Noise-induced Hearing LossPhase 3NCT02903355

Phase 3 Clinical Trial: D-methionine to Reduce Noise-Induced Hearing Loss (NIHL)

A Phase 3 study testing D-methionine in people with Noise-induced Hearing Loss, run by Southern Illinois University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 21 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Noise-induced Hearing Loss
What is being tested?: D-methionine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 351 participants
Where: 1 siteUnited States
Study dates: Sep 2013to Dec 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female 21 to 45 years of age Negative pregnancy test at enrollment and prior to taking study drug Willing to use an effective method of birth control during the study (Both male and female participants should avoid pregnancy during study) Pure tone air conduction threshold average at 0.5, 1 and 2 kHz of no greater than 40 dB HL bilaterally with no air bone gaps greater than 10 dB and normal otoscopy and tympanometry screens Willing to refrain from using supplements containing or derived from protein while participating in this study Ability to comply with all study requirements

Who cannot join

History of allergic or idiosyncratic reaction to methionine, amino acid mixtures, nutritional supplements, egg white, or other proteins or food additives Vegetarian (Individual excludes meat and fish from their diet) History of chronic balance disorders Abnormal otoscopic findings, otologic surgery, autoimmune inner ear disease, significant air-bone gaps, abnormal tympanograms or other indication of middle-ear abnormality, history of fluctuant hearing or asymmetric hearing worse than 25 dB at any frequency in either ear, perilymphatic fistula, tumor of the auditory system, or other CNS disorder that is likely to affect hearing Treatment with intravenous (IV) antibiotics within the past 6 months Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug Treatment for alcohol or substance abuse within past 6 months Women of childbearing age who are not using effective contraceptive methods and who may become pregnant during the course of the study Women who are pregnant or breastfeeding. National Guardsmen History of psychotic schizophrenia Exposure within the previous 6 months to systemic ototoxic substances including aminoglycosides or vancomycin Body weight exceeding 225 pounds Renal impairment measured as eGFR < 50 on screening creatinine clearance blood draw.

Trial locations and contacts

1 site in 1 country.

United States1 site

Moncrief Army Community Hospital
Fort Jackson, South Carolina, 29207

Other trials in United States

About this study

This prospective study is a randomized, double-blind, placebo-controlled Phase 3 clinical trial of oral D-methionine (D-met) to reduce noise-induced hearing loss (NIHL) and tinnitus. The goal of the study is to develop a safe, oral pharmacological agent to augment physical hearing protectors for noise exposures that exceed the protective capabilities of ear plugs and/or muffs. The study population is a cohort of Drill Sergeant (DS) instructor trainees during and 22 days after their 11 day weapons training. The primary objective of this study is to determine the efficacy of D-met in preventing NIHL or reducing tinnitus secondary to a minimum of 500 rounds of M-16 weapons training occurring over an 11 day period.

Read the detailed description

Hearing loss can render a soldier less able to detect and identify the enemy, less able to understand commands, particularly in background noise typical on the battlefield, and may permanently reduce quality of life. In some cases, hearing loss may preclude redeployment or result in less optimal job assignment. Currently, no FDA approved pharmacological prevention exists for noise-induced hearing loss (NIHL). We have documented in animal studies that administration of D-methionine (D-met) can reduce or prevent NIHL. We now need to determine if it has similar efficacy in humans. Although we have not yet tested D-met on protection from noise-induced tinnitus in animals, this clinical trial would provide us the opportunity to also test for protection from noise induced tinnitus simultaneously.

Objective Hypotheses:

Primary Hypothesis: Administration of oral D-methionine prior to, during and 4 days post-weapons training will reduce or prevent permanent noise-induced hearing loss.

Secondary Hypothesis: Administration of oral D-methionine prior to, during and 4 days post-weapons training will reduce or prevent noise-induced tinnitus.

Specific Aims:

To determine whether administering oral D-met can prevent permanent NIHL after weapons training. This aim will be addressed by comparing the results of D-met versus placebo administration starting 3 days prior to, during the 11 day period of weapons training (Monday-Friday for first week, Monday-Thursday for second week), and 4 days after for a total of 18 days. Pure tone hearing thresholds will be assessed before and 22 days after completion of weapons training (ie; 18 days after the last day of study drug/placebo administration).

