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NCT02603081 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate SPI-1005 in Adults With Meniere's Disease

A Phase 1 study, sponsored by Sound Pharmaceuticals, Incorporated.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target

NCT02603081: Completed Phase 1 study, sponsored by Sound Pharmaceuticals, Incorporated.

NCT02603081 is a Phase 1 study that has completed, run by Sound Pharmaceuticals, Incorporated. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02603081, a Phase 1 study, has completed, sponsored by Sound Pharmaceuticals, Incorporated.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target

Study Summary

This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere's disease.

Primary Outcome

Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures.

Interventions

  • DRUG SPI-1005

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2015-12
Est. Completion 2017-08
Phase Phase 1

What the finished NCT02603081 record still lists

NCT02603081 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).

The record links to 0 conditions, and to 1 intervention - of which SPI-1005 is the first listed.

NCT02603081 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02603081 about?

NCT02603081 is a clinical study titled "Study to Evaluate SPI-1005 in Adults With Meniere's Disease". This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere's disease.

What is the current status of trial NCT02603081?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2015-12. Estimated completion is 2017-08.

What interventions are being tested in trial NCT02603081?

The interventions under investigation include: SPI-1005 (DRUG).

Who is sponsoring clinical trial NCT02603081?

This trial is sponsored by Sound Pharmaceuticals, Incorporated, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02603081's enrollment target sits among peer trials

40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02603081, the US trial registry maintained by the National Library of Medicine. NCT02603081 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.