Joanna Dojillo

Ibudilast (MN-166) in amyotrophic lateral sclerosis- an open label, safety and pharmacodynamic trial

Suma Babu, Baileigh G. Hightower, James Chan, Nicole R. Zürcher et autres

Ibudilast (MN-166) is an inhibitor of macrophage migration inhibitory factor (MIF) and phosphodiesterases 3,4,10 and 11 (Gibson et al., 2006; Cho et al., 2010). Ibudilast attenuates CNS microglial activation and secretion of pro-inflammatory cytokines (Fujimoto et al., 1999; Cho et al., 2010). …

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Description of Protocol to Evaluate MN-001'S (tipelukast) Efficacy, Safety and Tolerability in Subjects with Idiopathic Pulmonary Fibrosis

Rebecca Bascom, Konrad Hitz, A.E.F. Dimmock, Malath Makhay et autres

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COMBAT-ALS Phase 2b/3 Trial of MN-166 (Ibudilast) in ALS: Study Design and Trial Update (5149)

Björn Oskarsson, Joanna Dojillo, Malath Makhay, Kazuko Matsuda

The primary objective of the study is to evaluate the efficacy of MN-166 on patient’s functional activity measured by ALSFRS-R score and survival in ALS subjects. The secondary objectives are to evaluate the efficacy on muscle strength measured by hand-held dynamometry, quality …

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Ibudilast - Phosphodiesterase Type 4 Inhibitor - Bi-Modal Therapy with Riluzole in Early [ Not Requiring Non-Invasive Ventilation ( NIV ) ] Cohort ( EC ) and Advanced [Requiring NIV ] ( ANC ) Amyotrophic Lateral Sclerosis ( ALS ) Patients - Single-Center Adaptive Design Six-Month Double-Blind ( DB ) - Placebo-Controlled Phase 1b/2a Epoch Followed by Six-Month Open Label Extension ( OLE ) Epoch, Washout ( WO ) and Post-Washout Epoch ( PWO ) – Final Report and Future Directions (P6.465)

Benjamin Brooks, Elena Bravver, Mohammed Sanjak, William L. Bockenek et autres

Report relationship of randomized DB-delayed-start/placebo-controlled ibudilast treatment combined with OLE treatment on clinical endpoint-responsiveness [ALSFRS-R total/sub/item scores, manual muscle strength measurements in limb/oro-facial muscles, vital capacity, maximal-inspiratory-pressure, maximal-voluntary-ventilation, bulbar/limb timed-functional-tests, quality-of-life measures, survival] at end of DB/OLE/WO epochs continuing into PWO epoch …

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Adaptive Design Single Center Phosphodiesterase Type 4 ( PDE4 ) Inhibitor – Ibudilast ( MN-166-ALS-1201 ) Phase 1b / 2a Clinical Trial Double - Blind ( DB ) with Open Label Extension (OLE) [ NCT02238626 ] for Amyotrophic Lateral Sclerosis ( ALS ) Patients [ 1 ] Not Requiring Non-Invasive Ventilation ( no NIV ) up to 5 years ( Early Cohort – EC ) and [ 2 ] Requiring Non-Invasive Ventilation ( NIV ) up to 10 years ( Advanced NIV Cohort – ANC ) from Disease Onset – Report of Clinical Trial DB, OLE and Post-Treatment Cessation Epochs – Per-Protocol (PP) Treatment Completion Associated with Improved Survival and Post Treatment Cessation Loss of Muscle Strength (P3.127)

Benjamin Rix Brooks, Elena Bravver, Mohammed Sanjak, Velma Langford et autres

Report on single center Ibudilast phase1b/2a clinical trial in ALS patients[1]no-NIV[EC] and [2]NIV[ANC]emphasizing safety/efficacy analysis of DB/OLE and post-treatment cessation epochs identifying that treatment completion is associated with improved, possibly enduring, survival and demonstration of post-treatment cessation loss of muscle strength in …

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Adaptive Design Single Center Phosphodiesterase Type 4 (PDE4) Inhibitor - Ibudilast (MN-166-ALS-1201) Phase 1b/2a Clinical Trial Double-Blind (DB) with Open Label Extensions (OLE) [ NCT02238626 ] for Amyotrophic Lateral Sclerosis (ALS) Patients [1] Not Requiring Non-Invasive Ventilation (no-NIV) up to 5 Years (Early Cohort-EC) and [2] Requiring Non-Invasive Ventilation (NIV) up to 10 Years(Advanced NIV Cohort-ANC) from Disease Onset - Behavior of Creatinine as a Biomarker in Short Clinical Trials (P5.003)

Benjamin Rix Brooks, Elena Bravver, Mohammed Sanjak, Velma Langford et autres

Objective: Report on implementation/results of adaptive design for single center Ibudilast phase 1b/2a clinical trial in ALS patients[1]not requiring non-invasive ventilation[EC] and[2]requiring non-invasive ventilation[ANC]. Background: Ibudilast, effective in two ALS gene based Drosophila models, has a known human safety profile that permits …

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A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Six-Month Clinical Trial Followed by an Open-Label Extension to Evaluate the Safety, Tolerability and Clinical Endpoint Responsiveness of the Phosphodiesterase Type 4 (PDE4) Inhibitor Ibudilast (MN-166) in Subjects with Amyotrophic Lateral Sclerosis (ALS) - STEP-IBUDILAST-ALS-DB-OLE-1 (S50.005)

Benjamin Rix Brooks, Elena Bravver, Mohammed Sanjak, Velma Langford et autres

OBJECTIVE: Ibudilast inhibiting PDE4(A)/PDE4(B)/PDE4(C)/PDE4(D) with IC50 values of 0.05μM/0.06μM/0.24μM/0.17 μM respectively, administered with Riluzole is safe/tolerable in ALS patients and improves ALS function and/or delays ALS progression. BACKGROUND: Vitamin E-promotes riluzole treatment by decreasing progression from early to middle stage of ALS(Desnuelle,2001)and …

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A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Six-Month Clinical Trial Followed by an Open-Label Extension to Evaluate the Safety, Tolerability and Clinical Endpoint Responsiveness of the Phosphodiesterase Type 4 (PDE4) Inhibitor Ibudilast (MN-166) in Subjects with Amyotrophic Lateral Sclerosis (ALS) - STEP-IBUDILAST-ALS-DB-OLE-1 (I8-1B)

Benjamin D. Brooks, Elena Bravver, Mohammed Sanjak, Velma Langford et autres

OBJECTIVE: Ibudilast inhibiting PDE4(A)/PDE4(B)/PDE4(C)/PDE4(D) with IC50 values of 0.05μM/0.06μM/0.24μM/0.17 μM respectively, administered with Riluzole is safe/tolerable in ALS patients and improves ALS function and/or delays ALS progression. BACKGROUND: Vitamin E-promotes riluzole treatment by decreasing progression from early to middle stage of ALS(Desnuelle,2001)and …

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