Back to resultsNasal Administration of Dexamethasone for Multiple Sclerosis (MS) Treatment
Primary Purpose
MS Patient With Relpasing Remitting Attacks
Status
Withdrawn
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Dexamethasone soduim phosphate
Sponsored by
About this trial
This is an interventional treatment trial for MS Patient With Relpasing Remitting Attacks focused on measuring Multiple Sclerosis, relapsing remitting, Dexamethasone
Eligibility Criteria
Inclusion Criteria:
- MS patients with esatblished relapsing remitting attacks
- increase in EDSS of at least 1 point for a least one day
Exclusion Criteria:
- children under 18
- pregnant patients
- patients with diabetes
- known allergy to steroids
- patients who received steroids within 3 months prior to the study
Sites / Locations
- Hadassah Medical Organization
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
only one experimental treated group
Outcomes
Primary Outcome Measures
reduction in the EDSS functional system score
Secondary Outcome Measures
Full Information
NCT ID
NCT00674141
First Posted
May 6, 2008
Last Updated
June 2, 2010
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00674141
Brief Title
Nasal Administration of Dexamethasone for Multiple Sclerosis (MS) Treatment
Official Title
Nasal Administration of Dexamethasone for MS Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Withdrawn
Why Stopped
was not approved by the ministry of health
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
January 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims to assess the safety and efficacy of nasale administration of Dexamethasone in relapsing MS patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MS Patient With Relpasing Remitting Attacks
Keywords
Multiple Sclerosis, relapsing remitting, Dexamethasone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
only one experimental treated group
Intervention Type
Drug
Intervention Name(s)
Dexamethasone soduim phosphate
Intervention Description
nasale administation of Dexamethasone in 20mg dose/day (in two divided doses) fpr sevem days of treatment
Primary Outcome Measure Information:
Title
reduction in the EDSS functional system score
Time Frame
four months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
MS patients with esatblished relapsing remitting attacks
increase in EDSS of at least 1 point for a least one day
Exclusion Criteria:
children under 18
pregnant patients
patients with diabetes
known allergy to steroids
patients who received steroids within 3 months prior to the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elka Touitou, PhD, Prof.
Organizational Affiliation
Hebrew University, Jerusalem. Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Nasal Administration of Dexamethasone for Multiple Sclerosis (MS) Treatment
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