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Gene Therapy
Gene Therapy for Radiation-Induced Dry Mouth (AQUAX2 Trial)
Phase 2
Recruiting
Research Sponsored by MeiraGTx, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
AQUAX2 Trial Summary
This trial studies how safe and effective a gene therapy is for treating dry mouth caused by radiation therapy.
Who is the study for?
Adults who've had radiation therapy for head and neck cancer at least 3 years ago, have a certain level of dry mouth severity, and can produce some saliva. They shouldn't have recurring or new cancers, be on specific medications affecting saliva, or have conditions like uncontrolled diabetes, recent smoking history, alcohol misuse, autoimmune diseases affecting salivary glands or certain infections.Check my eligibility
What is being tested?
The trial is testing two different doses of AAV2-hAQP1 gene therapy against a placebo to see if they can safely improve dry mouth caused by past radiation treatments. Participants will receive the treatment directly into their parotid gland (a major salivary gland).See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include reactions at the injection site such as pain or swelling, immune responses to the viral vector used in gene therapy (like fever), and possible unintended effects on saliva production.
AQUAX2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline to Month 12 in Xerostomia-specific Questionnaire (XQ) Total Score
Secondary outcome measures
Change from Baseline to Month 12 in unstimulated whole saliva flow rate
Number of participants with treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
AQUAX2 Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: AAV2-hAQP1 Group 2Experimental Treatment1 Intervention
Eligible participants will receive up to 3 mL of concentration 1 of AAV2-hAQP1 via Stensen's duct to each parotid gland
Group II: AAV2-hAQP1 Group 1Experimental Treatment1 Intervention
Eligible participants will receive up to 3 mL of concentration 1 of AAV2-hAQP1 via Stensen's duct to each parotid gland
Group III: Placebo groupPlacebo Group1 Intervention
Eligible participants will receive up to 3 mL of diluent via Stensen's duct to each parotid gland
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Who is running the clinical trial?
MeiraGTx, LLCLead Sponsor
4 Previous Clinical Trials
67 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune disease like Sjogren's that affects my salivary glands.I am currently using or have recently used medication that weakens my immune system.I have been diagnosed with myasthenia gravis.I chose to stop or not start prescribed medication for dry mouth.I currently have an active Epstein-Barr virus infection.I or my family have a history of glaucoma, or I'm at risk for it.My diabetes is not well-managed (A1c > 7%).I don't have head or neck cancer based on recent exams and scans.I finished radiation therapy for head or neck cancer over 3 years ago.I have stopped taking pilocarpine or cevimeline 2 weeks before screening and can avoid them during the study.I have smoked or used tobacco products within the last 3 years.I've been on a stable dose of medication that affects my saliva production for at least a month.I haven't had cancer in the last 3 years, except for certain skin cancers or cervical cancer that stayed in place.I have never had cancer in my salivary glands, recurring cancer, or a different type of cancer.My saliva flow rate is within the normal range after chewing.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo group
- Group 2: AAV2-hAQP1 Group 2
- Group 3: AAV2-hAQP1 Group 1
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How hazardous is the AAV2-hAQP1 Group 1 protocol for human health?
"Our team's analysis of AAV2-hAQP1 Group 1 has resulted in a hazard rating of 2 due to limited evidence that confirms its safety, but no data proving the efficacy."
Answered by AI
Are there any open slots for participants in this research study?
"Affirmative. As seen on clinicaltrials.gov, the trial which was initially posted June 13th 2023 is actively seeking participants. The study requires 120 individuals at a single site to partake in it."
Answered by AI
What is the upper limit on participant numbers for this experiment?
"Affirmative. Per the clinicaltrials.gov website, this scientific study is currently recruiting. The trial was initially posted on June 13th 2023 and updated most recently on June 22nd 2023. This experiment seeks 120 participants from a single site."
Answered by AI
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