Velma Langford

Dextromethorphan-Quinidine (Nuedexta) Improves Swallowing in Bulbar Onset ALS Patients with Pseudobulbar Affect - Pre-Post Observational Study in 86 ALS Patients (P4.4-019)

Natasha Saurin Shah, Kathryn Wright, Elena Bravver, Urvi Desai et autres

To present data on effect of DMq treatment on swallowing in 86 ALS patients treated for PBA.

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McGill University Single Item Quality-of-Life ( QoL ) Scale Compared with ALS Health- Related Quality-of-Life Likert Scales Including Breathing QoL Measurement (P1.4-024)

Benjamin Rix Brooks, Elena Bravver, William L. Bockenek, Scott S. Lindblom et autres

Describe properties of an array of Likert-based health-related quality-of-life measurements compared with the McGill University Single Item Quality-of-Life ( QoL ) scale.

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Stage of prolonged survival in ALS

Benjamin Rix Brooks, Elena Bravver, Velma Langford, William L. Bockenek et autres

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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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ALS Dashboard – Cognitive, Affect, Bulbar, Respiratory, Arm, Leg Staging Algorithm – Single Center Longitudinal Assessment (P4.458)

Benjamin Brooks, Elena Bravver, Urvi Desai, Mohammed Sanjak et autres

Assess Clinical Disease Trajectory with ‘ALS Dashboard” longitudinally to define differences in rate of clinical stage changes in different domains in 422 patients from 2013–2016 compared with two previous cohorts.

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Six-Minute Walk Test as a Measure of Walking Capacity in Ambulatory Individuals With Amyotrophic Lateral Sclerosis

Mohammed Sanjak, Velma Langford, Scott Holsten, Nigel Rozario et autres

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Respiratory muscle unloading (RMU) to treat dyspnea on exertion (DOE) in ambulatory patients with Amyotrophic Lateral Sclerosis (ambALS). (S43.004)

Mohammed Sanjak, Dillon C. Malloy, Scott Holsten, Velma Langford et autres

To determine the feasibility, tolerability, safety, and treatment effect size of RMU to treat DOE.

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Quantitative Labial, Tongue Speech and Swallowing Rate Measurements at Diagnosis Correlate with ALS Functional Rating Scale – Revised (ALSFRS-R) Bulbar Subscore and Bulbar Subscore Item Scores – Effect of Nuedexta on Speech and Swallowing (P3.132)

Kathryn Wright, Benjamin D. Brooks, Velma Langford, Elena Bravver et autres

Labial Articulation (Pepper)[LAR], Lingual Articulation(Ticker)[TAR] and Liquid Swallowing (90mL water) [LSR]rates were determined in 147 patients with other neuromuscular diseases and 118 patients with ALS and compared with 158 age-sex-matched control subjects.

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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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Amyotrophic Lateral Sclerosis (ALS) with Laboratory Abnormalities of Unknown Significance (LAUS) --Where Does It Begin and Where Does It End? (P4.144)

Benjamin Rix Brooks, Elena Bravver, Velma Langford, Mohamed Alwan et autres

OBJECTIVE: Define the prevalence/natural history of ALS-LAUS at an ALS Multidisciplinary Clinic in the Southeastern USA BACKGROUND: ALS-LAUS, characterized by upper and lower motor neuron signs together with LAUS, was categorized as a diagnostic classification category by the World Federation of Neurology …

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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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