To determine whether administering oral D-met can prevent tinnitus after weapons training. This aim will be addressed by comparing the results of D-met versus placebo administration starting 3 days prior to, during the 11 day period of weapons training (Monday-Friday for first week, Monday-Thursday for second week), and 4 days after for a total of 18 days. Tinnitus questionnaires will be assessed before and 22 days after completion of weapons training (ie; 18 days after the last day of study drug/placebo administration).

To monitor for any potential side effects of D-met in human subjects. This aim will be accomplished by subject query on each day study drug is dispensed (twice daily) and at final study visit, routing of any adverse event reports to study medical personnel, statisticians and to the Food and Drug Administration (FDA).

Conditions: Noise-induced Hearing Loss
Being tested: D-methionine, Placebo
Medical subject headings: Hearing Loss, Noise-Induced

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

D-methionineDrug
D-methionine, oral liquid suspension
PlaceboDrug
Placebo contains sorbitol, orange flavor and purified water; is flavor and color matched to D-Met.

Study groups in NCT02903355
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo contains sorbitol, orange flavor and purified water; is flavor and color matched to D-Met. Receives: Drug: Placebo
D-methionine, oral liquid suspension	Experimental	D-methionine liquid suspension also contains sorbitol, orange flavor and purified water Intervention: Drug: D-methionine, oral liquid suspension. Receives: Drug: D-methionine

What is being measured

The primary outcome is the main question the study is designed to answer.

ASHA Shift Ear (Left)
An increase of at least 20 dB at any one frequency,
An increase of at least 10 dB at any two consecutive frequencies, or
Loss of response at 3 consecutive frequencies where responses were obtained at baseline.
Measured: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
ASHA Shift Ear (Right)
An increase of at least 20 dB at any one frequency,
An increase of at least 10 dB at any two consecutive frequencies, or
Loss of response at 3 consecutive frequencies where responses were obtained at baseline.
Measured: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
ASHA Shift Ear (Either)
An increase of at least 20 dB at any one frequency,
An increase of at least 10 dB at any two consecutive frequencies, or
Loss of response at 3 consecutive frequencies where responses were obtained at baseline.
Measured: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
ASHA Shift Ear (Both)
An increase of at least 20 dB at any one frequency,
An increase of at least 10 dB at any two consecutive frequencies, or
Loss of response at 3 consecutive frequencies where responses were obtained at baseline.
Measured: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
ASHA Shift Ear (Trigger Hand)
An increase of at least 20 dB at any one frequency,
An increase of at least 10 dB at any two consecutive frequencies, or
Loss of response at 3 consecutive frequencies where responses were obtained at baseline.
Measured: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
ASHA Shift Ear (Non-Trigger Hand)
An increase of at least 20 dB at any one frequency,
An increase of at least 10 dB at any two consecutive frequencies, or
Loss of response at 3 consecutive frequencies where responses were obtained at baseline.
Measured: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).

Secondary outcomes (4)

DOEHRSHC Shift
Greater than or equal to 10 dB change for the average of 2k, 3k, and 4k in either ear. This is a binary outcome measure based on meeting this definition.
Measured: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
EWS STS Shift
Greater than or equal to 15 dB change (deficit) in any of the following frequencies in either ear (1k or 2k or 3k or 4k). This is a binary outcome measure based on meeting this definition.
Measured: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
Total THI Score Change
Tinnitus Handicap Inventory. Tinnitus handicap inventory designed to evaluate the difficulties experienced as a result of hearing loss. Score ranges from 0 to 100 with 0 indicating no handicap, and 100 indicating catastrophic handicap. The THI score was to compare pre and post treatment effects of hearing loss.
Measured: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
Significant Change in Tinnitus
An increase of at least 5 points in the Tinnitus Handicap Inventory (THI), AND an increase in one severity grade category (Categories listed below). Tinnitus handicap inventory is designed to evaluate the difficulties experienced as a result of hearing loss. Score ranges from 0 to 100, with 0 indicating no handicap, and 100 indicating catastrophic handicap. The THI score was to compare pre and post treatment effects of hearing loss.
0-16: Slight or no handicap (Grade 1) 18-36: Mild handicap (Grade 2) 38-56: Moderate handicap (Grade 3) 58-76: Severe handicap (Grade 4) 78-100: Catastrophic handicap (Grade 5)
Measured: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Dec 2017

