Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis (RRMS). This study is planned to assess the tolerability and safety of escalating doses of oral laquinimod administered daily in subjects with RRMS. MedDRA version: 15.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: laquinimod
CAS Number: 248282-07-7
Current Sponsor code: TV-5600
Other descriptiv
Sponsors
Teva Pharmaceutical Industries Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must have a confirmed and documented diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS), as defined by the Revised McDonald criteria [Ann Neurol 2005: 58:840-846]. 2. Subjects must have had experienced at least one documented relapse in the 3 years prior to screening. 3. Subjects must be ambulatory with an EDSS score of 0-5.5 at screening. 4. Subjects must be between 18 and 55 years of age, inclusive. 5. Subjects must be relapse-free and in a stable neurological condition at least 30 days prior to screening. 6. Women of child-bearing potential must practice a highly effective method of birth control [acceptable methods of birth control in this study include: surgical sterilization, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, hormonal intrauterine devices or partner's vasectomy. Subjects using a non-hormonal IUD will be required to use an additional hormonal or barrier method]. 7. Subjects must be willing and able to give written informed consent and 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: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. An onset of relapse or any treatment with corticosteroids (intravenous [iv], intramuscular [im] and/or per os [po]) or ACTH between Day -7 (screening) and 0 (baseline). 2. Use of experimental or investigational drugs, and/or participation in clinical drug studies within 6 months prior to screening. 3. Use of immunosuppressive (including Mitoxantrone and Natalizumab) or cytotoxic agents within 6 months prior to the screening visit. 4. Previous use of laquinimod. 5. Treatment with glatiramer acetate (Copaxone®), Interferon beta-1a (Avonex®, Rebif®), Interferon beta-1b (Betaseron®) or IVIG within 1 month prior to screening visit. 6. A known history of tuberculosis. 7. Positive screening test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV antibody. 8. Use of inhibitors of CYP3A4 within 2 weeks prior to the screening visit (3 weeks for fluoxetine). 9. Use of amiodarone within 2 years prior to screening visit. 10. Pregnancy or breastfeeding. 11. 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, laboratory tests or imaging. 12. Known hypersensitivity that would preclude administration of laquinimod, such as to the following: mannitol, meglumine or sodium stearyl fumarate. 13. 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. 14. Use of inducers of CYP3A4 within 2 weeks prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study is aimed to assess the safety and tolerability profile of ascending doses of laquinimod administered daily in subjects with RRMS, and is safety oriented in nature; therefore, no formal hypothesis testing is planned.;Secondary Objective: Pharmacokinetic assessment. The relationship between tolerability and safety measures and exposure may be assessed as deemed appropriate.;Primary end point(s): There is no primary endpoint in this study. This study is aimed to assess the safety and tolerability profile of ascending doses of laquinimod administered daily in subjects with RRMS, and is safety oriented in nature; therefore, no formal hypothesis testing is planned.;Timepoint(s) of evaluation of this end point: There is no primary endpoint in this study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): This study is aimed to assess the safety and tolerability profile of ascending doses of laquinimod administered daily in subjects with RRMS, and is safety oriented in nature; therefore, no formal hypothesis testing is planned.;Timepoint(s) of evaluation of this end point: This study is aimed to assess the safety and tolerability profile of ascending doses of laquinimod administered daily in subjects with RRMS, and is safety oriented in nature; therefore, no formal hypothesis testing is planned. | — |
Countries
Germany
Contacts
Public ContactDr. Matthias Roeckel
Teva Pharma GmbH
Outcome results
None listed