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MS Trial Alert - Large Study of Oral Laqunimod Seeking Participants

Mar 07, 2008

MS Trial Alert - Large Study of Oral Laqunimod Seeking Participants

Summary:

Investigators at sites worldwide are studying oral laquinimod (Teva Pharmaceuticals), a drug that is believed to modify immune function, in 1,000 people globally with relapsing-remitting MS (RR MS, a course of MS characterized by clearly defined flare-ups followed by complete or partial remissions).

Rationale:

Multiple sclerosis occurs when the immune system mistakenly attacks nerve fiber-insulating myelin and other brain and spinal cord tissues. Results of an earlier study in 306 people showed that 0.6 mg of laquinimod (but not 0.3 mg) reduced the total number of active lesions (areas of myelin damage) that appeared over 36 weeks by 60% when compared with placebo. The new study is comparing the higher dose against placebo. At the 2007 annual meeting of the European Committee on Treatment and Research in Multiple Sclerosis, researchers reported that the drug reduced inflammation, myelin damage, and damage to nerve fibers themselves in mice with an MS-like disease, indicating that laquinimod may also have neuroprotective effects, although this has not been shown in people with MS.

Eligibility and Details:

Participants must be between 18 and 55 years of age, with a diagnosis of relapsing-remitting MS, and at least one MS relapse in the 12 months before screening; or two relapses in the 24 months before screening; or one relapse within 24 months and one active lesion observed on MRI. Individuals considering enrolling must be aware of other treatment options open to them before agreeing to participate.

Participants will be randomly assigned to receive either laquinimod 0.6 mg (one capsule daily) or inactive placebo for 24 months. Subjects completing this “core” study will be offered the opportunity to enroll in an open-label (meaning no placebo group), extension study in which all patients will take the study drug.

The primary goal of the study is to determine the effect of laquinimod on the number of relapses during the 24-month core study. Secondary goals are to evaluate its effect on the EDSS, a scale commonly used to measure MS-related disability, and on disease activity as observed on MRI scans.

Contact:

For enrollment information, please visitwww.tevaclinicaltrials.com, or our Web section on Trials Recruiting Patients, where individual contact information is listed for each site by state.Please note that not all sites are enrolling patients yet, and only those that are currently enrolling will be listed.Sites will be listed in the following states:

ArizonaColoradoConnecticutIllinoisIndianaIowaKansasKentuckyMichiganMinneapolis MissouriNew YorkNorth CarolinaNorth DakotaOhioOklahomaPennsylvaniaTennesseeTexasWisconsin

For information about sites outside of the U.S., visit the study listing onwww.ClinicalTrials.gov.