First posted16 Sep 2016 (estimated)
Study startSep 2013
Primary completionDec 2017
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Noise-induced Hearing LossStudies 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: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 351 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02903355
Sponsor's protocol ID: 01345474
Status last verified: Jun 2022
First submitted: 12 Sep 2016
Last updated: 28 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Noise-induced Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3 Clinical Trial: D-methionine to Reduce Noise-Induced Hearing Loss (NIHL)
ClinicalTrials.gov ID: NCT02903355
Acronym / sponsor ID: 01345474
Conditions: Noise-induced Hearing Loss
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 351 participants (actual)
Lead sponsor: Southern Illinois UniversityUniversity, hospital or other
Study start: Sep 2013
Primary completion: Dec 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 16 Sep 2016 (estimated)
Results: Posted 28 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objective Hypotheses:

Primary Hypothesis: Administration of oral D-methionine prior to, during and 4 days post-weapons training will reduce or prevent permanent noise-induced hearing loss.

Secondary Hypothesis: Administration of oral D-methionine prior to, during and 4 days post-weapons training will reduce or prevent noise-induced tinnitus.

Specific Aims:

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo contains sorbitol, orange flavor and purified water; is flavor and color matched to D-Met.
D-methionine, oral liquid suspension	Experimental	Drug: D-methionineD-methionine liquid suspension also contains sorbitol, orange flavor and purified water Intervention: Drug: D-methionine, oral liquid suspension.

Who may qualify

Ages: 21 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Male or female 21 to 45 years of age Negative pregnancy test at enrollment and prior to taking study drug Willing to use an effective method of birth control during the study (Both male and female participants should avoid pregnancy during study) Pure tone air conduction threshold average at 0.5, 1 and 2 kHz of no greater than 40 dB HL bilaterally with no air bone gaps greater than 10 dB and normal otoscopy and tympanometry screens Willing to refrain from using supplements containing or derived from protein while participating in this study Ability to comply with all study requirements

Key exclusion criteria (1 listed)

History of allergic or idiosyncratic reaction to methionine, amino acid mixtures, nutritional supplements, egg white, or other proteins or food additives Vegetarian (Individual excludes meat and fish from their diet) History of chronic balance disorders Abnormal otoscopic findings, otologic surgery, autoimmune inner ear disease, significant air-bone gaps, abnormal tympanograms or other indication of middle-ear abnormality, history of fluctuant hearing or asymmetric hearing worse than 25 dB at any frequency in either ear, perilymphatic fistula, tumor of the auditory system, or other CNS disorder that is likely to affect hearing Treatment with intravenous (IV) antibiotics within the past 6 months Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug Treatment for alcohol or substance abuse within past 6 months Women of childbearing age who are not using effective contraceptive methods and who may become pregnant during the course of the study Women who are pregnant or breastfeeding. National Guardsmen History of psychotic schizophrenia Exposure within the previous 6 months to systemic ototoxic substances including aminoglycosides or vancomycin Body weight exceeding 225 pounds Renal impairment measured as eGFR < 50 on screening creatinine clearance blood draw.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
D-methionineD-methionine, oral liquid suspension	Drug	D-methionine, oral liquid suspension
PlaceboPlacebo contains sorbitol, orange flavor and purified water; is flavor and color matched to D-Met.	Drug	Placebo

