| 1 |
NCT02603081 |
Completed |
Study to Evaluate SPI-1005 in Adults With Meniere's Disease |
|
|
Interventional
|
Phase 1
Phase 2 |
- Sound Pharmaceuticals, Incorporated
- Sound Pharmaceuticals, Incorporated
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures.
- Plasma Ebselen levels of SPI-1005 before, during, and after 21 days of dosing
- Plasma Selenium levels before, during, and after 21 days of dosing
- (and 5 more...)
|
40 |
All |
19 Years to 70 Years (Adult, Older Adult) |
NCT02603081 |
SPI-1005-151 |
|
December 2015 |
August 2017 |
August 2017 |
November 11, 2015 |
October 2, 2017 |
|
- House Clinic
Los Angeles, California, United States - New York Otology
New York, New York, United States - MUSC
Charleston, South Carolina, United States - (and 2 more...)
|
|
| 2 |
NCT02779192 |
Not yet recruiting |
A Phase 2b Study of SPI-1005 to Reduce the Incidence, Severity, and Duration of Acute Noise Induced Hearing Loss |
- Noise Induced Hearing Loss
|
- Drug: SPI-1005 200mg
- Drug: SPI-1005 400mg
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Sound Pharmaceuticals, Incorporated
- Sound Pharmaceuticals, Incorporated
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Reduction in the Incidence of a Significant Threshold Shift
- Improvement in word recognition score
|
180 |
All |
18 Years to 50 Years (Adult) |
NCT02779192 |
SPI-1005-203 |
NIHL |
February 2018 |
August 2019 |
September 2019 |
May 20, 2016 |
January 29, 2018 |
|
- University of Miami
Miami, Florida, United States - University of Kansas Medical Center
Kansas City, Kansas, United States - New York Otology
New York, New York, United States - (and 3 more...)
|
|
| 3 |
NCT03325790 |
Enrolling by invitation |
SPI-1005 for the Treatment of Patients With Meniere's Disease |
|
- Drug: 200mg SPI-1005 BID
- Drug: 400mg SPI-1005 BID
- Other: Placebo
|
Interventional
|
Phase 2 |
- Sound Pharmaceuticals, Incorporated
- Sound Pharmaceuticals, Incorporated
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Safety of SPI-1005 treatment in adults with Meniere's disease: Number and severity of adverse events
- Efficacy of SPI-1005 on hearing loss: Improvement in sensorineural hearing loss from baseline using pure tone audiometry
- Efficacy of SPI-1005 on word recognition: Improvement in word recognition score
- (and 4 more...)
|
120 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT03325790 |
SPI-1005-251 |
|
September 28, 2017 |
September 2018 |
November 2018 |
October 30, 2017 |
November 9, 2017 |
|
- House Clinic
Los Angeles, California, United States - New York Otology
New York, New York, United States - MUSC
Charleston, South Carolina, United States - Northwest Ear, Inc.
Seattle, Washington, United States
|
|
| 4 |
NCT02819856 |
Enrolling by invitation |
SPI-1005 for Prevention and Treatment of Aminoglycoside Induced Ototoxicity |
|
- Drug: Placebo
- Drug: SPI-1005 Ebselen 200mg Capsule x1
- Drug: SPI-1005 Ebselen 200mg Capsule x2
- Drug: SPI-1005 Ebselen 200mg Capsule x3
|
Interventional
|
Phase 1
Phase 2 |
- Sound Pharmaceuticals, Incorporated
- Medical University of South Carolina
- Cystic Fibrosis Foundation Therapeutics
- Sound Pharmaceuticals, Incorporated
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- Severity of sensorineural hearing loss
- Speech discrimination
- (and 4 more...)
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT02819856 |
SPI-3005-501 |
|
September 21, 2017 |
August 2018 |
December 2018 |
June 30, 2016 |
January 29, 2018 |
|
- Medical University of South Carolina
Charleston, South Carolina, United States
|
|
| 5 |
NCT01451853 |
Not yet recruiting |
SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss |
- Lung Cancer
- Head and Neck Cancer
- Hearing Loss
- (and 3 more...)
|
- Drug: SPI-1005 Low Dose
- Drug: SPI-1005 Middle Dose
- Drug: SPI-1005 High Dose
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Sound Pharmaceuticals, Incorporated
- VA Puget Sound Health Care System
- Sound Pharmaceuticals, Incorporated
|
Industry / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of participants with adverse events
- Reduction of hearing loss incidence and severity
- Reduction of tinnitus incidence and severity.
|
80 |
All |
19 Years to 80 Years (Adult, Older Adult) |
NCT01451853 |
SPI-3005-201 |
|
January 15, 2018 |
June 26, 2019 |
September 23, 2019 |
October 14, 2011 |
September 25, 2017 |
|
- VA Puget Sound Health Care
Seattle, Washington, United States
|
|
| 6 |
NCT01444846 |
Completed |
Otoprotection With SPI-1005 for Prevention of Temporary Auditory Threshold Shift |
- Temporary Auditory Threshold Shift
|
- Drug: SPI-1005 Low dose
- Drug: SPI-1005 Middle dose
- Drug: SPI-1005 High dose
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Sound Pharmaceuticals, Incorporated
- University of Florida
- Sound Pharmaceuticals, Incorporated
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Reduction in Temporary Threshold Shift
|
83 |
All |
18 Years to 31 Years (Adult) |
NCT01444846 |
SPI-1005-202 |
|
September 2011 |
December 2013 |
March 2014 |
October 3, 2011 |
August 28, 2014 |
|
- University of Florida
Gainsville, Florida, United States
|
|
| 7 |
NCT01452607 |
Completed |
Study to Evaluate the Safety and Pharmacokinetics of SPI-1005 |
|
- Drug: SPI-1005
- Drug: Placebo
|
Interventional
|
Phase 1 |
- Sound Pharmaceuticals, Incorporated
- Sound Pharmaceuticals, Incorporated
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- Pharmacokinetics of SPI-1005 and its major metabolites in healthy subjects
|
32 |
All |
19 Years to 50 Years (Adult) |
NCT01452607 |
SPI-1005-101 |
|
May 2006 |
August 2006 |
August 2006 |
October 17, 2011 |
June 29, 2016 |
|
- MDS Pharma Services
Lincoln, Nebraska, United States
|
|
| 8 |
NCT03013400 |
Recruiting |
Ebselen as an add-on Treatment in Hypo/Mania |
- Bipolar Disorder
- Bipolar Disorder, Manic
|
- Drug: Ebselen
- Drug: Placebo oral capsule
|
Interventional
|
Phase 2 |
- University of Oxford
- Stanley Medical Research Institute
- Sound Pharmaceuticals, Incorporated
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Young Mania Rating Scale (YMRS)
- Change in Clinical Global Impressions Bipolar (CGI-BP) mania scale
- Change in Altman Self Rating Mania Scale (ASRM)
- (and 9 more...)
|
60 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT03013400 |
172518
2015-000323-86 |
|
October 1, 2017 |
June 2020 |
June 2020 |
January 6, 2017 |
November 6, 2017 |
|
- Neurosciences Building, Dept. Psychiatry, Warneford Hospital
Oxford, Oxfordshire, United Kingdom
|
|
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