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Virus Therapy

Active treatment group for Dry Mouth

Phase 2
Waitlist Available
Research Sponsored by MeiraGTx, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Received study drug in Study MGT-AQP1-201
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study start until month 60 post-treatment
Awards & highlights

Summary

This study will assess the long-term safety and efficacy of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.

Who is the study for?
This trial is for adults with moderate to severe dry mouth (Grade 2 or Grade 3) caused by radiation therapy. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be excluded based on factors that could impact the study's results.
What is being tested?
The trial is testing a gene therapy called AAV2-hAQP1, which is administered into both parotid salivary glands. The goal is to evaluate the long-term safety and effectiveness of this treatment in reducing symptoms of dry mouth following radiation.
What are the potential side effects?
Potential side effects are not listed, but gene therapies like AAV2-hAQP1 can sometimes cause immune reactions, swelling at the injection site, changes in saliva production or taste, and other unforeseen issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study start until month 60 post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from study start until month 60 post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with study drug-related adverse events and serious adverse events

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Active treatment groupExperimental Treatment1 Intervention
Participants who were randomized to placebo treatment in Study MGT-AQP1-201, will be offered to transition from the long-term follow-up schedule to an active treatment schedule at the time of unblinding. Study drug administration should be completed after unblinding and after confirmation of the participant's continued eligibility for treatment. Upon completion of the 12-month primary treatment period, participants will continue in the study according to a follow-up schedule, to complete a total of 60 months of follow-up after AAV2-hAQP1 administration.
Group II: Follow-up groupActive Control1 Intervention
Participants who were randomized to AAV2-hAQP1 treatment in Study MGT-AQP1-201 will continue in this long-term follow-up schedule to complete an additional 48 months of follow-up after their end-of-study visit in Study MGT-AQP1-201. All study participants are to be followed for a period of 60 months after vector administration.

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Who is running the clinical trial?

MeiraGTx, LLCLead Sponsor
5 Previous Clinical Trials
187 Total Patients Enrolled
~80 spots leftby Feb 2031
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