Nasal Administration of Dexamethasone for Multiple Sclero... | NCT00674141

Studies
Nasal Administration of Dexamethasone for Multiple Sclerosis (MS) Treatment

NCT00674141

Sponsor

Hadassah Medical Organization

Status

Withdrawn

Last Update Posted

Jun 3, 2010Estimated

Enrollment

10Estimated

Phase

Phase 1

Conditions

MS Patient With Relpasing Remitting Attacks

Interventions

Dexamethasone soduim phosphate

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

was not approved by the ministry of health

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Dec 2008Estimated

Completion Date

Jan 2009Estimated

First Submitted Date

May 6, 2008

First Submission Date that Met QC Criteria

May 6, 2008

First Posted Date

May 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2010

Last Update Posted Date

Jun 3, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	only one experimental treated group	Drug: Dexamethasone soduim phosphate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone soduim phosphate	Drug	nasale administation of Dexamethasone in 20mg dose/day (in two divided doses) fpr sevem days of treatment	1

Measure	Description	Time Frame
reduction in the EDSS functional system score		four months

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elka Touitou, PhD, Prof.	Hebrew University, Jerusalem. Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem		91120	Israel

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided