Page last updated: 2024-10-28

ibudilast and Bilateral Headache

ibudilast has been researched along with Bilateral Headache in 2 studies

Research Excerpts

ExcerptRelevanceReference
"In a phase 2 trial involving patients with progressive multiple sclerosis, ibudilast was associated with slower progression of brain atrophy than placebo but was associated with higher rates of gastrointestinal side effects, headache, and depression."5.27Phase 2 Trial of Ibudilast in Progressive Multiple Sclerosis. ( Alvarez, E; Apperson, M; Ashokkumar, A; Barnes, J; Bashir, K; Bermel, RA; Coffey, CS; Cohen, BA; Conwit, R; Coyle, PK; Cudkowicz, ME; Debbins, JP; Delgado, S; Dewitt, LD; Ecklund, D; Flores, A; Fox, RJ; Giesser, BS; Gleason, T; Goldman, MD; Goodman, A; Huang, X; Jagodnik, P; Jubelt, B; Klawiter, EC; Klingner, E; Koepp, M; Krieger, S; Lava, N; Long, JD; Lowe, MJ; Lynch, SG; Matsuda, K; McGovern, M; Moses, H; Naismith, RT; Nakamura, K; Narayanan, S; Natarajan, S; Ontaneda, D; Perumal, JS; Racke, M; Repovic, P; Riley, CS; Sakaie, KE; Severson, C; Shinnar, S; Suski, V; Thoomukuntla, B; Thornell, B; Weinstock-Guttman, B; Yadav, V; Yankey, J; Zabeti, A; Zhou, X, 2018)

Research

Studies (2)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's1 (50.00)18.2507
2000's0 (0.00)29.6817
2010's1 (50.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Fox, RJ1
Coffey, CS1
Conwit, R1
Cudkowicz, ME1
Gleason, T1
Goodman, A1
Klawiter, EC1
Matsuda, K1
McGovern, M1
Naismith, RT1
Ashokkumar, A1
Barnes, J1
Ecklund, D1
Klingner, E1
Koepp, M1
Long, JD1
Natarajan, S1
Thornell, B1
Yankey, J1
Bermel, RA1
Debbins, JP1
Huang, X1
Jagodnik, P1
Lowe, MJ1
Nakamura, K1
Narayanan, S1
Sakaie, KE1
Thoomukuntla, B1
Zhou, X1
Krieger, S1
Alvarez, E1
Apperson, M1
Bashir, K1
Cohen, BA1
Coyle, PK1
Delgado, S1
Dewitt, LD1
Flores, A1
Giesser, BS1
Goldman, MD1
Jubelt, B1
Lava, N1
Lynch, SG1
Moses, H1
Ontaneda, D1
Perumal, JS1
Racke, M1
Repovic, P1
Riley, CS1
Severson, C1
Shinnar, S1
Suski, V1
Weinstock-Guttman, B1
Yadav, V1
Zabeti, A1
Shimomura, T1
Kowa, H1
Takahashi, K1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast (MN-166) in Subjects With Progressive Multiple Sclerosis[NCT01982942]Phase 2255 participants (Actual)Interventional2013-11-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Covariate-adjusted Mean Rate of Change in Brain Atrophy Over 96 Weeks as Measured by Brain Parenchymal Fraction (BPF).

To evaluate the activity of ibudilast (100 mg/day) versus placebo at 96 weeks as measured by quantitative magnetic resonance imaging (MRI) analysis for whole brain atrophy using brain parenchymal fraction (BPF), calculated as the ratio of brain parenchymal tissue volume to the total volume contained within the brain surface contour. (NCT01982942)
Timeframe: 96 weeks

Interventionratio (Mean)
Ibudilast-0.00168
Placebo Oral Capsule-0.00392

Magnetization Transfer Ratio (MTR) Imaging in Normal-appearing Brain Tissue

A magnetization transfer MRI as a marker of brain myelin content including the cerebral cortex could be useful. MT imaging provides access to the restricted protons, which are located in biologically interesting tissue regions.Cortical and normal appearing grey matter MTR correlates strongly with measures of disability such as the multiple sclerosis functional composite score and can show treatment effects. (NCT01982942)
Timeframe: 96 weeks

Interventionratio (Least Squares Mean)
Ibudilast0.325
Placebo Oral Capsule0.247

New T1 Lesions Since Baseline

New T1 lesions since baseline as measured by least square mean (90% confidence interval). (NCT01982942)
Timeframe: 96 weeks

Interventionlesions (Least Squares Mean)
Ibudilast0.355
Placebo Oral Capsule0.317

Percentage of Participants With Adverse Events.

Safety Measures: percentage of participants who experienced treatment-emergent adverse events, clinically significant abnormal laboratory and electrocardiogram results. (NCT01982942)
Timeframe: 96 weeks

Interventionpercentage receiving study medication (Number)
Ibudilast92.2
Placebo Oral Capsule88.1

Retinal Nerve Fiber Layer as Measured by Optical Coherence Tomography (OCT).

Mean retinal nerve fiber layer thickness from baseline measured by Optical coherence tomography (OCT), a non-invasive imaging technique used to obtain high-resolution cross-sectional images of the retina. Increase in thickness is considered improvement. (NCT01982942)
Timeframe: 96 weeks

Interventionmicrometers (Least Squares Mean)
Ibudilast83.0
Placebo Oral Capsule79.5

Diffusion Tensor Imaging (DTI) in Descending Pyramidal White Matter Tracts

Diffusion tensor imaging estimates the three-dimensional diffusion of water in brain tissue and has been explored as an outcome in MS. (NCT01982942)
Timeframe: 48 weeks

,
Intervention10^3/mm^2/s (Least Squares Mean)
Left axial diffusivity meanLeft radial diffusivity meanRight axial diffusivity meanRight radial diffusivity mean
Ibudilast0.0001-0.00770.0014-0.0029
Placebo Oral Capsule-0.00060.0027-0.00170.0046

Trials

1 trial available for ibudilast and Bilateral Headache

ArticleYear
Phase 2 Trial of Ibudilast in Progressive Multiple Sclerosis.
    The New England journal of medicine, 2018, 08-30, Volume: 379, Issue:9

    Topics: Adult; Atrophy; Brain; Depression; Diffusion Tensor Imaging; Disease Progression; Double-Blind Metho

2018

Other Studies

1 other study available for ibudilast and Bilateral Headache

ArticleYear
Analgesic-induced headaches: successful treatment with ibudilast.
    Headache, 1991, Volume: 31, Issue:7

    Topics: Adult; Analgesics; Female; Headache; Humans; Platelet Aggregation Inhibitors; Pyridines; Vasodilator

1991