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Study Protocol 7 Title: Role of Neurogenic Inflammation and Topical 6% Gabapentin Therapy in Symptomatic Scarring Alopecia Protocol Number: 1308M40801 Study Drug: Gabapentin 6% Solution Principal Investigator: Maria Hordinsky, MD 612-625-8625 Study Team: Rehana Ahmed-Saucedo, MD, PhD Margareth Pierre-Louis, MD Elisabeth Hurliman, MD, PhD Trial Site: University of Minnesota, Department of Dermatology MMC 98 Minneapolis, MN 55455 Laboratory: University of Minnesota, Fairview Laboratory 516 Delaware St. Minneapolis, MN 55455 Masonic Clinical Research Unit MMC 405, 420 Delaware St. Minneapolis, MN 55455 Version Date: January 12, 2016 CONFIDENTIAL This is a University of Minnesota clinical research trial document that contains confidential information. It is intended solely for the recipient clinical investigator(s) and must not be disclosed to any other party. The material may be used only for evaluating or conducting clinical investigations; any other proposed use requires written consent from the University of Minnesota Department of Dermatology. Scarring Alopecia-Gabapentin Study Version 5 | Approved 01.28.2016 Page ii Table of Contents STUDY SUMMARY ................................................................................................................................. 1 1 INTRODUCTION ............................................................................................................................... 2 1.1 BACKGROUND .............................................................................................................................. 2 1.2 INVESTIGATIONAL AGENT............................................................................................................... 2 1.3 PRECLINICAL DATA ....................................................................................................................... 3 1.4 CLINICAL DATA TO DATE ............................................................................................................... 3 1.5 DOSE RATIONALE AND RISK/BENEFITS ............................................................................................ 3 2 STUDY OBJECTIVES ....................................................................................................................... 4 3 STUDY DESIGN ............................................................................................................................... 4 3.1 GENERAL DESIGN ......................................................................................................................... 4 3.2 PRIMARY STUDY ENDPOINTS ......................................................................................................... 5 3.3 SECONDARY STUDY ENDPOINTS .................................................................................................... 6 3.4 PRIMARY SAFETY ENDPOINTS ........................................................................................................ 6 4 SUBJECT SELECTION AND WITHDRAWAL ................................................................................... 6 4.1 INCLUSION CRITERIA ..................................................................................................................... 6 4.2 EXCLUSION CRITERIA .................................................................................................................... 6 4.3 SUBJECT RECRUITMENT AND SCREENING ....................................................................................... 7 4.4 EARLY WITHDRAWAL OF SUBJECTS ................................................................................................ 7 4.4.1 When and How to Withdraw Subjects .................................................................................. 7 4.4.2 Data Collection and Follow-up for Withdrawn Subjects ........................................................ 8 5 STUDY DRUG................................................................................................................................... 8 5.1 DESCRIPTION ............................................................................................................................... 8 5.2 METHOD FOR ASSIGNING SUBJECTS TO TREATMENT GROUPS ........................................................... 9 5.3 PREPARATION AND ADMINISTRATION OF STUDY DRUG ...................................................................... 9 5.4 SUBJECT COMPLIANCE MONITORING .............................................................................................. 9 5.5 PRIOR AND CONCOMITANT THERAPY .............................................................................................. 9 5.6 PACKAGING ................................................................................................................................. 9 5.7 BLINDING OF STUDY DRUG ............................................................................................................ 9 5.8 RECEIVING, STORAGE, DISPENSING AND RETURN ............................................................................ 9 5.8.1 Receipt of Drug Supplies ................................................................................................... 10 5.8.2 Dispensing of Study Drug .................................................................................................. 10 5.8.3 Return or Destruction of Study Drug .................................................................................. 10 6 STUDY PROCEDURES .................................................................................................................. 10 6.1 VISIT 1 (SCREENING/BASELINE) .................................................................................................... 10 6.2 VISIT 2 (DAY 0) ........................................................................................................................... 11 6.3 VISIT 3 (WEEK 4) ........................................................................................................................ 11 6.4 VISIT 4 (WEEK 8) ........................................................................................................................ 12 6.5 VISIT 5 (WEEK 12) ...................................................................................................................... 12 6.6 VISIT 6 (2 WEEK FOLLOW-UP) ....................................................................................................... 12 7 STATISTICAL PLAN ...................................................................................................................... 13 7.1 SAMPLE SIZE DETERMINATION ..................................................................................................... 13 7.2 STATISTICAL METHODS ............................................................................................................... 13 7.3 SUBJECT POPULATION(S) FOR ANALYSIS....................................................................................... 13 8 SAFETY AND ADVERSE EVENTS ................................................................................................. 13 8.1 DEFINITIONS .............................................................................................................................. 13 8.2 RECORDING OF ADVERSE EVENTS ............................................................................................... 15 8.3 REPORTING OF SERIOUS ADVERSE EVENTS .................................................................................. 15 8.3.1 Study Sponsor Notification by Investigator ......................................................................... 15 CONFIDENTIAL This material is the property of the University of Minnesota. Do not disclose or use except as authorized in writing by the study sponsor Page iii 8.3.2 IRB Notification by Investigator .......................................................................................... 16 8.3.3 FDA Notification by Sponsor .............................................................................................. 16 8.4 UNBLINDING PROCEDURES .......................................................................................................... 16 8.5 STOPPING RULES ....................................................................................................................... 16 8.6 MEDICAL MONITORING ................................................................................................................ 16 9 DATA HANDLING AND RECORD KEEPING ................................................................................. 17 9.1 CONFIDENTIALITY ....................................................................................................................... 17 9.2 SOURCE DOCUMENTS/CASE REPORT FORMS ................................................................................ 17 9.3 RECORDS RETENTION ................................................................................................................. 17 10 STUDY AUDITING, AND INSPECTING ........................................................................................ 17 10.1 AUDITING AND INSPECTING ........................................................................................................ 17 11 ETHICAL CONSIDERATIONS ...................................................................................................... 18 12 STUDY FINANCES ....................................................................................................................... 18 12.1 FUNDING SOURCE ...................................................................................................................
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