Nasal Administration of Dexamethasone for Multiple Sclerosis (MS) Treatment

This study is not yet open for participant recruitment.

Verified by Hadassah Medical Organization, May 2008

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00674141

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 I

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Nasal Administration of Dexamethasone for MS Treatment

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

Responsible Party:	Hadassah Medical Organization ( Prof. Dminitrios Karussis )
Study ID Numbers:	MS089-HMO-CTIL
Study First Received:	May 6, 2008
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00674141
Health Authority:	Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:

Multiple Sclerosis, relapsing remitting, Dexamethasone

Study placed in the following topic categories:

Dexamethasone
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Dexamethasone acetate
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Nervous System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists

Antiemetics
Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009