Radiation-induced XerostomiaNCT05060341
Long-Term Follow-Up Study of AAV2hAQP1 for Radiation Induced Xerostomia
An observational study of Radiation-induced Xerostomia, run by MeiraGTx, LLC at 4 sites in 2 countries.
Trial summary
This study is a long-term follow-up study for patients who have been administered AAV2hAQP1 in the Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity in Subjects with Radiation Induced Parotid Gland Hypofunction and Xerostomia Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Radiation-induced Xerostomia
- How many people
- 22 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 12 Nov 2020to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 81 years
- All sexes
- Adult, Older adult
Study population: Subjects with radiation induced parotid gland hypofunction and xerostomia who have particpated in the MGT016 AAV2hAQP1 study.
Who may be able to join
- Are willing and able to provide informed consent
- Received AAV2hAQP1 administered via Stensen's duct to a single or both parotid glands in the prior open-label, Phase 1, dose-escalation study (Study MGT016)
- Are willing and able to adhere to the protocol and long-term follow-up
Who cannot join
- 1. Subjects unwilling or unable to meet with the requirements of the study will be excluded
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02184
Atrium Health
Charlotte, North Carolina, 28209
Leland Stanford Junior University
Stanford, California, 94305
Canada1 site
Health Sciences North - Northeast Cancer Center
Greater Sudbury, Ontario
About this study
Official title: Long-Term Follow-Up Study of Participants Enrolled in the MGT016 Phase 1, Open-Label, Dose-Escalation Study of AAV2hAQP1 for Radiation-Induced Parotid Gland Hypofunction and Xerostomia
This study is a long-term follow-up study for patients who have been administered AAV2hAQP1 in the Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity in Subjects with Radiation Induced Parotid Gland Hypofunction and Xerostomia
Read the detailed description
This clinical trial is designed to assess the long-term safety and activity of intra-parotid administration of AAV2hAQP1 in subjects with radiation-induced parotid salivary hypofunction and xerostomia.
After completion of their Month 12 Follow-Up visit in Study MGT016, subjects will be invited to enroll in this 4-year follow-up study during which they will be assessed for up to 60 months following study drug administration. This follow-up trial is a non-interventional study designed to collect data on longer-term safety and activity at 18, 24, 36, 48, and 60 months following study drug administration.
Over the course of the study, subjects will undergo physical and oral examinations; vital sign measurements; weight measurements; AE assessments; concurrent medication assessments; sample blood collection for hematology and chemistry; urinalysis; ear, nose, and throat (ENT) screening for malignancy; imaging assessments (if indicated); salivary flow assessments; and questionnaire assessments.
- Conditions
- Radiation-induced Xerostomia
What is being measured
The primary outcome is the main question the study is designed to answer.
• Incidence of AEs, treatment-emergent adverse events (TEAEs), and SAEs
Safety
Measured: 4 years
Secondary outcomes (4)
Changes in saliva flow compared to baseline.
Changes in unstimulated and stimulated salivary output (mL/minute) of the treated parotid gland and/or whole saliva output as compared to baseline.
Measured: 4 years
Changes in the McMaster Global Rate of Change relative to Baseline
This first part of this questionnaire asks the patient to evaluate their Dry Mouth relative to before treatment as better, worse, or the same. If better or worse, the patient is asked to rate the magnitude of change, on a scale of 1-7, with a higher score being a better outcome.
This first part of this questionnaire asks the patient to evaluate how limited they are in daily activities due to dry mouth, relative to before treatment as better, worse, or the same. If better or worse, the patient is asked to rate the magnitude of change, on a scale of 1-7, with a higher score being a better outcome.
Measured: 4 years
Changes in the Xerostomia Questionnaire relative to Baseline
The XQ is a series of 8 questions designed to assess the degree of xerostomia symptoms. Each question is a scale of 1-10, with high values indicating worse xerostomia.
Measured: 4 years
Changes in the MD Anderson Symptom Inventory - Head and Neck
The MDASI-HN is a questionnaire consisting of 28 questions designed to assess the degree of xerostomia symptoms. Each question is a scale of 1-10, with high values indicating worse xerostomia.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start12 Nov 2020
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-induced XerostomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- MeiraGTx, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060341
- Sponsor's protocol ID
- MGT-AQP1-102
- Status last verified
- Jul 2026
- First submitted
- 9 Mar 2021
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-Up Study of Participants Enrolled in the MGT016 Phase 1, Open-Label, Dose-Escalation Study of AAV2hAQP1 for Radiation-Induced Parotid Gland Hypofunction and Xerostomia
- ClinicalTrials.gov ID
- NCT05060341
- Acronym / sponsor ID
- MGT-AQP1-102
- Conditions
- Radiation-induced Xerostomia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- MeiraGTx, LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a long-term follow-up study for patients who have been administered AAV2hAQP1 in the Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity in Subjects with Radiation Induced Parotid Gland Hypofunction and Xerostomia
Detailed description
This clinical trial is designed to assess the long-term safety and activity of intra-parotid administration of AAV2hAQP1 in subjects with radiation-induced parotid salivary hypofunction and xerostomia.
After completion of their Month 12 Follow-Up visit in Study MGT016, subjects will be invited to enroll in this 4-year follow-up study during which they will be assessed for up to 60 months following study drug administration. This follow-up trial is a non-interventional study designed to collect data on longer-term safety and activity at 18, 24, 36, 48, and 60 months following study drug administration.
Over the course of the study, subjects will undergo physical and oral examinations; vital sign measurements; weight measurements; AE assessments; concurrent medication assessments; sample blood collection for hematology and chemistry; urinalysis; ear, nose, and throat (ENT) screening for malignancy; imaging assessments (if indicated); salivary flow assessments; and questionnaire assessments.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects with radiation induced parotid gland hypofunction and xerostomia who have particpated in the MGT016 AAV2hAQP1 study.
Key inclusion criteria (3 listed)
- Are willing and able to provide informed consent
- Received AAV2hAQP1 administered via Stensen's duct to a single or both parotid glands in the prior open-label, Phase 1, dose-escalation study (Study MGT016)
- Are willing and able to adhere to the protocol and long-term follow-up
Key exclusion criteria (1 listed)
- 1. Subjects unwilling or unable to meet with the requirements of the study will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
• Incidence of AEs, treatment-emergent adverse events (TEAEs), and SAEs
Time frame: 4 years
Safety
4 secondary outcomes
Changes in saliva flow compared to baseline.
Time frame: 4 years
Changes in the McMaster Global Rate of Change relative to Baseline
Time frame: 4 years
Changes in the Xerostomia Questionnaire relative to Baseline
Time frame: 4 years
Changes in the MD Anderson Symptom Inventory - Head and Neck
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Radiation-induced Xerostomia
RecruitingPhase 1/2
Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1
Radiation-Induced Xerostomia and Hyposalivation
RecruitingPhase 2
Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia
Head and Neck Cancer
Active, not recruitingPhase 3
Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia
Head And Neck Cancer
RecruitingObservational study
Screening of Biomarkers and Related Mechanisms for RIX
Xerostomia Due to Radiotherapy (Disorder)
Active, not recruitingPhase 2
A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation-induced Xerostomia, run by MeiraGTx, LLC at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Incidence of AEs, treatment-emergent adverse events (TEAEs), and SAEs (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.