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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00674141
Other study ID # MS089-HMO-CTIL
Secondary ID
Status Withdrawn
Phase Phase 1
First received May 6, 2008
Last updated June 2, 2010
Start date July 2008
Est. completion date January 2009

Study information

Verified date May 2008
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

The study aims to assess the safety and efficacy of nasale administration of Dexamethasone in relapsing MS patients


Recruitment information / eligibility

Status Withdrawn
Enrollment 10
Est. completion date January 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dexamethasone soduim phosphate
nasale administation of Dexamethasone in 20mg dose/day (in two divided doses) fpr sevem days of treatment

Locations

Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary reduction in the EDSS functional system score four months No