Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline - Full Text View

Sponsored by:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00203112

Purpose

This study investigates the add-on effect of oral minocycline in subjects treated with daily injection of Copaxone. Copaxone and minocycline are thought to have differential modes of actions that may complement each other in treating MS symptoms.

Condition	Intervention	Phase
Relapse Remitting Multiple Sclerosis	Drug: glatiramer acetate Drug: minocycline	Phase II

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Minocycline Minocycline hydrochloride Copolymer 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Centered, Randomized, Double-Blind, Placebo-Controlled, Parallel Study Assessing the Add-on Effect of Minocycline in Relapsing-Remitting Multiple Sclerosis (RR-MS) Subjects Treated With Glatiramer Acetate (GA).

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

To evaluate the add-on treatment effect of oral minocycline in subjects treated with daily injection of GA as reflected by number of MRI T1 Gd-enhancing lesions in T1-weighted images.

Estimated Enrollment:	50
Study Start Date:	May 2004
Estimated Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinically definite MS as defined by Poser et al. (Ann. Neurol. 1983) with disease duration (from onset) of at least 6 months.
Subjects must have a relapsing-remitting disease course.
Subjects must have had at least 1 documented relapse within the last year prior to study entry.
Subjects must have at least 1 and not more than 15 gadolinium (Gd)-enhancing lesions on the screening MRI scan.
Subjects must be relapse-free and not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the screening visit.
Subjects may be male or female. Women of child- bearing potential must use a contraceptive method deemed reliable by the investigator.
Subjects must be between the ages of 18 and 50 years inclusive.
Subjects must be ambulatory, with a Kurtzke EDSS score of between 0 and 5.0 inclusive.
Subjects must be willing and able to give written informed consent prior to entering the study.

Exclusion Criteria:

Previous use of injectable glatiramer acetate.
Previous use of cladribine.
Previous use of immunosuppressive agents in the last 6 months.
Use of experimental or investigational drugs, including I.V. immunoglobulin and statins, within 6 months prior to study entry.
Use of interferon agents or minocycline within 4 months prior to the screening visit.
Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry.
Previous total body irradiation or total lymphoid irradiation (TLI).
Pregnancy or breast feeding.
Subjects who experience a relapse between the screening (month -1) and baseline (month 0) visits.
Significant medical or psychiatric condition that affects the subject's ability to give informed consent, or to complete the study, or any condition which the investigator feels may interfere with participation in the study (e.g. alcohol or drug abuse).
A known history of sensitivity to mannitol.
Contraindication to or known history of sensitivity to tetracyclines.
A known history of sensitivity to gadolinium.
Inability to successfully undergo MRI scanning.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203112

Locations

Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Northern Alberta Clinical Trial Research Center
Edmonton, Alberta, Canada, T6G 2C8
Canada, British Columbia
UBC Hospital MS Research
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Quebec
CHUM - Hôpital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

Study Director:

Jean Godin, MD

Teva Neuroscience Canada

More Information

Additional Information:

For more information on Multiple Sclerosis This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	GA 9014
Study First Received:	September 13, 2005
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00203112 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Minocycline
Autoimmune Diseases
Demyelinating Diseases
Immunologic Factors
Adjuvants, Immunologic
Sclerosis
Multiple Sclerosis, Relapsing-Remitting

Immunosuppressive Agents
Copolymer 1
Anti-Bacterial Agents
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Anti-Infective Agents
Minocycline
Autoimmune Diseases
Immunologic Factors
Demyelinating Diseases
Immune System Diseases
Physiological Effects of Drugs
Nervous System Diseases
Adjuvants, Immunologic
Sclerosis

Immunosuppressive Agents
Multiple Sclerosis, Relapsing-Remitting
Pharmacologic Actions
Copolymer 1
Anti-Bacterial Agents
Multiple Sclerosis
Pathologic Processes
Therapeutic Uses
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 07, 2009