Author Topic: Ibudilast receives fast track designation--studied for SPMS and PPMS (MSAA Research News)  (Read 384 times)

0 Members and 1 Guest are viewing this topic.

Offline agate

  • Administrator
  • *****
  • Posts: 9822
  • MS diagnosed 1980
  • Location: Pacific Northwest
From PubMed:

Quote
Contemp Clin Trials. 2016 Sep;50:166-77.

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

Fox RJ1, Coffey CS2, Cudkowicz ME3, Gleason T4, Goodman A5, Klawiter EC6, Matsuda K7, McGovern M3, Conwit R8, Naismith R9, Ashokkumar A2, Bermel R10, Ecklund D2, Koepp M2, Long J2, Natarajan S10, Ramachandran S10, Skaramagas T10, Thornell B3, Yankey J2, Agius M11, Bashir K12, Cohen B13, Coyle P14, Delgado S15, Dewitt D16, Flores A17, Giesser B18, Goldman M19, Jubelt B20, Lava N21, Lynch S22, Miravalle A23, Moses H24, Ontaneda D10, Perumal J25, Racke M26, Repovic P27, Riley C28, Severson C29, Shinnar S30, Suski V31, Weinstock-Gutman B32, Yadav V33, Zabeti A34.

Author information

1Cleveland Clinic, Neurological Institute, Cleveland, OH, United States. Electronic address: foxr@ccf.org.
2Data Coordinating Center, NeuroNEXT, University of Iowa, Iowa City, IA, United States.
3Clinical Coordinating Center, NeuroNEXT, Harvard Partners, Boston, MA, United States.
4Patient Advocate, Seattle, WA, United States.
5University of Rochester Medical Center, Rochester, NY, United States.
6Massachusetts General Hospital, Boston, MA, United States.
7Medicinova Inc., La Jolla, CA, United States.
8National Institutes of Neurological Disease and Stroke, Bethesda, MD, United States.
9Washington University School of Medicine, St. Louis, MO, United States.
10Cleveland Clinic, Neurological Institute, Cleveland, OH, United States.
11University of California at Davis, Sacramento, CA; currently at Barrows Neurological Institute, Phoenix, AZ, United States.
12University of Alabama at Birmingham, Birmingham, AL, United States.
13Northwestern University, Chicago, IL, United States.
14State University of New York, Stony Brook, NY, United States.
15University of Miami School of Medicine, Miami, FL, United States.
16University of Utah, Salt Lake City, UT, United States.
17University of Texas Southwestern Medical Center, Dallas, TX, United States.
18University of California at Los Angeles, Los Angeles, CA, United States.
19University of Virginia at Charlottesville, Charlottesville, VA, United States.
20State University of New York Upstate Medical University, Syracuse, NY, United States.
21Emory University, Atlanta, GA, United States.
22University of Kansas Medical Center, Kansas City, KS, United States.
23University of Colorado at Denver, Aurora, CO, United States.
24Vanderbilt University, Nashville, TN, United States.
25Weill Cornell Medical College, New York, NY, United States.
26The Ohio State University, Columbus, OH, United States.
27Swedish Medical Center at Seattle, Seattle, WA, United States.
28Columbia University Medical Center, New York, NY, United States.
29Brigham and Women's Hospital, Brookline, MA, United States.
30Montefiore Medical Center, Bronx, NY, United States.
31University of Pittsburgh Medical Center, Pittsburgh, PA, United States.
32State University of New York Buffalo, Buffalo, NY, United States.
33Oregon Health and Science University, Portland, OR, United States.
34University of Cincinnati, Cincinnati, OH, United States.

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 (100mg/day) or placebo for 96weeks. Imaging is conducted every 24weeks 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 complete 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.

https://www.ncbi.nlm.nih.gov/pubmed/27521810
MS Speaks--online for 17 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010. Glatopa (glatiramer acetate 40mg 3 times/week) since 12/16/20.

 

Related Topics

  Subject / Started by Replies Last post
1 Replies
211 Views
Last post November 14, 2018, 04:04:14 pm
by agate
0 Replies
60 Views
Last post February 02, 2019, 03:59:52 pm
by agate
0 Replies
60 Views
Last post March 21, 2019, 04:33:52 pm
by agate
0 Replies
62 Views
Last post April 04, 2019, 04:14:29 pm
by agate
0 Replies
14 Views
Last post April 18, 2023, 09:42:30 pm
by agate