EUCTR2007-003226-19-IT进行中（未招募）不适用
A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS). - Allegro
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 Kurtzke EDSS score of 0-5.5.
- •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).
- •4.Subjects must have had experienced one of the following:
- •At least one documented relapse in the 12 months prior to screening
- •At least two documented relapses in the 24 months prior to screening
- •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 double-barrier method (condom or diaphragm with spermicide).
- •8.Subjects must be able to sign and date a written informed consent prior to entering 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
排除标准
- •1.Subjects with progressive forms of MS
- •2.An onset of relapse, unstable neurological condition or any treatment with corticosteroids [intravenous (iv), intramuscular (im) and/or per os (po)] or ACTH between month -1 (screening) and 0 (baseline).
- •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.
- •6.Previous treatment with glatiramer acetate (Copaxone) Interferon-β (either 1a or 1b) or IVIG within 2 months prior to screening visit.
- •7.Systemic corticosteroid treatment of ≥30 consecutive days duration 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 two weeks prior to baseline visit.
- •12.Major trauma or surgery two weeks prior to baseline
- •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) as disclosed at screening.
- •15.Positive screening test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV antibody as disclosed at screening visit.
- •16.Use of potent inhibitors of CYP3A4 within 2 weeks prior to baseline visit (1 month for fluoxetine) see detailed list in
- •17.Use of amiodarone within 2 years prior to screening visit.
- •18.Pregnancy or breastfeeding.
- •19.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 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 or metabolic diseases.
- •Any form of chronic liver disease, including known non-alcoholic steatohepatitis.
- •A ≥2xULN serum elevation of either of the following at screening: ALT, AST or direct bilirubin
- •A QTC interval (obtained from either 2 ECG recordings at screening or from the mean value calculated from 3 measurements at baseline visit) which is >450msec.
- •A family history of Long- QT syndrome.
- •A history of drug and/or alcohol abuse.
- •Major psychiatric disorder.
- •20.A known history of sensitivity to Gd.
- •21.Inability to successfully undergo MRI scanning.
- •22.Known drug hypersensitivity that would preclude administration of laquinimod, such as hypersensitivity to: mannitol, meglumine or sodium stearyl fumarate.
研究者
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