| 1 |
NCT02717442 |
Terminated |
Study of OTO-104 in Subjects With Unilateral Meniere's Disease |
|
- Drug: OTO-104
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Reduction in number of definitive vertigo days compared to placebo as assessed by a daily diary
- Change in hearing from baseline as assessed by audiometry
- Change in the condition of the ear from baseline as assessed by otoscopic examinations
- (and 2 more...)
|
176 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT02717442 |
104-201508 |
AVERTS-2 |
March 2016 |
September 2017 |
September 2017 |
March 23, 2016 |
September 15, 2017 |
|
- Many sites in Europe. Refer to the contact info listed below.
San Diego, California, United States
|
| 2 |
NCT02612337 |
Completed |
Study of OTO-104 in Subjects With Unilateral Meniere's Disease |
|
- Drug: OTO-104
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Reduction in number of definitive vertigo days compared to placebo
- Audiometry
- Otoscopic examinations
- (and 2 more...)
|
165 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT02612337 |
104-201506 |
AVERTS-1 |
October 2015 |
August 2017 |
August 2017 |
November 23, 2015 |
August 21, 2017 |
|
- Many sites in US. Refer to the contact info listed below.
San Diego, California, United States
|
| 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
|
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, Senior) |
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 |
NCT01973114 |
Unknown † |
Latanoprost for the Treatment of Menière's Disease |
|
- Drug: Latanoprost
- Other: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in speech discrimination score in noise from Baseline
- Change in pure tone audiometry from Baseline
- Change in THI-25 (Tinnitus Handicap Inventory) score from Baseline
- (and 4 more...)
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT01973114 |
M 05 - 2013 |
|
October 2013 |
May 2016 |
|
October 31, 2013 |
March 23, 2016 |
|
- Falu Lasarett
Falun, Sweden - Sahlgrenska Universitetssjukhuset
Göteborg, Sweden - Blekinge Hospital
Karlskrona, Sweden - (and 9 more...)
|
| 5 |
NCT01454726 |
Completed
Has Results |
Clinical Trial of Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease |
|
- Other: Diaoshi Jifa therapy plus the Western medical treatment.
- Other: drug
|
Interventional |
Phase 3 |
- Beijing Administration of Traditional Chinese Medicine Bureau
- Beijing Hospital of Traditional Chinese Medicine
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Dizziness Handicap Inventory (DHI) Questionnaire Score
|
27 |
All |
20 Years to 70 Years (Adult, Senior) |
NCT01454726 |
JJT2010-22 |
TCDMD |
January 2011 |
November 2011 |
November 2011 |
October 19, 2011 |
December 24, 2012 |
December 24, 2012 |
- Xuan Wu Hosipital
Beijing, Beijing, China
|
| 6 |
NCT02768662 |
Terminated |
A 6-Month Extension Study of OTO-104 in Meniere's Disease |
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety as assessed by adverse events
- Safety as assessed by otoscopic exams
|
141 |
All |
18 Years and older (Adult, Senior) |
NCT02768662 |
104-201610 |
|
August 2016 |
September 2017 |
September 2017 |
May 11, 2016 |
September 15, 2017 |
|
- Many sites in Europe. Refer to the contact info listed below.
San Diego, California, United States
|
| 7 |
NCT02740387 |
Terminated |
Open Label Study of OTO-104 in Subjects With Meniere's Disease |
|
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Evaluation of adverse events as a measure of safety and tolerability
- Change in hearing from baseline as assessed by audiometry
- Changes in patient condition assessed by otoscopy
- Changes in patient condition assessed by tympanometry
|
34 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02740387 |
104-201505 |
|
June 2016 |
September 2017 |
September 2017 |
April 15, 2016 |
September 15, 2017 |
|
- Call Otonomy call center for trial locations
London, