Not provided
Not provided
Not provided
Not provided
PINIHL Program terminated by DoD
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Texas | OTHER |
| Gateway Biotechnology, Inc. | INDUSTRY |
| United States Department of Defense | FED |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety and efficacy of zonisamide for the treatment of noise-induced hearing loss in adults.
This study is a randomized, double-blinded placebo-control trial with three parallel groups, to make use of a common control group. After being informed about the study expectations and potential risks, all individuals providing written informed consent will undergo screening to determine eligibility for study entry.
Participants who meet the eligibility requirements will be randomized in a balanced fashion into one of 3 arms:
Group 1) Zonisamide 100 milligrams (mg) pre-op + Placebo post-op; Group 2) Placebo pre- + placebo post-op; and Group 3) Zonisamide 100 mg post-op + placebo post-op
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zonisamide Pre-op + Placebo Post-op | Active Comparator | For subjects randomized to zonisamide pre-op, the pre-op package will contain one zonisamide capsule (100 mg PO) and the post-op package will contain one placebo capsule that looks, smells, and tastes the same as zonisamide capsules. |
|
| Placebo Pre-op + Placebo Post-op | Placebo Comparator | For the subjects randomized to placebo, both pre- and post-op packages will contain placebo capsules that looks, smells, and taste the same as zonisamide capsules. |
|
| Placebo Pre-op + Zonisamide Post-op | Active Comparator | For subjects randomized to zonisamide post-op, the pre-op package will contain one placebo capsule and the post-op package will contain one zonisamide capsule (100 mg PO). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zonisamide 100Mg Cap | Drug | ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Ratio of PTS-positive Subjects | The primary efficacy endpoint will be the proportion of PTS-positive subjects defined as the ratio of PTS-positive subjects to total number of subjects within each study arm/group. Subjects defined as PTS-positive will demonstrate an increase in threshold that is ≥10 dB HL at any frequency from 2-6 kHz post-surgery as compared to baseline audiogram. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| The Rate of Distortion Product Otoacoustic Emissions (DPOAE) Shift | The secondary efficacy outcome measures will be the rate of temporary cochlear change as measured by a DPOAE amplitude shift at any frequency that is significantly greater than the stability of each measurement (i.e., 95% confidence interval of each measurement do not overlap). The rate of DPOAE shift is the ratio of DPOAE shift-positive subjects to total subjects within each arm. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Craig A Buchman, MD, FACS | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
24 participants were consented for the study and enrolled. However, after consent but before any study activities could occur (including randomization), one participant chose to no longer participate. This excluded participant did not complete any study activities after consent. Thus, only 23 participants were consented and completed study activities including randomization.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Zonisamide Pre-op + Placebo Post-op | For subjects randomized to zonisamide pre-op, the pre-op package will contain one zonisamide capsule (100 mg PO) and the post-op package will contain one placebo capsule that looks, smells, and tastes the same as zonisamide capsules. Zonisamide 100Mg Cap: ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide. Placebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule. |
| FG001 | Placebo Pre-op + Placebo Post-op | For the subjects randomized to placebo, both pre- and post-op packages will contain placebo capsules that looks, smells, and taste the same as zonisamide capsules. Placebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule. |
| FG002 | Placebo Pre-op + Zonisamide Post-op | For subjects randomized to zonisamide post-op, the pre-op package will contain one placebo capsule and the post-op package will contain one zonisamide capsule (100 mg PO). Zonisamide 100Mg Cap: ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide. Placebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Zonisamide Pre-op + Placebo Post-op | For subjects randomized to zonisamide pre-op, the pre-op package will contain one zonisamide capsule (100 mg PO) and the post-op package will contain one placebo capsule that looks, smells, and tastes the same as zonisamide capsules. Zonisamide 100Mg Cap: ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide. Placebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Ratio of PTS-positive Subjects | The primary efficacy endpoint will be the proportion of PTS-positive subjects defined as the ratio of PTS-positive subjects to total number of subjects within each study arm/group. Subjects defined as PTS-positive will demonstrate an increase in threshold that is ≥10 dB HL at any frequency from 2-6 kHz post-surgery as compared to baseline audiogram. | ITT Sample Set | Posted | Count of Participants | Participants | 30 days |
|
Adverse Events were assessed from time of oral dose at the surgery visit to the final visit (30 days post-op, +/- 3 days). Total period of time over which adverse event data were collected were 30 days +/- 3 days.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zonisamide Pre-op + Placebo Post-op | For subjects randomized to zonisamide pre-op, the pre-op package will contain one zonisamide capsule (100 mg PO) and the post-op package will contain one placebo capsule that looks, smells, and tastes the same as zonisamide capsules. Zonisamide 100Mg Cap: ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide. Placebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toxicity to Various Agents | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Craig Buchman, Lindburg Professor & Chair, Department of Otolaryngology-Head & Neck Surgery | Washington University in St. Louis | 314-362-2914 | buchmanc@wustl.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 3, 2023 | Dec 4, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 21, 2023 | Aug 27, 2024 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006317 | Hearing Loss, Noise-Induced |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078305 | Zonisamide |
| D002214 | Capsules |
| C109691 | microcrystalline cellulose |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
Not provided
Not provided
This study is a randomized, double-blinded placebo-control trial with three parallel groups, to make use of a common control group.
