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| ID | Type | Description | Link |
|---|---|---|---|
| Meniere's Disease | Other Identifier | House Research Institute |
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HRI no longer conducting research.
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| Name | Class |
|---|---|
| House Clinic, Inc. | INDUSTRY |
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The specific aim of this study is to determine the efficacy of treatment with famciclovir in unilateral Meniere's Disease patients, specifically whether hearing can be improved. The investigators will determine the percentage of unilateral Meniere's Disease patients experiencing an absence of hearing fluctuation after 3 months of treatment with famciclovir as compared to the placebo arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Arm | Placebo Comparator | Treatment with 3 months of placebo |
|
| Active Arm | Active Comparator | Treatment with 3 months of active drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famciclovir | Drug | Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months on drug). |
| Measure | Description | Time Frame |
|---|---|---|
| Pure-tone Threshold Change | Change in hearing from baseline to after 3 months of treatment | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tinnitus and/or Dizziness Handicap Change | Change in tinnitus and/or dizziness from baseline to after 3 months of treatment | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Derebery, MD | House Research Institute | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Arm | Treatment with 3 months of placebo Placebo: Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months). |
| FG001 | Active Arm | Treatment with 3 months of active drug Famciclovir: Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months on drug). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
early termination of study and sponsor organization closed
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Arm | Treatment with 3 months of placebo Placebo: Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| 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 | Pure-tone Threshold Change | Change in hearing from baseline to after 3 months of treatment | early termination of study and sponsor organization closed | Posted | 3 months |
|
early termination of study and sponsor organization closed
early termination of study and sponsor organization closed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Arm | Treatment with 3 months of placebo Placebo: Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mahta Marefat | House Institute Foundation | (213) 770-1808 | mmarefat@hifla.org |
| ID | Term |
|---|---|
| D008575 | Meniere Disease |
| D014717 | Vertigo |
| D034381 | Hearing Loss |
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D018159 | Endolymphatic Hydrops |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000077595 | Famciclovir |
| ID | Term |
|---|---|
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Placebo | Drug | Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months). |
|
| Active Arm |
Treatment with 3 months of active drug Famciclovir: Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months on drug). |
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
| Region of Enrollment | participants |
|
|
| Secondary | Tinnitus and/or Dizziness Handicap Change | Change in tinnitus and/or dizziness from baseline to after 3 months of treatment | early termination of study and sponsor organization closed | Posted | 3 months |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Active Arm | Treatment with 3 months of active drug Famciclovir: Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months on drug). | 0 | 0 | 0 | 0 | 0 | 0 |
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| D015837 |
| Vestibular Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006311 | Hearing Disorders |
| D012678 | Sensation Disorders |
| D006571 |
| Heterocyclic Compounds |