A Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia

Phase 3

Terminated

• Conditions: Herpes Zoster; Postherpetic Neuralgia; Shingles
• Interventions: Drug: FV-100; Drug: valacyclovir

• Registration Number: NCT02412917
• Lead Sponsor: ContraVir Pharmaceuticals, Inc.

Brief Summary

This is a multicenter, randomized, double-blind, parallel-group, active controlled comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes zoster).

Detailed Description

This is a multicenter, randomized, double-blind, parallel-group, active controlled comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes zoster). Subjects diagnosed with uncomplicated AHZ within 72 hours of lesion appearance and worst pain of 4 or greater at day 1, will be randomized (1:1:1) to one of three treatment groups and will begin study treatment at the Day 1 visit(within 72 hours of AHZ lesion appearance) to either: 1. FV-100 400mg QD, 2. FV-100 400mg BID(total daily dose of 800mg), or 3. Valacyclovir 1000mg 3 times a day for a total daily dose of 3000mg. Subjects will be monitored for adverse events through day 21. Efficacy assessments for lesion status and AHZ pain are captured til day 120.

Study Timeline

• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-04-06
• Study First Posted: 2015-04-09
• Study Start: 2015-06
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-20
• Last Update Posted: 2017-12-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 237

Inclusion Criteria

• Receive a clinical diagnosis of uncomplicated AHZ as evidenced by a unilateral dermatomal rash
• Have zoster-related pain
• Are able to be randomized and receive their first dose within approximately 120 hours from appearance of rash

Exclusion Criteria

• Have multidermal or disseminated AHZ
• Have facial, ophthalmologic or oral manifestations
• Have received Zostavax

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FV-100 400mg BID	FV-100	FV-100 400mg BID(total daily dose of 800mg)
FV-100 400 mg QD	FV-100	FV-100 400mg QD
valacyclovir	valacyclovir	valacyclovir 1000mg TID

Primary Outcome Measures

Name	Time	Method
The incidence of post-herpetic neuralgia(PHN) following treatment with 2 dose regimens of FV-100 compared to valacyclovir.	Day 1 to Day 120	efficacy measure

Secondary Outcome Measures

Name	Time	Method
Acute herpes zoster associated pain, as measured by Zoster Brief Pain Inventory(ZBPI)	Day 1 to Day 120	efficacy measure
The number and classification of adverse events in 2 dosing regimens of FV-100	Day 1 to Day 120	Safety measure
The pharmacokinetic profile of the active metabolite of FV-100 after 7 days of dosing at 400mg QD versus compared with 400mg BID	Day 1 to Day 120	Pharmacokinetic
The effect on lesion formation and healing of 2 dose regimens of FV-100 compared to valacyclovir	Day 1 to Day 120	efficacy measure

Trial Locations

Locations (1)

TX; 🇺🇸 Webster, Texas, United States