MS Patient With Relpasing Remitting AttacksPhase 1NCT00674141
Nasal Administration of Dexamethasone for Multiple Sclerosis (MS) Treatment
A Phase 1 study testing Dexamethasone soduim phosphate in people with MS Patient With Relpasing Remitting Attacks, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The study aims to assess the safety and efficacy of nasale administration of Dexamethasone in relapsing MS patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MS Patient With Relpasing Remitting Attacks
- What is being tested?
- Dexamethasone soduim phosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2008to Jan 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MS patients with esatblished relapsing remitting attacks
- increase in EDSS of at least 1 point for a least one day
Who cannot join
- children under 18
- pregnant patients
- patients with diabetes
- known allergy to steroids
- patients who received steroids within 3 months prior to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nasal Administration of Dexamethasone for MS Treatment
The study aims to assess the safety and efficacy of nasale administration of Dexamethasone in relapsing MS patients
- Being tested
- Dexamethasone soduim phosphate
- Keywords
- Multiple Sclerosis, relapsing remitting, Dexamethasone
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone soduim phosphateDrug
nasale administation of Dexamethasone in 20mg dose/day (in two divided doses) fpr sevem days of treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | only one experimental treated group Receives: Drug: Dexamethasone soduim phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in the EDSS functional system score
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2008 (estimated)
- Study completionJan 2009 (estimated)
Why it stopped: was not approved by the ministry of health
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MS Patient With Relpasing Remitting AttacksStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Elka Touitou, PhD, Prof., Principal investigator, Hebrew University, Jerusalem. Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674141
- Sponsor's protocol ID
- MS089-HMO-CTIL
- Status last verified
- May 2008
- First submitted
- 6 May 2008
- Last updated
- 3 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Administration of Dexamethasone for MS Treatment
- ClinicalTrials.gov ID
- NCT00674141
- Acronym / sponsor ID
- MS089-HMO-CTIL
- Keywords
- Multiple Sclerosis, relapsing remitting, Dexamethasone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: was not approved by the ministry of health
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 7 May 2008 (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.
The study aims to assess the safety and efficacy of nasale administration of Dexamethasone in relapsing MS patients
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Dexamethasone soduim phosphateonly one experimental treated group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- MS patients with esatblished relapsing remitting attacks
- increase in EDSS of at least 1 point for a least one day
Key exclusion criteria (5 listed)
- children under 18
- pregnant patients
- patients with diabetes
- known allergy to steroids
- patients who received steroids within 3 months prior to the study
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 |
|---|---|---|
| Dexamethasone soduim phosphatenasale administation of Dexamethasone in 20mg dose/day (in two divided doses) fpr sevem days of treatment | Drug | 1 |
Primary outcome
reduction in the EDSS functional system score
Time frame: four months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2010.
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.
Elka Touitou, PhD, Prof. principal investigator
Hebrew University, Jerusalem. 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 Dexamethasone soduim phosphate in people with MS Patient With Relpasing Remitting Attacks, run by Hadassah Medical Organization 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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 3 Jun 2010. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in the EDSS functional system score (time frame: four months). 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 3 Jun 2010.