Three Months Treatment With SB683699 In Patients With Rel... | NCT00097331

Studies
Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis

NCT00097331

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Apr 13, 2015Estimated

Enrollment

261Actual

Phase

Phase 2

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

SB683699

Countries

Belgium
Germany
Poland
Russia
Spain

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Jul 2006Actual

Completion Date

Jul 2006Actual

First Submitted Date

Nov 22, 2004

First Submission Date that Met QC Criteria

Nov 22, 2004

First Posted Date

Nov 23, 2004Estimated

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

Apr 10, 2015

Last Update Posted Date

Apr 13, 2015Estimated

Description Module

Brief Summary

The study will evaluate the effectiveness and safety of the investigational drug SB683699 in treating patients with relapsing multiple sclerosis (MS), using data from magnetic resonance imaging (MRI) scans as the main measure.

Detailed Description

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

261Actual

Name	Type	Description	Arm Group Labels	Other Names
SB683699	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of new gadolinium-enhancing lesions on monthly MRI scans

Secondary Outcomes

Measure	Description	Time Frame
Number of other lesion types on MRI
Number of relapses during treatment
Expanded Disability Status Scale (EDSS) and MS Functional Composite (MSFC)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Diagnosis of multiple sclerosis (MS).
Expanded Disability Status Score 0 - 6.5.
One or more relapse of MS in previous 12 months.
Currently not taking any medications for MS (apart from those used to treat symptoms).

Exclusion criteria:

Patients with significantly abnormal laboratory tests or electrocardiogram (ECG) results.
Subjects who cannot have MRI scans.
Women who are pregnant, breast feeding or planning to become pregnant during the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Brussels		1200	Belgium
GSK Investigational Site

Type	Date	Date Unknown
Release	Jul 12, 2017
Reset	Dec 4, 2017
Release	Dec 18, 2017
Unrelease	Aug 15, 2018

Submission Tracking

Estimated Results First Submitted Date

Jul 12, 2017

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 12, 2017			Dec 4, 2017
Dec 18, 2017	Aug 15, 2018

Condition Browse Module

MeSH Terms

ID	Term
D020529	Multiple Sclerosis, Relapsing-Remitting
D009103	Multiple Sclerosis
D012008	Recurrence

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

Intervention Browse Module

MeSH Terms

ID	Term
C585685	Firategrast

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided