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Organoselenium Compound

SPI-1005 Ebselen 200mg Capsule x2 for Ototoxicity

Phase 2
Waitlist Available
Research Sponsored by Sound Pharmaceuticals, Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 weeks
Awards & highlights

Study Summary

This trialis testing a drug to treat cystic fibrosis patients experiencing a lung flare-up and will measure its safety, effectiveness and other factors.

Eligible Conditions
  • Ototoxicity
  • Hearing Loss

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in lung function
Distortion Product Otoacoustic Emissions
Sensorineural Hearing Loss (disorder)
+4 more
Secondary outcome measures
Pharmacodynamics of Glutathione, cysteine and cystine
Pharmacodynamics of Nrf2
Pharmacogenomics

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: SPI-1005 Ebselen 200mg Capsule x3Experimental Treatment1 Intervention
600mg SPI-1005 bid po x 21d High Dose Arm
Group II: SPI-1005 Ebselen 200mg Capsule x2Experimental Treatment1 Intervention
400mg SPI-1005 bid po x 21d Mid Dose Arm
Group III: SPI-1005 Ebselen 200mg Capsule x1Experimental Treatment1 Intervention
200mg SPI-1005 bid po x 21d Low Dose Arm
Group IV: SPI-1000 Capsule 0mg Ebselen PlaceboPlacebo Group1 Intervention
0mg Ebselen SPI-1000 bid po x 21d

Find a Location

Who is running the clinical trial?

Sound Pharmaceuticals, IncorporatedLead Sponsor
12 Previous Clinical Trials
1,088 Total Patients Enrolled
1 Trials studying Ototoxicity
80 Patients Enrolled for Ototoxicity
Medical University of South CarolinaOTHER
936 Previous Clinical Trials
7,396,758 Total Patients Enrolled
1 Trials studying Ototoxicity
105 Patients Enrolled for Ototoxicity
Cystic Fibrosis FoundationOTHER
189 Previous Clinical Trials
37,130 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA endorsed SPI-1005 Ebselen 200mg Capsule x2?

"SPI-1005 Ebselen 200mg Capsule x2 has been rated a 2 on the safety scale by Power, as this is still only in Phase 2 and there are no findings to support its efficacy yet."

Answered by AI

Could you please provide an overview of the past research surrounding SPI-1005 Ebselen 200mg Capsule x2?

"Presently, 5 clinical trials are being conducted in order to assess the efficacy of SPI-1005 Ebselen 200mg Capsule x2. 1 is currently in Phase 3. Despite there being a primary base for these studies located in Winston-Salem, North carolina, 41 different medical centres are hosting related investigations."

Answered by AI

How many individuals are involved in the research project?

"Sadly, this research study has already closed its enrollment process. It was initially posted in July 2017 and last updated in December 2022. If one is searching for alternative trials, there are presently 140 studies recruiting patients with cystic fibrosis and 5 clinical trials actively enrolling participants to test SPI-1005 Ebselen 200mg Capsule x2."

Answered by AI

Is this pioneering research a unique endeavor?

"Research on SPI-1005 Ebselen 200mg Capsule x2 began in 2017, when its first clinical trial was funded by Sound Pharmaceuticals Inc. Subsequent to this investigation of 80 participants, the drug obtained phase 2 approval and is now subject to 5 active studies across two nations with a total of 24 centres involved."

Answered by AI

Is it feasible to sign up for participation in this research study at present?

"This research endeavour has ended its search for participants. It was initially posted on the 21st of July 2017 before being updated lastly on December 7th 2022. If you are still interested in finding clinical trials, 140 studies for cystic fibrosis and 5 concerning SPI-1005 Ebselen 200mg Capsule x2 are currently recruiting patients."

Answered by AI
~10 spots leftby May 2025