Primary and secondary progressive MS subjects in clinical trials: Are they similar?

Objective: To characterize the primary progressive (PPMS) and secondary progressive (SPMS) MS subjects enrolled in a Phase II clinical trial. Background: There is growing evidence that PPMS and SPMS are more similar than different. Differences among subjects with these forms of MS enrolling into clinical trials are not well understood, but may have a significant impact on the outcome of trials. Design/Methods: NN 102/SPRINT-MS is a phase II trial of ibudilast in primary and secondary progressive MS utilizing the NINDS-sponsored NeuroNEXT clinical trial network. Subjects were enrolled at 28 US sites, randomized 1:1 to ibudilast 100mg/d or placebo, and are being followed over 96 weeks. Enrollment was open to both PPMS and SPMS patients, with the same inclusion and exclusion criteria applied to both groups. Two sample t-tests were used to compare the means of clinical and imaging variables. Results: Of 314 enrolled subjects, there were 261 unique subjects with sufficient clinical and imaging data at screening for inclusion in this analysis. There was no difference in age (SPMS 55.8y, PPMS 55.2y), 9-hole peg test time (SPMS 36.9s, PPMS 32.9s), or Symbol Digit Modality Test score (SPMS 43.4, PPMS 40.4) (all pu003e0.05). However, SPMS had longer disease duration (16.2y vs 7.8y PPMS; p Conclusions: Despite identical inclusion and exclusion criteria, PPMS and SPMS subjects enrolling into the same clinical trial had different clinical and imaging disease characteristics. These differences may have a significant impact on the results of the clinical trial and should be considered when analyzing the results of studies that enroll both disease types. Study Supported by: Support by National Institute of Health (U01NS082329), NeuroNEXT Network (Central Coordinating Center: U01NS077179; Data Coordinating Center: U01NS077352), National Multiple Sclerosis Society (RG-5184-A-6) and Medicinova Disclosure: Dr. Fox has received personal compensation for activities with Actelion, Biogen, Genentech, Mallinckrodt, MedDay, Novartis, and Teva Neuroscience as a consultant. Dr. Fox has received research support from Novartis. Dr. Ashokkumar has nothing to disclose. Dr. Coffey has received consulting fees from ZZ Biotech, LLC.,,,,,, Dr. Conwit has nothing to disclose. Dr. Cudkowicz has received personal compensation for activities with Cytokinetics, Lilly, Astra Zenica, Biohaven, Genentech. Jama Neurology. Dr. Ecklund has nothing to disclose. Dr. Gleason has nothing to disclose. Dr. Goodman received personal compensation for activities with Abbvie, Acorda Therapeutics, Atara, Bayer HealthCare, Biogen, Novartis, Sanofi-Genzyme, and Teva. Dr. Goodman has received research support from Acorda, Avanir, Biogen, EMD-Serono, Novartis, Ono, Roche, Sanofi-Genzyme, Sun and Teva. Dr. Klawiter has received personal compensation for activities with Atlas5d, Biogen Idec, EMD Serono, Genentech, and Shire as a consultant. Dr. Klawiter has received research support for clinical research projects and clinical trials from Atlas5d, Biogen, EMD Serono, and Roche.. Dr. Koepp has nothing to disclose. Dr. Matsuda has received personal compensation for activities with MediciNova. Dr. McGovern has nothing to disclose. Dr. Naismith has received personal compensation for activities with Acorda, Alkermes, Bayer, Biogen, EMD Serono, Genentech, Genyzme, Novartis, and Teva. Dr. Naismith has received research support from Alkermes. Dr. Natarajan has nothing to disclose. Dr. Thornell has nothing to disclose. Dr. Yankey has nothing to disclose.