Boston, MANCT07627971Now EnrollingIRB Ready

GJB2-mediated Hearing Loss Clinical Trial in Boston, MA

Access cutting-edge gjb2-mediated hearing loss treatment through this clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by Skylark Bio Inc.

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Expert Care in Boston

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related gjb2-mediated hearing loss treatment provided free

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Check if you qualify for this gjb2-mediated hearing loss clinical trial in Boston, MA

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Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Boston site if eligible
  4. 4Begin participation

About This GJB2-mediated Hearing Loss Study in Boston

Skylark Bio is conducting a study of an investigational new drug called SKY-GJB2 and its delivery device, the SKY-CAT. SKY-GJB2 is a gene therapy that is being developed to treat children who have hearing loss due to changes in the GJB2 gene (also referred to as Connexin 26). The SKY-CAT is a device that delivers the gene therapy. The purpose of this study is to: Learn about the safety and tolerability (does not cause ongoing discomfort) of SKY-GJB2 Evaluate the efficacy of SKY-GJB2 (how well is works)

Sponsor: Skylark Bio Inc.

Who Can Participate

Inclusion Criteria

Male or female aged 9 months to 7 years at the time of gene therapy administration
Subjects must have at least two (biallelic) pathogenic or likely pathogenic variants in the GJB2 gene
Bilateral sensorineural hearing loss as assessed by ABR. Hearing loss at ≥85 dB HL for at least one of the frequencies (500-4000 Hz) in the study treatment ear.
Subject's parent(s)/guardian(s) provide informed consent before the initiation of study-related procedures.
Subject is able and willing to comply (or provide assent if old enough) will all study requirements.

Exclusion Criteria

Subject has non-GJB2 mediated hearing loss including genetic, syndromic, or non-syndromic hearing loss that is not associated with GJB2 mutations.
Subject has autosomal dominant nonsyndromic hearing loss due to GJB2 mutation.
No response on ABR testing.
Bilateral Cochlear Implants.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT07627971) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

GJB2-mediated Hearing Loss Treatment Options in Boston, MA

If you're searching for gjb2-mediated hearing loss treatment options in Boston, MA, this clinical trial (NCT07627971) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced gjb2-mediated hearing loss specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all gjb2-mediated hearing loss clinical trials near you to find additional studies recruiting in your area.

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