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

Sponsor:	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 with minocycline Drug: Glatiramer acetate with placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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).

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Minocycline Minocycline hydrochloride Copolymer 1

U.S. FDA Resources

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. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of tolerability and safety [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment:	44
Study Start Date:	June 2004
Study Completion Date:	July 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Glatiramer Acetate injection with oral minocycline Glatiramer Acetate 20mg with oral minocycline 100mg	Drug: glatiramer acetate with minocycline Subcutaneous injection glatiramer acetate 20mg, with oral minocycline 100mg Other Name: Copaxone®
Experimental: Glatiramer Acetate with placebo Glatiramer acetate injection 20mg with oral placebo	Drug: Glatiramer acetate with placebo Subcutaneous injection glatiramer acetate 20mg, with oral placebo Other Name: Copaxone®

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

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

Publications:

Metz LM, Li D, Traboulsee A, Myles ML, Duquette P, Godin J, Constantin M, Yong VW; GA/minocycline study investigators. Glatiramer acetate in combination with minocycline in patients with relapsing--remitting multiple sclerosis: results of a Canadian, multicenter, double-blind, placebo-controlled trial. Mult Scler. 2009 Oct;15(10):1183-94. Epub 2009 Sep 23.

Responsible Party:	Jean-Louis Strill, MD, Teva Canada Innovation
ClinicalTrials.gov Identifier:	NCT00203112 History of Changes
Other Study ID Numbers:	GA 9014
Study First Received:	September 13, 2005
Last Updated:	April 11, 2011
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

Minocycline
Copolymer 1
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents

ClinicalTrials.gov processed this record on February 09, 2012