NCT05060341

Active Not Recruiting

Long-Term Follow-Up Study of AAV2hAQP1 for Radiation Induced...

MeiraGTx, LLC Source

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Other study identifiers

Sponsor study identifier

MGT-AQP1-102

Study Type

observational

Actual enrollment (reported)

22

Locations

2 countries

Sites

4

Timeline

Study Start

November 12, 2020

Actual (reported)

Primary Completion

March 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

March 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Brief 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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: active not recruiting
Actual enrollment (reported): 22 participants
Study completion date: March 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 2 countries · 4 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 12, 2020
Actual (reported)
First Submitted
March 9, 2021
Actual (reported)
First Posted
September 29, 2021
Actual (reported)
Primary Completion
March 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: July 22, 2026
Status Verified: July 2026
Last Update Submitted: July 21, 2026

Conditions

Radiation-induced Xerostomia

Outcome Measures

Primary Outcomes (1)

• Incidence of AEs, treatment-emergent adverse events (TEAEs), and SAEs
Safety
4 years

Secondary Outcomes (4)

Changes in saliva flow compared to baseline.
4 years
Changes in the McMaster Global Rate of Change relative to Baseline
4 years
Changes in the Xerostomia Questionnaire relative to Baseline
4 years
Changes in the MD Anderson Symptom Inventory - Head and Neck
4 years

Eligibility Criteria

Age18 Years - 81 Years

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Subjects with radiation induced parotid gland hypofunction and xerostomia who have particpated in the MGT016 AAV2hAQP1 study.

You may qualify if:

Are willing and able to provide informed consent

Sponsors & Collaborators

MeiraGTx, LLC
Industrylead

Study Sites (4)

Leland Stanford Junior University

Stanford, California, 94305, United States

Brigham and Women's Hospital

Boston, Massachusetts, 02184, United States

Atrium Health

Charlotte, North Carolina, 28209, United States

Health Sciences North - Northeast Cancer Center

Greater Sudbury, Ontario, Canada

Enrollment

22 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: OTHER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 9, 2021

First Posted

September 29, 2021

Study Start

November 12, 2020

Actual (reported)

NCT00682747

Hyperbaric Oxygen for the Treatment of a Dry Mouth Which Occurred After Radiotherapy

Phase 2Terminated

NCT07431645

Pilot Study of Radiation-Induced Xerostomia Treatment With Allogeneic Mesenchymal Stromal Stem Cells

Phase 1Completed

NCT05020067

Impact on Xerostomia for Nasopharyngeal Carcinoma Patients Treated With or Without Superficial Parotid Lobe-sparing Intensity-modulated Radiotherapy

Phase 2Completed

NCT02589938

Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer

Not ApplicableCompleted

NCT03035825

Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients

Not ApplicableCompleted

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

You may not qualify if:

\. Subjects unwilling or unable to meet with the requirements of the study will be excluded

Contact the study team to confirm eligibility.

Primary Completion

March 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

March 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

July 22, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05060341
Data provider: ClinicalTrials.gov
Source updated: 2026-07-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:30 UTC

Locations

CA(1)US(3)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations