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Statistical Analysis Plan STATISTICAL ANALYSIS PLAN A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Intranasal Midazolam (USL261) in the Outpatient Treatment of Subjects with Seizure Clusters ARTEMIS-1: Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray-1 Protocol Number P261-401 REDACTED COPY Upsher-Smith Laboratories, Inc. 6701 Evenstad Drive Maple Grove, MN 55369 Date of Plan: April 14, 2017 (Final v2.9) CONFIDENTIAL This document cannot be used to support any marketing authorization application and any extensions or variations thereof. STATISTICAL ANALYSIS PLAN Final 2.9 A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy oflntranasal M:idazolam (USL261) in the Outpatient Treatment of Subjects with Seizure Clusters ARTEMIS-1: Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray-1 APPROVAL SIGNATURES - Development Program Leader Upsher-Smith Laboratories, Inc. REDACTED COPY Biostatistics H20 Clinical, LLC This document cannot be used to support any marketing authorization application and any extensions or variations thereof. Upsher-Smith Laboratories, Inc. Statistical Analysis Plan for Protocol No.: P261-401 TABLE OF CONTENTS LIST OF ABBREVIATIONS......................................................................................................7 1. INTRODUCTION....................................................................................................8 2. STUDY DESIGN .....................................................................................................8 2.1. General Study Design and Plan.................................................................................8 2.1.1. Screening..................................................................................................................9 2.1.2. Test-Dose Phase .....................................................................................................10 2.1.3. Comparative Phase .................................................................................................10 2.2. Randomization and Method of Treatment Assignment............................................11 2.3. Study Procedures....................................................................................................12 3. STUDY OBJECTIVES...........................................................................................15 3.1. Primary Efficacy Objective.....................................................................................15 3.2. Secondary Efficacy Objectives ...............................................................................15 3.3. Exploratory Efficacy Objectives .............................................................................15 3.4. Safety Objectives....................................................................................................15 3.5. Pharmacokinetic Objectives....................................................................................16 4. ANALYSIS POPULATIONS.................................................................................16 4.1. Screened Population ...............................................................................................16 REDACTED COPY 4.2. Safety Population....................................................................................................16 4.3. Randomized Population..........................................................................................16 4.4. Randomized Safety Population ...............................................................................17 4.5. Modified Intent-to-Treat Population (mITT)...........................................................17 4.6. Per Protocol Population ..........................................................................................17 4.7. Pharmacokinetic Population....................................................................................17 5. GENERAL STATISTICAL CONSIDERATIONS .................................................18 5.1. Level of Significance..............................................................................................18 5.2. Handling of Missing Data.......................................................................................18 5.3. Interim Analyses.....................................................................................................19 5.3.1. Early Success..........................................................................................................19 5.3.2. Early Futility ..........................................................................................................20 5.3.3. Early Termination not related to Success or Futility................................................20 This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 5.3.4. Logistical details for interim analyses .....................................................................20 14 April 2017 3 Upsher-Smith Laboratories, Inc. Statistical Analysis Plan for Protocol No.: P261-401 5.4. Examination of Subgroups......................................................................................21 5.5. Data Collected from Unscheduled Visits.................................................................21 6. DESIGN OPERATING CHARACTERISTICS ......................................................21 6.1. Simulation Scenarios ..............................................................................................21 6.2. Operating Characteristics........................................................................................22 7. STATISTICAL ANALYSIS...................................................................................22 7.1. Subject Disposition.................................................................................................23 7.2. Protocol Deviations ................................................................................................23 7.3. Demographics and Baseline Characteristics ............................................................24 7.4. Medical and Surgical History..................................................................................24 7.5. Prior and Concomitant Medications ........................................................................25 7.6. Analyses of Efficacy Endpoints ..............................................................................26 7.6.1. Primary Efficacy Endpoint......................................................................................26 7.6.1.1. Derivation of Treatment Success Endpoint .............................................................27 7.6.1.2. Analysis of the Primary Endpoint ...........................................................................28 7.6.2. Secondary Efficacy Endpoints ................................................................................29 7.6.2.1. Proportion of Subjects with Recurrence of Seizure(s) Beginning 10 Minutes after Administration of Double-Blind Study Drug to 4 Hours after Double- Blind Study Drug Administration ...........................................................................29 REDACTED COPY 7.6.2.2. Time to Next Seizure with a Start Time >10 Minutes after Double-Blind Study Drug Administration.....................................................................................30 7.6.3. Exploratory Efficacy Analyses................................................................................30 7.6.3.1. Proportion of Subjects with Recurrence of Seizure(s) Beginning 10 Minutes after Study Drug Administration to 24 Hours after Study Drug Administration........................................................................................................30 7.6.3.2. Return to Full Baseline Functionality within 24 Hours after Study Drug Administration (as determined by the caregiver).....................................................31 7.6.3.3. Analyses for Subjects Receiving 2 Doses of Study Drug.........................................31 7.6.3.4. Treatment Success of all Dose of Study Drug .........................................................32 7.6.3.5. Subject and Caregiver Outcome Assessments .........................................................33 7.7. Safety Analyses ......................................................................................................34 7.7.1. Adverse Events (AEs).............................................................................................34 7.7.1.1. Pre-treatment AEs ..................................................................................................34 This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 7.7.1.2. Treatment-emergent AEs (TEAEs) .........................................................................34 14 April 2017 4 Upsher-Smith Laboratories, Inc. Statistical Analysis Plan for Protocol No.: P261-401 7.7.2. Observer’s Assessment of Alertness/Sedation (OAA/S)..........................................37 7.7.2.1. Composite Score.....................................................................................................37 7.7.2.2. Sum Score ..............................................................................................................37 7.7.2.3. Pharmacodynamic (PD) Parameters........................................................................37 7.7.3. Requirement for Unscheduled ER or EMS Visit .....................................................38
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