Nasal Administration of Dexamethasone for Multiple Sclerosis (MS) Treatment

June 2, 2010 updated by: Hadassah Medical Organization

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
only one experimental treated group
Drug: Dexamethasone soduim phosphate
nasale administation of Dexamethasone in 20mg dose/day (in two divided doses) fpr sevem days of treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
reduction in the EDSS functional system score
Time Frame: four months
four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Elka Touitou, PhD, Prof., Hebrew University, Jerusalem. Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

January 1, 2009

Study Registration Dates

First Submitted

May 6, 2008

First Submitted That Met QC Criteria

May 6, 2008

First Posted (Estimate)

May 7, 2008

Study Record Updates

Last Update Posted (Estimate)

June 3, 2010

Last Update Submitted That Met QC Criteria

June 2, 2010

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS089-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe