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Author Notes:

Corresponding Author: Robert J Fox, Mellen Center for Multiple Sclerosis, Cleveland Clinic, 9500 Euclic Avenue, U10, Cleveland, OH 44195, Tel: 216-445-1915; Fax: 216-445-5192; foxr@ccf.org

See publication for full list of author contributions.

We thank Dr. Elizabeth McNeil, the former program manager at NINDS, for her steady support through the trial development and start-up process.

This study was made possible by the dedication and support of people with MS who volunteered to participate as well as their families and friends who support their involvement in this study.

For a complete list of authors' conflicts of interest, please see the full work.

Subject:

Research Funding:

This study was funded by the NINDS (U01NS082329) and NMSS (RG 4778-A-6).

Ibudilast study drug was provided at no cost by MediciNova Inc.

The NeuroNEXT Network is supported by the NINDS (Central Coordinating Center: U01NS077179, Data Coordinating Center: U01NS077352).

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Medicine, Research & Experimental
  • Pharmacology & Pharmacy
  • Research & Experimental Medicine
  • Clinical trial
  • Ibudilast
  • Progressive multiple sclerosis
  • Magnetic resonance imaging
  • BRAIN ATROPHY
  • FUNCTIONAL COMPOSITE
  • PHOSPHODIESTERASE INHIBITORS
  • MECHANICAL ALLODYNIA
  • NEUROPATHIC PAIN
  • LESION LOAD
  • RATS
  • NEUROPROTECTION
  • IMPAIRMENT
  • DISABILITY

Design, rationale, and baseline characteristics of the randomized double-blind phase II clinical trial of ibudilast in progressive multiple sclerosis

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Journal Title:

Contemporary Clinical Trials

Volume:

Volume 50

Publisher:

, Pages 166-177

Type of Work:

Article | Post-print: After Peer Review

Abstract:

Background Primary and secondary progressive multiple sclerosis (MS), collectively called progressive multiple sclerosis (PMS), is characterized by gradual progression of disability. The current anti-inflammatory treatments for MS have little or no efficacy in PMS in the absence of obvious active inflammation. Optimal biomarkers for phase II PMS trials is unknown. Ibudilast is an inhibitor of macrophage migration inhibitor factor and phosphodiesterases-4 and − 10 and exhibits possible neuroprotective properties. The goals of SPRINT-MS study are to evaluate the safety and efficacy of ibudilast in PMS and to directly compare several imaging metrics for utility in PMS trials. Methods SPRINT-MS is a randomized, placebo-controlled, phase II trial of ibudilast in patients with PMS. Eligible subjects were randomized 1:1 to receive either ibudilast (100 mg/day) or placebo for 96 weeks. Imaging is conducted every 24 weeks for whole brain atrophy, magnetization transfer ratio, diffusion tensor imaging, cortical brain atrophy, and retinal nerve fiber layer thickness. Clinical outcomes include neurologic disability and patient reported quality of life. Safety assessments include laboratory testing, electrocardiography, and suicidality screening. Results A total of 331 subjects were enrolled, of which 255 were randomized onto active study treatment. Randomized subjects were 53.7% female and mean age 55.7 (SD 7.3) years. The last subject is projected to c omplete the study in May 2017. Conclusion SPRINT-MS is designed to evaluate the safety and efficacy of ibudilast as a treatment for PMS while simultaneously validating five different imaging biomarkers as outcome metrics for use in future phase II proof-of-concept PMS trials.

Copyright information:

© 2016 Elsevier Inc.

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