medical Center
Tel HaShomer, 52621
Uri Givon, MD
About this study
Official title: Three Dimensional Gait Evaluation in Relapsing Remitting Multiple Sclerosis Patients Treated With Glatiramer Acetate
Hypothesis: Treatment with Glatiramer acetate prevents deterioration of gait in multiple sclerosis (MS) patients.
During the study patients will undergo a 3 dimensional gait analysis before starting treatment with glatiramer acetate and after 1 year of treatment.
Read the detailed description
Patients with a definite diagnosis of relapsing remitting multiple sclerosis (MS) will undergo a 3 dimensional gait analysis before initiation of treatment with glatiramer acetate. The gait analysis will include kinematic evaluation using a Charnwood Dynamics CODA CX-1 system, 4 AMTI force plates and a Noraxon telemetric EMG system. Patients will be videotaped and will also undergo a detailed physical examination by a physical therapist.
Treatment with Glatiramer acetate will be initiated after the gait analysis. Therapy will be observed and controlled by a neurologist fromn the staff of the Multiple Sclerosis Center.
Repeat gait analysis will be performed after one year of treatment.
- Conditions
- Multiple Sclerosis
- Being tested
- Glatiramer acetate
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glatiramer acetateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized gait analysis: at the beginning of treatment and after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2006 (estimated)
- Study startMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Uri Givon, MD, Principal investigator, Sheba Medical Center; Tel Aviv UniversityAnat Achiron, MD, PhD, Study chair, Sheba Medical Center; Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00331747
- Sponsor's protocol ID
- SHEBA-05-3985-UG-CTIL
- Status last verified
- Jul 2006
- First submitted
- 30 May 2006
- Last updated
- 7 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dimensional Gait Evaluation in Relapsing Remitting Multiple Sclerosis Patients Treated With Glatiramer Acetate
- ClinicalTrials.gov ID
- NCT00331747
- Acronym / sponsor ID
- SHEBA-05-3985-UG-CTIL
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- May 2006
- First posted
- 31 May 2006 (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.
Hypothesis: Treatment with Glatiramer acetate prevents deterioration of gait in multiple sclerosis (MS) patients.
During the study patients will undergo a 3 dimensional gait analysis before starting treatment with glatiramer acetate and after 1 year of treatment.
Detailed description
Patients with a definite diagnosis of relapsing remitting multiple sclerosis (MS) will undergo a 3 dimensional gait analysis before initiation of treatment with glatiramer acetate. The gait analysis will include kinematic evaluation using a Charnwood Dynamics CODA CX-1 system, 4 AMTI force plates and a Noraxon telemetric EMG system. Patients will be videotaped and will also undergo a detailed physical examination by a physical therapist.
Treatment with Glatiramer acetate will be initiated after the gait analysis. Therapy will be observed and controlled by a neurologist fromn the staff of the Multiple Sclerosis Center.
Repeat gait analysis will be performed after one year of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of multiple sclerosis
- EDSS less than 5.5
- No cognitive disability
Key exclusion criteria (2 listed)
- EDSS over 5.5
- Inability to cooperate with gait analysis
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 |
|---|---|---|
| Glatiramer acetate | Drug | – |
Primary outcome
Computerized gait analysis: at the beginning of treatment and after 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2006.
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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.
Uri Givon, MD principal investigator
Sheba Medical Center; Tel Aviv University
Anat Achiron, MD, PhD study chair
Sheba Medical Center; Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glatiramer acetate in people with Multiple Sclerosis, 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 2 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 7 Jul 2006. 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.
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 Uri Givon, MD (+972-35304451, urigi@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computerized gait analysis: at the beginning of treatment and after 1 year. 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 7 Jul 2006.