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Placebo for Hearing Loss

Phase 1

Waitlist Available

Research Sponsored by Decibel 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 0.25 hours predose, mid-point of iv infusion, end of infusion, 0.25, 0.5, 1 & 2 hours postdose on day 1 of each cycle (21 or 28 day cycles)

Awards & highlights

Study Summary

This trial will test whether DB-020 can prevent hearing loss in cancer patients receiving high doses of cisplatin.

Eligible Conditions

Hearing Loss
Ototoxicity

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening/baseline (day -28 to day -2) or day of first dose of db-020 (cycle 1 day 1) for up to 6 cycles (21 or 28 day cycles) through end of treatment visit (28 days after last dose of study drug), up to 196 days after first dose of study drug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening/baseline (day -28 to day -2) or day of first dose of db-020 (cycle 1 day 1) for up to 6 cycles (21 or 28 day cycles) through end of treatment visit (28 days after last dose of study drug), up to 196 days after first dose of study drug

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening/baseline (day -28 to day -2) or day of first dose of db-020 (cycle 1 day 1) for up to 6 cycles (21 or 28 day cycles) through end of treatment visit (28 days after last dose of study drug), up to 196 days after first dose of study drug for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients with treatment-emergent Adverse Events (TEAEs) and/or abnormal changes from baseline in clinical laboratory abnormalities and/or vital signs and/or ECG assessments

Secondary outcome measures

Area under the plasma concentration-time curve (AUC 0-inf) of free (unbound) cisplatin

Hearing

Changes from Baseline in Hearing Handicap Inventory for Adults (HHIA) Total Score compared to End of Treatment [Changes in Hearing]

+8 more

Trial Design

2Treatment groups

Active Control

Group I: DB-020 for Injection, 12%/placeboActive Control2 Interventions

dosage

Group II: DB-020 for Injection, 25%/placeboActive Control2 Interventions

dosage

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Decibel TherapeuticsLead Sponsor

2 Previous Clinical Trials

42 Total Patients Enrolled

2 Trials studying Hearing Loss

42 Patients Enrolled for Hearing Loss

Pablo LaPuertaStudy DirectorDecibel Therapeutics

John Keilty, MSStudy ChairDecibel Therapeutics

Frequently Asked Questions

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

How many individuals are enrolled in this experiment?

"This research is no longer enrolling patients; it was first posted on February 21st 2020 and has not been edited since July 27th 2022. Nonetheless, there are currently 12 trials looking for candidates with ototoxicity and 129 studies recruiting participants to test this treatment."

Answered by AI

To what extent can this treatment potentially be detrimental to a patient's health?

"Since this is a Phase 1 trial, representing the earliest stage of clinical trials and limited data supporting safety and efficacy, we conclude that it possesses a relatively low score in terms of safety."

Answered by AI

What medical conditions are typically managed with this therapeutic approach?

"This pharmaceutical is typically used to manage electrolyte balance, however it has been proven efficacious in treating facial deformities, hypochloremic states, and actinic keratosis."

Answered by AI

Are researchers still seeking participants for this research endeavor?

"Clinicaltrials.gov reveals that this particular medical trial, inaugurated on February 21st 2020 and last modified on July 27th 2022, is no longer recruiting. Nonetheless, there are presently 141 other trials actively searching for participants at this moment in time."

Answered by AI

What prior experiments have been conducted on this treatment regimen?

"Currently, 129 trials evaluating this therapeutic intervention are active with 31 in the late-stage Phase 3. Calgary houses a notable amount of these studies but there is also research being conducted across 433 locations worldwide."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment

2020. "Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04262336.