A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO
- Conditions
- Relapsing Remitting Multiple Sclerosis (RRMS)MedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
- Registration Number
- EUCTR2007-005450-23-BG
- Lead Sponsor
- Teva Pharmaceutical Industries Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1200
1.Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria [Ann Neurol 2005: 58:840-846], with a relapsing-remitting disease course.
2.Subjects must be ambulatory with Converted EDSS score of 0-5.5 in both screening and baseline visits.
3.Subjects must be in a stable neurological condition and free of corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)] 30 days prior to screening (month -1) and between screening (month -1) and baseline (month 0) visits.
4.Subjects must have had 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.Subjects must have disease duration of at least 6 months (from the first symptom) prior to screening.
7.Women of child-bearing potential must practice an acceptable method of birth control [acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner’s vasectomy or a double-protection method (condom or diaphragm with spermicide)].
8.Subjects must be able to sign and date a written informed consent prior to entering the study.
9.Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
1. An onset of relapse or any treatment with corticosteroids (intravenous [IV],
intramuscular [IM] and/or per os [PO]) or ACTH between month -1 (screening)
and 0 (baseline).
2. Subjects with progressive forms of MS.
3. Use of experimental or investigational drugs, and/or participation in drug clinical
studies within the 6 months prior to screening.
4. Use of immunosuppressive (including Mitoxantrone (Novantrone®) or cytotoxic
agents within 6 months prior to the screening visit.
5. Previous use of either of the following: natalizumab (Tysabri®), cladribine,
laquinimod, Interferon beta-1a (Avonex® or Rebif®), Interferon beta-1b
(Betaseron®/Betaferon®) or any other experimental Interferon-beta for MS.
6. Previous treatment with glatiramer acetate (Copaxone®) or IVIG within 2 months
prior to screening visit.
7. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid
treatment within 2 months prior to screening visit.
8. Previous total body irradiation or total lymphoid irradiation.
9. Previous stem-cell treatment, autologous bone marrow transplantation or
allogenic bone marrow transplantation.
10. A known history of tuberculosis.
11. Acute infection within 2 weeks prior to baseline visit.
12. Major trauma or surgery within 2 weeks prior to baseline visit.
13. A history of vascular thrombosis (excluding catheter-site superficial venous
thrombophlebitis).
14. A carrier state of factor V Leiden mutation (either homo- or heterozygous) by
history or as disclosed at screening.
15. Positive screening test for Hepatitis B surface antigen or Hepatitis C antibody as
disclosed at screening visit.
16. Known human immunodeficiency virus (HIV) positive status.
17. Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit
18. Use of amiodarone within 2 years prior to screening visit.
19. Pregnancy or breastfeeding.
20. Subjects with a clinically significant or unstable medical or surgical condition that,
in the Investigator's opinion, would preclude safe and complete study
participation, as determined by medical history, physical examinations, ECG,
laboratory tests or chest X-ray.
21. A known history of sensitivity to Gadolinium.
22. Inability to successfully undergo MRI scanning.
23. A known drug hypersensitivity that would preclude administration of
laquinimod, such as hypersensitivity to: mannitol, meglumine or sodium stearyl
fumarate.
24. A known history of hypersensitivity to natural or recombinant interferon beta,
human albumin, or any other component of the formulation of Avonex®.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method