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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00674141
First Posted: May 7, 2008
Last Update Posted: June 3, 2010
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.
Information provided by:
Hadassah Medical Organization
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Prof. Dminitrios Karussis, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00674141     History of Changes
Other Study ID Numbers: MS089-HMO-CTIL
First Submitted: May 6, 2008
First Posted: May 7, 2008
Last Update Posted: June 3, 2010
Last Verified: May 2008

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
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action