A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo (GALA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01067521
First received: February 10, 2010
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

The study is designed to assess the efficacy of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in subjects with RRMS, as measured by the number of confirmed relapses during the 12 month placebo controlled phase. The study has two phases:

  • Placebo Controlled Phase: 12 months of 40 mg administered three times a week by subcutaneous injection or matching placebo.
  • Open Label Extension: All subjects will continue treatment with GA 40 mg administered three times a week, until this dose strength is commercially available for the treatment of relapsing remitting multiple sclerosis (RRMS) patients or until the development of this GA dose regimen is stopped by the Sponsor

Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
Drug: Glatiramer acetate (GA)
Other: Placebo
Phase 3

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 Multinational, Multicenter, Randomized, Parallel-group Study in Subjects With Relapsing-Remitting Multiple Sclerosis to Assess Efficacy, Safety and Tolerability of Glatiramer Acetate Injection 40mg Compared to Placebo in a Double-blind Design

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • The total number of confirmed relapses during the 12 month PC phase [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of new T2 lesions at month 12 (end of PC phase) as compared to baseline scan. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The cumulative number of enhancing lesions on T1-weighted images taken at months 6 and 12 (end of PC phase). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Status of Gd-enhancing T1 activity at baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    =0 if the subject has no Gd-enhancing T1 lesions at baseline; =1 if the subject has at least one Gd-enhancing T1 lesion at baseline


Enrollment: 1404
Study Start Date: May 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GA 40 mg Drug: Glatiramer acetate (GA)
GA 40 mg administered 3 times a week by subcutaneous injection for a period of 12 months
Placebo Comparator: Placebo Other: Placebo
Placebo comparator

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria with a relapsing-remitting disease course.
  2. Subjects must be ambulatory with an EDSS score of 0-5.5 in both screening and baseline visits.
  3. Subjects must be in a relapse-free, stable neurological condition and free of corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)] or ACTH 30 days prior to screening (month -1) and between screening and baseline (month 0) visits.
  4. Subjects must have experienced one of the following:

    At least one documented relapse in the 12 months prior to screening, or At least two documented relapses in the 24 months prior to screening, or One documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in an MRI performed within 12 months prior to screening.

  5. Subjects must be between 18 and 55 years of age, inclusive.
  6. Women of child-bearing potential must practice an acceptable method of birth control.
  7. Subjects must be able to sign and date a written informed consent prior to entering the study.
  8. Subjects must be willing and able to comply with the protocol requirements for the duration of the study

Exclusion Criteria:

  1. Subjects with progressive forms of MS.
  2. Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
  3. Use of immunosuppressive (including Mitoxantrone and Fingolimod) or cytotoxic agents within 6 months prior to the screening visit.
  4. Use of natalizumab (Tysabri®) or any other monoclonal antibodies within 2 years prior to screening.
  5. Use of cladribine within 2 years prior to screening.
  6. Previous treatment with immunomodulators (including IFNβ 1a and 1b, and IV Immunoglobulin (IVIg) within 2 months prior to screening.
  7. Previous use of GA or any other glatiramoid.
  8. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit.
  9. Previous total body irradiation or total lymphoid irradiation.
  10. Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
  11. Pregnancy or breastfeeding.
  12. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical exams, ECG, abnormal laboratory tests and chest X-ray. Such conditions may include hepatic, renal or metabolic diseases, systemic disease, acute infection, current malignancy or recent history (5 years) of malignancy, major psychiatric disorder, history of drug and/or alcohol abuse and allergies that could be detrimental according to the investigator's judgment.
  13. A known history of sensitivity to Gadolinium.
  14. Inability to successfully undergo MRI scanning.
  15. A known drug hypersensitivity to Mannitol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067521

  Show 159 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01067521     History of Changes
Other Study ID Numbers: MS-GA-301
Study First Received: February 10, 2010
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Relapsing Remitting Multiple Sclerosis
Glatiramer Acetate

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
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on July 29, 2014