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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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12 May 2014 |
Main ID: |
EUCTR2007-005450-23-EE |
Date of registration:
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11/02/2008 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
Date of first enrolment:
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28/03/2008 |
Target sample size:
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1200 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005450-23 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: Third arm comparator, rater-blinded
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: yes
Other specify the comparator: Avonex 30 microgram/0.5 ml Solution for Injection
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Phase:
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Countries of recruitment
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Bulgaria
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Czech Republic
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Estonia
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Germany
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Italy
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Lithuania
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Spain
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Key inclusion & exclusion criteria
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Inclusion criteria: 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.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)]. 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.
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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: 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 visit. 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 two weeks prior to baseline visit. 12. Major trauma or surgery within two weeks prior to baseline visit. 13. Known human immunodeficiency virus (HIV) positive status. 14. Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (see Appendix 5) 15. Use of amiodarone within 2 years prior to screening visit. 16. Pregnancy or breastfeeding. 17. A =3xULN serum elevation of either ALT or AST at screening. 18. Serum direct bilirubin which is =2xULN at screening 19. A QTc interval which is > 450 msec (according to machine output), obtained from: -Two ECG recordings at screening visit OR - The mean value calculated from 3 baseline ECG recordings 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. Such conditions may include: - A cardiovascular or pulmonary disorder that cannot be well-controlled by standard treatment permitted by the study protocol. - A gastrointestinal disorder that may affect the absorption of study medication. - Renal, metabolic or hematological diseases. - Thyroid disease: A subject with hyperthyroidism is not permitted to participate in the study. A subject with hypothyroidism may be permitted to participate in the study provided that he/she is clinically euthyroid and considered stable. - Liver disease, such as cirrhosis. - A family history of Long-QT syndrome. - A history of drug and/or alcohol abuse. - A current major psychiatric disorder, including schizophrenia or severe depression, with or without suicidal ideation. - A history of seizure disorder, with the last convulsive episode occurring within 12 months prior to screening visit. 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 com
Age minimum:
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1
Level: LLT
Classification code 10063399
Term: Relapsing-remitting multiple sclerosis
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Intervention(s)
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Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 Pharmaceutical Form: Capsule* INN or Proposed INN: Laquinimod CAS Number: 248282-07-7 Current Sponsor code: TV-5600 Other descriptive name: Laquinimod Sodium (USAN) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.6- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use
Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection Product Name: - Product Code: - Pharmaceutical Form: Solution for injection INN or Proposed INN: interferon beta-1a Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 30-
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Primary Outcome(s)
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Primary end point(s): The number of confirmed relapses during the treatment period.
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Main Objective: To assess the efficacy of 0.6 mg daily dose of laquinimod in patients with RRMS, as measured by the number of confirmed relapses during the treatment period.
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Secondary Objective: -To assess the effect of 0.6 mg daily dose of laquinimod on the development of brain atrophy as defined by the percent brain volume change from baseline at the end of the treatment period.
-To assess the effect of 0.6 mg daily dose of laquinimod on the accumulation of physical disability as measured by the time to confirmed progression of EDSS during the treatment period.
-To assess the effect of 0.6 mg daily dose of laquinimod on the accumulation of disability, as assessed by the MSFC score at the end of the treatment period.
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Secondary ID(s)
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MS-LAQ-302
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2007-005450-23-ES
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Source(s) of Monetary Support
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Results
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Results available:
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