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Small Molecule

FX-322 for Sensorineural Hearing Loss

Phase 2
Waitlist Available
Research Sponsored by Frequency Therapeutics
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 day 90
Awards & highlights

Study Summary

This trial will test if a new drug, given as a single dose by injection into the ear, can improve hearing in adults with acquired SNHL.

Eligible Conditions
  • Sensorineural Hearing Loss
  • Noise-Induced Hearing Loss
  • Sudden Hearing Loss

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Word Recognition in Quiet
Secondary outcome measures
Patient Global Impression of Change (PGI-C) Daily Impacts Scale
Patient Global Impression of Change (PGI-C) Hearing Loss Scale
Standard Pure Tone Audiometry
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: FX-322Active Control1 Intervention
FX-322, 1 dose
Group II: PlaceboPlacebo Group1 Intervention
Placebo, 1 dose

Find a Location

Who is running the clinical trial?

Frequency TherapeuticsLead Sponsor
6 Previous Clinical Trials
194 Total Patients Enrolled
Carl LeBel, PhDStudy DirectorFrequency Therapeutics
15 Previous Clinical Trials
1,607 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA officially sanctioned FX-322?

"Our company's assessment of FX-322 safety is 2 based off its Phase 2 status. This suggests that there are some existing data points to support the drug's security, though none confirming efficacy as yet."

Answered by AI

Is enrollment for this trial currently open?

"At present, this clinical trial is not recruiting patients, as evidenced by the information on clinicaltrials.gov. Originally posted in October 12th 2021 and last updated two days later, 165 other trials are actively searching for participants."

Answered by AI

Is it possible to join this experiment?

"This medical trial is recruiting 142 participants, from the age of majority up to 65 years old, with sudden hearing loss. Females must possess non-childbearing potential and use two forms of reliable contraception or abstain during the study period; males should wear a condom equipped with spermicide while participating in this research or remain celibate. Participants need to demonstrate adequate communication skills and commit to completing all necessary procedures as specified by investigators. Furthermore, patients have to have acquired adult onset sensorineural hearing loss based on noise-induced SNHL (NIHL) or idiopathic sudden SNHL (SSNHL). Furthermore, they must"

Answered by AI

Are adolescents eligible to participate in this research endeavor?

"Qualified individuals for this specific trial must be 18-65 years old. Conversely, 54 clinical trials are available to those under the age of majority and 129 studies offer support to seniors above 65 years old."

Answered by AI

How many physical facilities are involved in the management of this trial?

"Partaking in this trial is currently feasible at 25 medical sites, with Spartanburg, Amherst and Sarasota being some of the most notable. To reduce travel expenses while taking part in the study you should consider selecting a location closest to your home."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Florida
How old are they?
65+
18 - 65
What site did they apply to?
Clinical Trial Site
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Most responsive sites:
  1. Clinical Trial Site: < 24 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
Email
~41 spots leftby Apr 2025