Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-22-120
Prinicipal Investigator
Goyal, Neerav
Phase
Phase II
Age Group
Adult
Scope
National
Secondary Protocol No.
MGT-AQP1-201 ( MeiraGTx)
Title
A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of AAV2-hAQP1 Gene Therapy in Participants with Radiation-Induced Late Xerostomia (RIX)
Objective
Primary Objectives: To assess the effect of bilateral treatment with AAV2-hAQP1 on xerostomia-related symptoms as measured by the Xerostomia-specific Questionnaire (XQ).
Key Secondary Objectives: To assess the effect of bilateral treatment with AAV2-hAQP1 on unstimulated whole saliva output (mL/min), To evaluate the safety and tolerability of bilateral treatment with AAV2-hAQP1.
Applicable Disease Sites
Head and Neck
Status
Open
Participating Institutions
Hershey Medical Center