A Phase 2 interventional study of 200mg SPI-1005 BID and 400mg SPI-1005 BID in Meniere's Disease, sponsored by Sound Pharmaceuticals, Incorporated. Completed at 13 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-18.
Sponsored by Sound Pharmaceuticals, Incorporated · Phase 2, Interventional, and Treatment
This study will evaluate the safety, efficacy, and Pharmacokinetics (PK) of two dose levels of SPI-1005 administered for 28 days compared to placebo in patients with Meniere's disease.
Study participants will be randomized to SPI-1005 or placebo in this double-blind study to evaluate both safety and efficacy of the investigational treatment. Participants, aged 18-75 years, with probable or definite Meniere's disease will undergo baseline testing to assess severity of sensorineural hearing loss, tinnitus and vertigo. During the study, and 28 days after completion of treatment, participants will be evaluated for safety (adverse events, physical examinations, vital signs and clinical laboratory testing (CBC,serum chemistry). Trough plasma levels of ebselen and its major metabolite will be determined using liquid chromatography-mass spectrometry (LCMS) at specified visits. Additionally, plasma will be analyzed for selenium at the corresponding visits. The effect of SPI-1005 on hearing and balance will be evaluated. Tinnitus (TFI) and vertigo (VSS) will be evaluated at baseline, during and study treatment.
74 studies on the registry are indexed under Meniere Disease; 12 are open to participants now.
This study's enrollment of 149 is above the median of 44 across 61 interventional studies indexed under Meniere Disease.
Browse Meniere Disease studies →Sound Pharmaceuticals, Incorporated is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Females of should either be sexually inactive (abstinent) for 14 days prior to screening and throughout the study or be using one of the following acceptable methods:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo
Other: Placebo
200mg SPI-1005 BID
Drug: 200mg SPI-1005 BID
400mg SPI-1005 BID
Drug: 400mg SPI-1005 BID
Active: low dose
Also known as: ebselen
Active: high dose
Also known as: ebselen
Placebo Comparator
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Number and severity of adverse events in patients treated with placebo versus SPI-1005. Outcome Measure 1 includes all adverse events, including those which are not reported in the Adverse Event module, i.e., adverse events which did not result in death, were not Serious Adverse Events, and which were below the frequency threshold (5%) in any arm as required for reporting.
Time frame: 8 weeks
Efficacy of SPI-1005 on Hearing Loss
Improvement in sensorineural hearing loss from baseline using Pure Tone Audiometry
Time frame: 8 weeks
Efficacy of SPI-1005 on Word Recognition Score
Improvement in Words-in-Noise (WIN) test score from baseline. WIN test score, 0-35 words, in which a higher score means a better outcome.
Time frame: 8 weeks
Efficacy of SPI-1005 on Tinnitus
Improvement in the Tinnitus Functional Index (TFI) from baseline. TFI Total Score: 0-100, in which a higher score means a worse outcome.
Time frame: 8 weeks
Efficacy of SPI-1005 on Tinnitus Loudness
Improvement in Tinnitus Loudness (TL) on response to Tinnitus Functional Index Question Number 2. Question Number 2: "How Strong or Loud is your tinnitus?": 0-10, in which a higher score means a worse outcome.
Time frame: 8 weeks
Efficacy of SPI-1005 on Vertigo
Improvement in Vertigo Symptom Scale (VSS) from baseline. VSS Total Scale: 0-60, in which a higher score means a worse outcome
Time frame: 8 weeks
Trough Plasma Concentration of SPI-1005
Trough plasma concentration of SPI-1005 (ebselen) will be determined at certain time intervals
Time frame: 2 weeks, 4 weeks, 8 weeks
| Milestone | Placebo | 200mg SPI-1005 Twice Daily (BID) | 400mg SPI-1005 BID |
|---|---|---|---|
| Started | 42 | 42 | 42 |
| Completed | 41 | 41 | 38 |
| Not completed | 1 | 1 | 4 |
Number and severity of adverse events in patients treated with placebo versus SPI-1005. Outcome Measure 1 includes all adverse events, including those which are not reported in the Adverse Event module, i.e., adverse events which did not result in death, were not Serious Adverse Events, and which were below the frequency threshold (5%) in any arm as required for reporting.
| Participants | Placebo | 200mg SPI-1005 Twice Daily (BID) | 400mg SPI-1005 BID |
|---|---|---|---|
| Total Number of Patients with Treatment Emergent Adverse Events (TEAE) | 19 | 20 | 20 |
| Number of Patients with Mild TEAE | 15 | 18 | 18 |
| Number of Patients with Moderate TEAE | 6 | 3 | 7 |
| Number of Patients with Severe TEAE | 0 | 0 | 2 |
Improvement in sensorineural hearing loss from baseline using Pure Tone Audiometry
| Participants | Placebo | 200mg SPI-1005 Twice Daily (BID) | 400mg SPI-1005 BID |
|---|---|---|---|
| Threshold Improvement from Baseline >=10 dB in at least 1 low frequency (250, 500, or 1000 Hz) — Yes | 15 | 16 | 25 |
| Threshold Improvement from Baseline >=10 dB in at least 1 low frequency (250, 500, or 1000 Hz) — No | 26 | 26 | 16 |
| Threshold Improvement >=10 dB in 2 adjacent low frequencies (250 and 500 Hz, or 500 and 1000 Hz) — Yes | 8 | 7 | 15 |
| Threshold Improvement >=10 dB in 2 adjacent low frequencies (250 and 500 Hz, or 500 and 1000 Hz) — No | 33 | 35 | 25 |
Improvement in Words-in-Noise (WIN) test score from baseline. WIN test score, 0-35 words, in which a higher score means a better outcome.
| Participants | Placebo | 200mg SPI-1005 Twice Daily (BID) | 400mg SPI-1005 BID |
|---|---|---|---|
| WIN Score Improvement from Baseline >=10% — Yes | 23 | 23 | 30 |
| WIN Score Improvement from Baseline >=10% — No | 18 | 18 | 10 |
| WIN Score Improvement from Baseline >=20% — Yes | 19 | 17 | 27 |
| WIN Score Improvement from Baseline >=20% — No | 22 | 24 | 13 |
| WIN Score Improvement from Baseline >= 4 words — Yes | 14 | 13 | 24 |
| WIN Score Improvement from Baseline >= 4 words — No | 27 | 28 | 16 |
Improvement in the Tinnitus Functional Index (TFI) from baseline. TFI Total Score: 0-100, in which a higher score means a worse outcome.
| Participants | Placebo | 200mg SPI-1005 Twice Daily (BID) | 400mg SPI-1005 BID |
|---|---|---|---|
| TFI Total Score >= 10pt. reduction from Baseline | 20 | 19 | 13 |
| No TFI Total Score >= 10pt. reduction from Baseline | 21 | 23 | 28 |
Improvement in Tinnitus Loudness (TL) on response to Tinnitus Functional Index Question Number 2. Question Number 2: "How Strong or Loud is your tinnitus?": 0-10, in which a higher score means a worse outcome.
| Participants | Placebo | 200mg SPI-1005 Twice Daily (BID) | 400mg SPI-1005 BID |
|---|---|---|---|
| TL >= 2pt. reduction from Baseline | 14 | 15 | 14 |
| No TL >= 2pt. reduction from Baseline | 27 | 27 | 27 |
Improvement in Vertigo Symptom Scale (VSS) from baseline. VSS Total Scale: 0-60, in which a higher score means a worse outcome
| Participants | Placebo | 200mg SPI-1005 Twice Daily (BID) | 400mg SPI-1005 BID |
|---|---|---|---|
| VSS Total Scale >= 6pt. reduction from Baseline | 21 | 21 | 18 |
| No VSS Total Scale >= 6pt. reduction from Baseline | 20 | 21 | 23 |
Trough plasma concentration of SPI-1005 (ebselen) will be determined at certain time intervals
| ng/mL | 200mg SPI-1005 Twice Daily (BID) | 400mg SPI-1005 BID |
|---|---|---|
| 2 weeks | 27.2 ± 19.8 | 48.4 ± 33.2 |
| 4 weeks | 19.7 ± 14.7 | 40.6 ± 29.1 |
| 8 weeks | 0 ± 0 | 0 ± 0 |
Collected over 8 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/42 (0%) | 0/42 (0%) | 3/42 (7.1%) |
| 200mg SPI-1005 Twice Daily (BID) | 0/42 (0%) | 0/42 (0%) | 7/42 (16.7%) |
| 400mg SPI-1005 BID | 0/42 (0%) | 0/42 (0%) | 8/42 (19%) |
| Event | Placebo | 200mg SPI-1005 Twice Daily (BID) | 400mg SPI-1005 BID |
|---|---|---|---|
| Blood triglycerides increasedInvestigations | 1/42 | 5/42 | 1/42 |
| Upper respiratory tract infectionInfections and infestations | 1/42 | 2/42 | 4/42 |
| Alanine aminotransferase increasedInvestigations | 0/42 | 3/42 | 4/42 |
| Gamma-glutamyltransferase increasedInvestigations | 1/42 | 3/42 | 0/42 |
| Age, Continuous(years) | Placebo | 200mg SPI-1005 Twice Daily (BID) | 400mg SPI-1005 BID | Total |
|---|---|---|---|---|
| Mean | 55.1 ± 13.03 | 55.9 ± 9.55 | 50.6 ± 10.55 | 53.9 ± 11.30 |
| Sex: Female, Male(Participants) | Placebo | 200mg SPI-1005 Twice Daily (BID) | 400mg SPI-1005 BID | Total |
|---|---|---|---|---|
| Female | 20 | 26 | 20 | 66 |
| Male | 22 | 16 | 22 | 60 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | 200mg SPI-1005 Twice Daily (BID) | 400mg SPI-1005 BID | Total |
|---|---|---|---|---|
| Hispanic or Latino | 3 | 7 | 4 | 14 |
| Not Hispanic or Latino | 39 | 35 | 38 | 112 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | 200mg SPI-1005 Twice Daily (BID) | 400mg SPI-1005 BID | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 1 |
| Asian | 2 | 0 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 2 | 5 |
| White | 39 | 37 | 39 | 115 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 1 | 3 |
| Region of Enrollment(participants) | Placebo | 200mg SPI-1005 Twice Daily (BID) | 400mg SPI-1005 BID | Total |
|---|---|---|---|---|
| United States | 42 | 42 | 42 | 126 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Ebselen
Sound Pharmaceuticals, Incorporated