NCT05926765 · MeiraGTx, LLC
A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
(AQUAx2)
What this study is about
This study will assess the effectiveness and safety of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.
View original scientific description
This study will assess the efficacy and safety of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.
Interventions
GENETIC
AAV2-hAQP1 Concentration 1
Administration of concentration 1 of AAV2-hAQP1 via Stensen's duct to each parotid gland
GENETIC
AAV2-hAQP1 Concentration 2
Administration of concentration 2 of AAV2-hAQP1 via Stensen's duct to each parotid gland
OTHER
Placebo
Administration of diluent via Stensen's duct to each parotid gland
GENETIC
AAV2-hAQP1 Concentration 3
Administration of concentration 3 of AAV2-hAQP1 via Stensen's duct to each parotid gland
GENETIC
AAV2-hAQP1 Concentration 4
Administration of concentration 4 of AAV2-hAQP1 via Stensen's duct to each parotid gland
Primary outcome measures
Change from Baseline to Month 12 in Xerostomia-specific Questionnaire (XQ) Total Score
Time frame: 12 months
The XQ consists of 8 symptom-specific questions the participant rates from 0 (not present) to 10 (worst possible). The XQ Total Score is the sum of all individual item ratings and ranges from 0 to 80.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Completed beam radiation therapy for head and neck cancer at least 3 years prior to the first screening visit
- No history of recurrent head and neck cancer, parotid gland cancer, or a second primary cancer, except for treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma
- An unstimulated whole saliva flow rate (mL/min) \>0 (i.e., at least one drop of saliva in the collection tube)
- A stimulated whole saliva flow rate (mL/min) within a specified range after mechanical stimulation by chewing
- Average screening XQ Total Score at or above a specified threshold
- No evidence of head and neck cancer, defined as a negative otolaryngology exam and a negative computed tomography (CT) scan of the head, neck, and chest with contrast. If a participant has had a magnetic resonance imaging (MRI) study, CT scan, positron emission tomography (PET), or fluorodeoxyglucose-positron emission tomography (FDG-PET) scan of the head, neck, and chest
Where
- Gilbert, Arizona
- Duarte, California
- Miami, Florida
- Iowa City, Iowa
- Baltimore, Maryland
- Boston, Massachusetts
- Detroit, Michigan
- Columbia, Missouri
- St Louis, Missouri
- Buffalo, New York
- Chapel Hill, North Carolina
- Charlotte, North Carolina
And 5 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 2, 2026 · Source of record for eligibility and locations