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This study has been withdrawn prior to enrollment.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)
Information provided by:
Hadassah Medical Organization Identifier:
First received: May 6, 2008
Last updated: June 2, 2010
Last verified: May 2008
The study aims to assess the safety and efficacy of nasale administration of Dexamethasone in relapsing MS patients

Condition Intervention Phase
MS Patient With Relpasing Remitting Attacks
Drug: Dexamethasone soduim phosphate
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nasal Administration of Dexamethasone for MS Treatment

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

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

Estimated Enrollment: 10
Study Start Date: July 2008
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00674141

Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Elka Touitou, PhD, Prof. Hebrew University, Jerusalem. Israel
  More Information

Responsible Party: Prof. Dminitrios Karussis, Hadassah Medical Organization Identifier: NCT00674141     History of Changes
Other Study ID Numbers: MS089-HMO-CTIL 
Study First Received: May 6, 2008
Last Updated: June 2, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Multiple Sclerosis, relapsing remitting, Dexamethasone

Additional relevant MeSH terms:
Multiple Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protease Inhibitors processed this record on May 23, 2016