MS Trial Alert: Large Study of Oral Laquinimod Seeking People with Relapsing-Remitting MS

Summary:

Investigators at sites worldwide are seeking volunteers for a clinical trial studying oral laquinimod (Teva Pharmaceuticals) in comparison with inactive placebo or interferon beta-1a (Avonex^®, Biogen Idec) in 1200 people with relapsing-remitting MS (RR MS, a course of MS characterized by clearly defined flare-ups followed by complete or partial remissions). The study is funded by Teva Neuroscience.

Rationale:

Multiple sclerosis occurs when the immune system mistakenly attacks nerve fiber-insulating myelin and other brain and spinal cord tissues. Laquinimod is believed to affect this attack. Oral laquinimod (Teva Pharmaceutical Industries) reduced disease activity by 40.4% compared with inactive placebo in a phase 2 study of 306 people with relapsing-remitting MS. (Lancet 2008; 371: 2085–92) A phase 3 study of laquinimod versus inactive placebo is currently underway in 1000 people with relapsing-remitting 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. Exclusion criteria include previous use of interferon beta, among other drugs. Please use the contact information below to find out about further inclusion/exclusion criteria.

Participants will be randomly assigned to receive either laquinimod 0.6 mg (one capsule daily), inactive placebo, or Avonex 30 mcg/wk 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 subjects 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 include impacts on disease activity as observed on MRI scans and accumulation of disability.

Contact:

To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please visithttp://www.tevaclinicaltrials.com/, or call 1-800-840-5601. Sites are enrolling in the cities listed below.

Alabama - NorthportArizona – Phoenix, TucsonCalifornia – Pasadena, SacramentoFlorida – Orlando, SarasotaGeorgia – AtlantaIllinois – Peoria, Indiana – Indianapolis Kansas - LenexaLouisiana – New Orleans, ShreveportMaryland - BaltimoreMichigan – Grand RapidsNevada – Las VegasNew Hampshire – LebanonNew York – Albany, Amherst, CedarhurstNorth Carolina – Raleigh, Winston-SalemOregon – PortlandOhio – Akron, Cleveland, ColumbusPuerto Rico - GuaynaboTexas – San AntonioTennessee - NashvilleVirginia – Richmond, Roanoke Washington – Tacoma

For information about sites outside of the U.S., visit thestudy listingon ClinicalTrials.gov.

Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).

Avonex is a registered trademark of Biogen Idec.