Nasal Administration of Dexamethasone for Multiple Sclerosis (MS) Treatment

This study has been withdrawn prior to enrollment.

(was not approved by the ministry of health)

Sponsor:

Information provided by:

Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT00674141

First received: May 6, 2008

Last updated: June 2, 2010

Last verified: May 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

May 6, 2008

Last Updated Date

June 2, 2010

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

reduction in the EDSS functional system score [ Time Frame: four months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00674141 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Nasal Administration of Dexamethasone for Multiple Sclerosis (MS) Treatment

Official Title ^ICMJE

Nasal Administration of Dexamethasone for MS Treatment

Brief Summary

The study aims to assess the safety and efficacy of nasale administration of Dexamethasone in relapsing MS patients

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

MS Patient With Relpasing Remitting Attacks

Intervention ^ICMJE

Drug: Dexamethasone soduim phosphate

nasale administation of Dexamethasone in 20mg dose/day (in two divided doses) fpr sevem days of treatment

Study Arm (s)

only one experimental treated group

Intervention: Drug: Dexamethasone soduim phosphate

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2009

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00674141

Other Study ID Numbers ^ICMJE

MS089-HMO-CTIL

Has Data Monitoring Committee

Responsible Party

Prof. Dminitrios Karussis, Hadassah Medical Organization

Study Sponsor ^ICMJE

Hadassah Medical Organization

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Elka Touitou, PhD, Prof.

Hebrew University, Jerusalem. Israel

Information Provided By

Hadassah Medical Organization

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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