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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This study has been withdrawn prior to enrollment.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
  Purpose

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:

U.S. FDA Resources

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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00674141

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

No publications provided

Responsible Party: Prof. Dminitrios Karussis, Hadassah Medical Organization
ClinicalTrials.gov 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
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013