A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects

• Register: EUCTR
• Last refreshed on: 8 May 2012
• Main ID: EUCTR2004-003943-28-HU
• Date of registration: 13/12/2004
• Prospective Registration: Yes
• Primary sponsor: Teva Pharmaceutical Industries Ltd
• Public title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects
• Scientific title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects
• Date of first enrolment: 14/02/2005
• Target sample size: 265
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-003943-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Czech Republic, Germany, Hungary, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subjects must have a confirmed MS diagnosis as defined by the McDonald criteria (Ann Neurol, July 2001).
2. Subjects must have an R-R MS disease course.
3. Subjects must have at least one documented relapse in the 12 months prior to screening.
4. Subjects must have at least one gadolinium-enhanced (Gd; gadopentetic acid) lesion on their screening MRI scan.
5. Subjects must be ambulatory with a Kurtzke EDSS score of 1.0-5.0 (converted).
6. Subjects must be between 18-50 years of age, inclusive.
7. Subjects must be relapse-free and off corticosteroids or ACTH for at least 30 days prior to the MRI scan at screening.
8. Subjects must be relapse-free and off corticosteroids between screening and randomization (baseline V0).
9. Women of child-bearing potential must practice a reliable method of birth control. (Acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices and diaphragms with spermicide; oral contraception must be accompanied by an additional method of birth control.)
10. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
11. Subjects must be able to give signed, 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

Exclusion criteria:
1. Subjects who suffer from any form of progressive MS.
2. Use of immunosuppressive or cytotoxic treatments within 6 months prior to the screening visit (including azathioprine, cyclophosphamide methotrexate).
3. Use of experimental drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
4. Previous treatment with immunomodulators (including IFNß 1a and 1b glatiramer acetate, laquinimod and IVIG) within the 2 months prior to screening.
5. Use of potent inhibitors of CYP3A4, such as oral ketoconazole or erythromycin within 2 weeks prior to baseline visit (see full list in Appendix 6).
6. Previous use of amiodarone.
7. Use of fluoxetine one month prior to baseline visit.
8. Use of the following substrates of CYP1A2: theophylline and warfarin within 2 weeks prior to screening.
9. Previous treatment with cladribine within the last 2 years prior to screening visit.
10. Subjects for whom potential immunosuppression would be contraindicated, for example: Hepatitis B/C or HIV.
11. Previous total body irradiation or total lymphoid irradiation.
12. Chronic corticosteroid treatment (30 or more consecutive days) within the 2 months prior to screening.
13. Pregnancy or breastfeeding.
14. 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, chest X-ray.
15. The subject's inability to give informed consent, or to complete the study, or if the subject is considered by the investigator to be, for any reason, an unsuitable candidate for this study.
16. A known history of sensitivity to Gd.
17. Inability to successfully undergo MRI scanning.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Relapsing Remitting Multiple Sclerosis
MedDRA version: 5.1 Level: PT Classification code 10028245

Intervention(s)

Product Name: Laquinimod Tablets 0.3 mg
Product Code: ABR-215062 sodium salt
Pharmaceutical Form: Tablet
INN or Proposed INN: laquinimod
CAS Number: 248282-07-7
Current Sponsor code: ABR-215062 sodium salt
Other descriptive name: PNU-215062 sodium salt
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.3-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): The cumulative number of enhancing lesions on T1-weighted images taken on weeks 12, 16, 20, 24, 28, 32 and 36 (primary end point).

Secondary Objective:

Main Objective: To assess the efficacy, tolerability and safety of two doses of laquinimod compared to placebo in R-R MS subjects, as measured by Magnetic Resonance Imaging (MRI) and clinical parameters

Secondary ID(s)

LAQ/5062