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Glatiramer

Generic Name
Glatiramer
Brand Names
Copaxone, Glatect, Glatopa
Drug Type
Biotech
CAS Number
28704-27-0
Unique Ingredient Identifier
U782C039QP
Background

Glatiramer acetate is a mix of synthetic polypeptides that includes L-glutamic acid, L-alanine, L-tyrosine, and L-lysine at an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. Since glatiramer acetate is a heterogeneous drug, there is limited information about its physicochemical properties. Originally, glatiramer acetate was designed as a stimulant of myelin basic protein (MBP), a myelin antigen involved in the development of multiple sclerosis (MS), to induce experimental autoimmune encephalitis (MS animal model). However, the opposite was observed. Glatiramer acetate exhibits several immunomodulatory effects and reduces the relapse rate of relapsing-remitting multiple sclerosis (RRMS) by 30%. Along with human interferon beta, teriflunomide, and dimethyl fumarate, glatiramer acetate is a first-line drug for patients with MS. It was approved by the FDA in 1996, and a generic version became available in 2017.

Indication

Glatiramer acetate is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Associated Conditions
Clinically Isolated Syndrome (CIS), Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis (RRMS), Active Secondary Progressive Multiple Sclerosis (SPMS)

Therapy Optimization in Multiple Sclerosis (MS)

First Posted Date
2009-01-08
Last Posted Date
2013-01-29
Lead Sponsor
Teva Neuroscience, Inc.
Target Recruit Count
2878
Registration Number
NCT00819000
Locations
🇺🇸

Teva Investigational Site, Carnegie, Pennsylvania, United States

Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis

Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2009-01-08
Last Posted Date
2013-10-08
Lead Sponsor
University of California, San Francisco
Target Recruit Count
17
Registration Number
NCT00819195
Locations
🇺🇸

UCSF Multiple Sclerosis Center, San Francisco, California, United States

Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis

Phase 2
Completed
Conditions
Multiple Sclerosis
Interventions
Drug: Placebo (for teriflunomide)
Drug: Interferon-β [IFN-β]
First Posted Date
2008-12-19
Last Posted Date
2012-12-31
Lead Sponsor
Sanofi
Target Recruit Count
182
Registration Number
NCT00811395
Locations
🇬🇧

Sanofi-Aventis Administrative Office, Guildford, United Kingdom

A Double Blind Placebo Control Study to Assess the Safety,Tolerability and Efficacy of Copaxone in Crohn's Disease

Phase 2
Conditions
Crohns Disease
Interventions
First Posted Date
2008-08-08
Last Posted Date
2009-03-03
Lead Sponsor
Tel-Aviv Sourasky Medical Center
Target Recruit Count
50
Registration Number
NCT00731172
Locations
🇮🇱

Tel Aviv Sourasky medical center, Tel Aviv, Israel

🇮🇱

Weizmann Institute of Science, Rehovot, Israel

Effects of Copaxone in the Retinal Function in Diabetic Patients After Panphotocoagulation

Phase 4
Conditions
Diabetic Retinopathy
Interventions
First Posted Date
2008-05-14
Last Posted Date
2008-05-14
Lead Sponsor
Federal University of São Paulo
Target Recruit Count
30
Registration Number
NCT00677664
Locations
🇧🇷

Federal University of Sao Paulo, Sao Paulo, SP, Brazil

Evaluate Early Glatiramer Acetate Treatment in Delaying Conversion to Clinically Definite Multiple Sclerosis of Subjects Presenting With Clinically Isolated Syndrome

Phase 3
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2008-04-24
Last Posted Date
2012-06-25
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
481
Registration Number
NCT00666224

Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis

Phase 2
Completed
Conditions
Multiple Sclerosis
Interventions
Drug: Placebo (for teriflunomide)
First Posted Date
2007-05-21
Last Posted Date
2012-11-06
Lead Sponsor
Sanofi
Target Recruit Count
123
Registration Number
NCT00475865
Locations
🇬🇧

Sanofi-Aventis Administrative Office, Guildford, United Kingdom

Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis

Phase 3
Completed
Conditions
Relapsing-Remitting Multiple Sclerosis
Interventions
First Posted Date
2007-03-23
Last Posted Date
2015-01-26
Lead Sponsor
Biogen
Target Recruit Count
1417
Registration Number
NCT00451451
Locations
🇺🇦

Research Site, Zaporozhye, Ukraine

An fMRI Study of Treatment Optimization Comparing Two Disease Modifying Therapies Used to Treat Relapsing Remitting Multiple Sclerosis

Terminated
Conditions
Relapsing-Remitting Multiple Sclerosis
First Posted Date
2006-11-10
Last Posted Date
2007-12-05
Lead Sponsor
Neurognostics
Target Recruit Count
48
Registration Number
NCT00398528
Locations
🇺🇸

University of Southern California, Los Angeles, California, United States

🇺🇸

Aurora St. Luke's Medical Center, Milwaukee, Wisconsin, United States

🇺🇸

Minor & James Medical, Seattle, Washington, United States

and more 2 locations
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