Not provided
Not provided
Subjects will be randomized in a balanced fashion into one of 3 arms: Zonisamide 100 mg pre-op, Placebo, or Zonisamide 100 mg post-op.
To ensure double-blinding of the trial, each subject will be assigned a previously prepared envelope with one package labeled "1" and designated to be taken 4 hours prior to surgery and another package labeled "2" designated to be taken within 4-12 hours after surgery or when the patient is released clinically to oral medication.
|
| Placebo | Drug | The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule. |
|
|
| 30 days |
| BG001 | Placebo Pre-op + Placebo Post-op | For the subjects randomized to placebo, both pre- and post-op packages will contain placebo capsules that looks, smells, and taste the same as zonisamide capsules. Placebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule. |
| BG002 | Placebo Pre-op + Zonisamide Post-op | For subjects randomized to zonisamide post-op, the pre-op package will contain one placebo capsule and the post-op package will contain one zonisamide capsule (100 mg PO). Zonisamide 100Mg Cap: ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide. Placebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo Pre-op + Placebo Post-op | For the subjects randomized to placebo, both pre- and post-op packages will contain placebo capsules that looks, smells, and taste the same as zonisamide capsules. Placebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule. |
| OG002 | Placebo Pre-op + Zonisamide Post-op | For subjects randomized to zonisamide post-op, the pre-op package will contain one placebo capsule and the post-op package will contain one zonisamide capsule (100 mg PO). Zonisamide 100Mg Cap: ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide. Placebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule. |
|
|
| Secondary | The Rate of Distortion Product Otoacoustic Emissions (DPOAE) Shift | The secondary efficacy outcome measures will be the rate of temporary cochlear change as measured by a DPOAE amplitude shift at any frequency that is significantly greater than the stability of each measurement (i.e., 95% confidence interval of each measurement do not overlap). The rate of DPOAE shift is the ratio of DPOAE shift-positive subjects to total subjects within each arm. | ITT Sample | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 0 |
| 8 |
| 2 |
| 8 |
| 8 |
| 8 |
| EG001 | Placebo Pre-op + Placebo Post-op | For the subjects randomized to placebo, both pre- and post-op packages will contain placebo capsules that looks, smells, and taste the same as zonisamide capsules. Placebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule. | 0 | 7 | 1 | 7 | 7 | 7 |
| EG002 | Placebo Pre-op + Zonisamide Post-op | For subjects randomized to zonisamide post-op, the pre-op package will contain one placebo capsule and the post-op package will contain one zonisamide capsule (100 mg PO). Zonisamide 100Mg Cap: ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide. Placebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule. | 0 | 8 | 1 | 8 | 8 | 8 |
| Brain Oedema | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Cerebrial Infarction | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Facial Paralysis | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Facial paresis | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Long thoracic nerve palsy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Deafness unilateral | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Pseudomeningocele | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Tongue injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Eyelid ptosis | Eye disorders | MedDRA | Systematic Assessment |
|
| SARS-CoV-2 test positive | Investigations | MedDRA | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D010038 |
| Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Sulfur Compounds |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| Excluded |
|