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ICH Protocol Template CLINICAL STUDY PROTOCOL STUDY TITLE: Effect of Mexiletine on Cortical Hyperexcitability in Sporadic Amyotrophic Lateral Sclerosis (SALS) STUDY DRUG: Mexiletine VERSION: 5.0 PROTOCOL DATE: July 10, 2017 PROTOCOL NUMBER: MX-ALS-002 The information contained herein is confidential and proprietary in nature, and will not be disclosed to any third party without written approval of NEALS or its authorized designee. This document may be disclosed to the appropriate institutional review boards under the condition that they maintain confidentiality. Mexiletine 2 Protocol: Version 5.0 Date: July 10, 2017 STATEMENT OF COMPLIANCE This study will be conducted in compliance with the protocol, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP), and the applicable regulatory requirements, United States Code of Federal Regulations (CFR) Title 45 CFR Part 46 and Title 21 CFR Parts 50, 56, and 312. CONFIDENTIAL INFORMATION 2 Mexiletine 2 Protocol: Version 5.0 Date: July 10, 2017 SIGNATURE PAGE I have read the attached protocol entitled, “Effect of Mexiletine on Cortical Hyperexcitability in Sporadic Amyotrophic Lateral Sclerosis (SALS)” dated July 10, 2017 (Version 5.0) and agree to abide by all described protocol procedures. I agree to comply with the International Conference on Harmonisation Tripartite Guideline on Good Clinical Practice, applicable regulations and guidelines, local Institutional Review Board (IRB) guidelines and policies, and the Health Insurance Portability and Accountability Act (HIPAA). Site Investigator (Print Name):___________________________________________________ Signature: Date: CONFIDENTIAL INFORMATION 3 Mexiletine 2 Protocol: Version 5.0 Date: July 10, 2017 TABLE OF CONTENTS STATEMENT OF COMPLIANCE ........................................................................................................................... 2 SIGNATURE PAGE ................................................................................................................................................... 3 TABLE OF CONTENTS ............................................................................................................................................ 4 LIST OF ABBREVIATIONS ..................................................................................................................................... 8 PROTOCOL SUMMARY ........................................................................................................................................ 10 SCHEDULE OF EVENTS AND STUDY WORKFLOW ..................................................................................... 13 TABLE 1. SCHEDULE OF EVENTS ............................................................................................................................. 13 1.0. ETHICS........................................................................................................................................................ 16 1.1. INDEPENDENT ETHICS COMMITTEE (IEC) OR INSTITUTIONAL REVIEW BOARD (IRB) .............................. 16 1.2. ETHICAL CONDUCT OF STUDY .................................................................................................................. 16 1.3. SUBJECT INFORMATION AND CONSENT ..................................................................................................... 16 2.0. INTRODUCTION ....................................................................................................................................... 17 2.1. BACKGROUND AND SIGNIFICANCE ............................................................................................................ 17 2.1.1. Clinical Features and Epidemiology of ALS ..................................................................................... 17 2.1.2. Overview of ALS Pathogenesis ........................................................................................................... 17 2.1.3. Mexiletine in Neurological Disorders ................................................................................................ 18 2.1.3.1. The Neuroprotective Properties of Mexiletine in Animal Models............................................ 18 2.1.3.2. Experience with Mexiletine in Neurologic Disease .................................................................... 19 2.1.4. Rationale for Choosing Mexiletine in ALS ........................................................................................ 22 2.1.5. Experimental Therapeutics in ALS .................................................................................................... 23 2.1.6. Significance ........................................................................................................................................ 23 2.2. MEXILETINE .............................................................................................................................................. 23 2.2.1. Pharmacokinetics ............................................................................................................................... 23 2.2.1.1. Absorption, Distribution, Elimination and Metabolism ........................................................... 23 2.2.2. Drug Interactions ................................................................................................................................ 24 2.2.3. Mexiletine Adverse Effects ................................................................................................................. 25 2.2.4. Selection of Dosage in the Study ........................................................................................................ 30 2.3 OTHER POTENTIAL RISKS AND BENEFITS ....................................................................................................... 30 2.3.1 Potential Risks .................................................................................................................................... 30 2.3.2. Potential Benefits ................................................................................................................................ 31 3.0. STUDY OBJECTIVES ............................................................................................................................... 32 3.1. PRIMARY ................................................................................................................................................... 32 3.2. SECONDARY .............................................................................................................................................. 32 4.0. STUDY DESIGN ......................................................................................................................................... 33 4.1. OVERALL STUDY DESIGN AND PLAN ........................................................................................................ 33 4.2 INFORMED CONSENT ................................................................................................................................. 33 4.3. STUDY CENTERS ....................................................................................................................................... 34 4.4. STUDY DURATION ..................................................................................................................................... 34 4.5. PROTOCOL ADHERENCE ............................................................................................................................ 34 5.0. STUDY ENROLLEMENT AND WITHDRAWAL ................................................................................. 35 5.1. NUMBER OF STUDY SUBJECTS................................................................................................................... 35 5.2. Inclusion and Exclusion Criteria ....................................................................................................... 35 5.2.2. Exclusion Criteria .......................................................................................................................... 35 5.3. RE-SCREENING .......................................................................................................................................... 36 CONFIDENTIAL INFORMATION 4 Mexiletine 2 Protocol: Version 5.0 Date: July 10, 2017 5.4 RANDOMIZATION PROCEDURES ................................................................................................................ 36 5.5. REASONS FOR WITHDRAWAL .................................................................................................................... 36 5.6. HANDLING OF WITHDRAWALS .................................................................................................................. 37 5.7. TERMINATION OF STUDY ........................................................................................................................... 37 6.0. TREATMENT OF SUBJECTS ................................................................................................................. 39 6.1. TREATMENTS ............................................................................................................................................ 39 6.1.1. Mexitil ................................................................................................................................................. 39 6.1.2. Placebo ...............................................................................................................................................
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