MS TRIAL ALERT: Investigators Recruiting for Study of Oral Laquinimod in Primary-Progressive MS
Summary: Investigators at sites worldwide are recruiting 375 people with primary-progressive MS for a Phase 2 clinical trial comparing oral laquinimod (Teva Pharmaceuticals), an experimental compound that is believed to modify immune function, with inactive placebo in 375 people with primary-progressive MS. The study is funded by Teva Pharmaceutical Industries Ltd.
Rationale: There are currently no disease-modifying therapies specifically approved for treating the primary-progressive form of MS. Laquinimod is an immune-modulating compound believed to affect the immune attack on the brain and spinal cord in MS. Previous results of large-scale clinical trials of laquinimod in people with relapsing-remitting MS have had mixed results. (New England Journal of Medicine 2012;366:1000-9; Journal of Neurology 261:773-83). Analyses of the trials focusing on groups of patients which approximate a progressive MS population, further provide a rationale for studying laquinimod in primary progressive MS. (Neurology 2014; 82[10] S4.001; Multiple Sclerosis Journal 2014;20[1 suppl]:99)
Eligibility and Details: Participants must be between 25 and 55 years of age, with a diagnosis of primary-progressive MS. More details on the enrollment criteria are available from the contacts below.
Participants will be randomly assigned to receive either laquinimod 0.6 mg, laquinimod 1.5 mg, or inactive placebo, by mouth. The primary goal of the study is to determine the effect of laquinimod on change in brain tissue volume ("atrophy"). Secondary goals are to evaluate its effects on disability progression, mobility, and disease activity as observed on MRI scans.
Contact: For enrollment information, please contact the site nearest you. The principal investigator (PI) and study coordinator (SC) for each U.S. site are listed below:
PI: Dr. Barbara Green
SC: Jessica Schulte
Mercy Clinic Neurology at The MS Center of Saint Louis
Chesterfield, MO
636-893-1258
PI: Dr. Barry Hendin
SC: Lynne Flynn
Phoenix Neurological Associates Ltd.
Phoenix, AZ
602-258-2863
PI: Dr. Daniel Bandari
SC: Ricky Cortes
Multiple Sclerosis Center of Southern California
Newport Beach, CA
949-631-2917
PI: Dr. Vernon Rowe
SC: Leigh Kreshel
MidAmerica NeuroScience Institute
Lenexa, KS
913-827-4262
PI: Dr. Christopher Sheppard
SC: Patti Blake
Oak Clinic for MS
Uniontown, OH
330-896-9625
PI: Dr. Daniel Wynn
SC: Cathy Myers
Consultants in Neurology, Ltd.
Northbrook, IL
847-509-0272
PI: Dr. Geoffrey Eubank
SC: Jamie Davis
Neurological Research Institute
Columbus, OH
614-457-4880
PI: Dr. Gary Birnbaum
SC: Neha Goyal
Minneapolis Clinic of Neurology
Golden Valley, MN
763-302-4072
PI: Dr. Jonathan Calkwood
SC: Alison Kolste
Minneapolis Clinic of Neurology
Golden Valley, MN
763-302-4175