We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01067521
First Posted: February 11, 2010
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )
February 10, 2010
February 11, 2010
November 17, 2017
May 31, 2010
May 7, 2012   (Final data collection date for primary outcome measure)
The total number of confirmed relapses during the 12 month PC phase [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01067521 on ClinicalTrials.gov Archive Site
  • The number of new T2 lesions at month 12 (end of PC phase) as compared to baseline scan. [ Time Frame: 12 months ]
  • The cumulative number of enhancing lesions on T1-weighted images taken at months 6 and 12 (end of PC phase). [ Time Frame: 12 months ]
  • Status of Gd-enhancing T1 activity at baseline [ Time Frame: Baseline ]
    =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
  • The number of new T2 lesions at month 12 (end of PC phase) as compared to baseline scan. [ Time Frame: 12 months ]
  • The cumulative number of enhancing lesions on T1-weighted images taken at months 6 and 12 (end of PC phase). [ Time Frame: 12 months ]
Not Provided
Not Provided
 
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
A Multinational, Multicenter, Randomized, Parallel-group Study Performed 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 in a Double-blind Design

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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Relapsing Remitting Multiple Sclerosis
  • Drug: Glatiramer acetate (GA)
    GA 40 mg administered 3 times a week by subcutaneous injection for a period of 12 months
  • Other: Placebo
    Placebo comparator
  • Experimental: GA 40 mg
    Intervention: Drug: Glatiramer acetate (GA)
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Khan O, Rieckmann P, Boyko A, Selmaj K, Ashtamker N, Davis MD, Kolodny S, Zivadinov R. Efficacy and safety of a three-times-weekly dosing regimen of glatiramer acetate in relapsing-remitting multiple sclerosis patients: 3-year results of the Glatiramer Acetate Low-Frequency Administration open-label extension study. Mult Scler. 2017 May;23(6):818-829. doi: 10.1177/1352458516664033. Epub 2016 Aug 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1404
May 12, 2017
May 7, 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Croatia,   Czechia,   Estonia,   Georgia,   Germany,   Hungary,   Israel,   Italy,   Lithuania,   Poland,   Romania,   Russian Federation,   South Africa,   Ukraine,   United Kingdom,   United States
Czech Republic,   Turkey
 
NCT01067521
MS-GA-301
2009-018084-27 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )
Teva Pharmaceutical Industries, Ltd.
Not Provided
Not Provided
Teva Pharmaceutical Industries
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP