A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.

Phase 1

• Conditions: aquinimod is developed for the treatment of relapsing remitting multiple sclerosis.; MedDRA version: 19.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2009-012989-30-LT
• Lead Sponsor: Teva Pharmaceutical Industries Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-02
• Last Update Posted: 29 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 542

Inclusion Criteria

1.Subjects must have completed the Termination visit of MS-LAQ-301 (completion of all Termination visit activities) according to the MS-LAQ-301 protocol.
2. Women of child-bearing potential (for example women who are not
postmenopausal or surgically sterilized) must practice two acceptable
methods of birth control for the duration of the study and until 30 days
after the last dose of study medication [acceptable methods of birth
control in this open label extension phase include: intrauterine devices,
barrier methods (condom or diaphragm with spermicide), and hormonal
methods of birth control (e.g. oral contraceptive, contraceptive patch,
and long-acting injectable contraceptive)].
3.Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
4.Subjects must be able to comprehend, sign and date a written informed consent prior to entering the MS-LAQ-301E 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 542
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria:
1.Premature discontinuation from the MS-LAQ-301 study, for any reason.
2.Pregnancy [according to urine dipstick ß-HCG test performed at Baseline (Month 0E) visit] or breastfeeding.
3.Subjects with clinically significant or unstable medical or surgical condition detected or worsened during the MS-LAQ-301 study, which preclude safe participation and completion of the MS-LAQ-301E study. Acute exacerbation of MS will not exclude participation in the MS-LAQ-301E study.
4.Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified