Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nasal Administration of Dexamethasone for Multiple Sclerosis (MS) Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00674141
Recruitment Status : Withdrawn (was not approved by the ministry of health)
First Posted : May 7, 2008
Last Update Posted : June 3, 2010
Sponsor:
Information provided by:
Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE May 6, 2008
First Posted Date  ICMJE May 7, 2008
Last Update Posted Date June 3, 2010
Study Start Date  ICMJE July 2008
Estimated Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2008)
reduction in the EDSS functional system score [ Time Frame: four months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE 1
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
 (submitted: May 6, 2008)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00674141
Other Study ID Numbers  ICMJE MS089-HMO-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account 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