Primary outcome

ASHA Shift Ear (Left)
Time frame: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
An increase of at least 20 dB at any one frequency, An increase of at least 10 dB at any two consecutive frequencies, or Loss of response at 3 consecutive frequencies where responses were obtained at baseline.
ASHA Shift Ear (Right)
Time frame: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
An increase of at least 20 dB at any one frequency, An increase of at least 10 dB at any two consecutive frequencies, or Loss of response at 3 consecutive frequencies where responses were obtained at baseline.
ASHA Shift Ear (Either)
Time frame: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
An increase of at least 20 dB at any one frequency, An increase of at least 10 dB at any two consecutive frequencies, or Loss of response at 3 consecutive frequencies where responses were obtained at baseline.
ASHA Shift Ear (Both)
Time frame: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
An increase of at least 20 dB at any one frequency, An increase of at least 10 dB at any two consecutive frequencies, or Loss of response at 3 consecutive frequencies where responses were obtained at baseline.
ASHA Shift Ear (Trigger Hand)
Time frame: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
An increase of at least 20 dB at any one frequency, An increase of at least 10 dB at any two consecutive frequencies, or Loss of response at 3 consecutive frequencies where responses were obtained at baseline.
ASHA Shift Ear (Non-Trigger Hand)
Time frame: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
An increase of at least 20 dB at any one frequency, An increase of at least 10 dB at any two consecutive frequencies, or Loss of response at 3 consecutive frequencies where responses were obtained at baseline.

4 secondary outcomes

DOEHRSHC Shift
Time frame: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
EWS STS Shift
Time frame: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
Total THI Score Change
Time frame: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).
Significant Change in Tinnitus
Time frame: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).

Results and safety

Results posted to the registry on 28 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	186	142
D-methionine, Oral Liquid Suspension	165	124

Primary outcome: ASHA Shift Ear (Left)

Time frame: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).. Count of participants. Unit: Participants

Measure	Placebo n = 137	D-methionine, Oral Liquid Suspension n = 121
Value	12	9

Placebo vs D-methionine, Oral Liquid Suspension: p = .4385, Fisher Exact

Population analysed: 5 and 3 participants in the placebo and D-methionine arms, respectively, failed a final tympanogram screen in the left ear to rule out middle ear pathology as a cause of the hearing loss and were excluded from the analysis for this outcome.

Primary outcome: ASHA Shift Ear (Right)

Time frame: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).. Count of participants. Unit: Participants

Measure	Placebo n = 139	D-methionine, Oral Liquid Suspension n = 120
Value	12	10

Placebo vs D-methionine, Oral Liquid Suspension: p = .5562, Fisher Exact

Population analysed: 3 and 4 participants in the placebo and D-methionine arms, respectively, failed a final tympanogram screen in the right ear to rule out middle ear pathology as a cause of the hearing loss and were excluded from the analysis for this outcome.

Primary outcome: ASHA Shift Ear (Either)

Time frame: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).. Count of participants. Unit: Participants

Measure	Placebo n = 135	D-methionine, Oral Liquid Suspension n = 117
Value	21	18

Placebo vs D-methionine, Oral Liquid Suspension: p = .5441, Fisher Exact

Population analysed: 7 and 7 participants in the placebo and D-methionine arms, respectively, failed a final tympanogram screen in either ear to rule out middle ear pathology as a cause of the hearing loss and were excluded from the analysis for this outcome.

Primary outcome: ASHA Shift Ear (Both)

Time frame: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).. Count of participants. Unit: Participants

Measure	Placebo n = 135	D-methionine, Oral Liquid Suspension n = 117
Value	3	1

Placebo vs D-methionine, Oral Liquid Suspension: p = .3666, Fisher Exact

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events monitored from first dose to day 36.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 159 (0%)	93 of 159 (58.5%)	0 of 159
D-methionine, Oral Liquid Suspension	0 of 157 (0%)	120 of 157 (76.4%)	0 of 157

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Noise-induced Hearing Loss

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OCCUPATIONAL NOISE AND CHEMICAL EXPOSURE EFFECTS ON AUDITORY AND VESTIBULAR FUNCTION
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Intervention for Hearing Health Among Native Americans
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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.

Kathleen Campbell, PhD principal investigator

MetArmor, Inc.

CPT William Grimes, MD study director

United States Department of Defense, US Army Ft. Jackson, South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing D-methionine in people with Noise-induced Hearing Loss, run by Southern Illinois University at 1 site in United States.

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 1 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: stopped early, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

ASHA Shift Ear (Left) (time frame: Change from baseline to day 29-36 after initial administration of study drug (Day 15-22 after cessation of weapons training).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02903355.

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 28 Jun 2022.