A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course
Status: | Terminated |
---|---|
Conditions: | Neurology, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 1/10/2019 |
Start Date: | November 10, 2009 |
End Date: | July 1, 2017 |
A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-301 (ALLEGRO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing MS
The purpose of this study is to make laquinimod 0.6 mg available for all subjects who
completed the placebo-controlled MS-LAQ-301 study according to the protocol and to evaluate
the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6
mg in subjects with relapsing multiple sclerosis.
completed the placebo-controlled MS-LAQ-301 study according to the protocol and to evaluate
the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6
mg in subjects with relapsing multiple sclerosis.
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 must practice an acceptable method of birth control
[acceptable methods of birth control in this open label extension phase include:
surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch
(or hormone-releasing vaginal ring), long-acting injectable contraceptive, partner's
vasectomy or double-barrier method (condom or diaphragm with spermicide)] during the
study and up to 30 days after the last dose of the study drug..
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.
Exclusion Criteria:
1. Premature discontinuation from the MS-LAQ-301 study, for any reason.
2. Pregnancy [according to urine dipstick β-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).
We found this trial at
21
sites
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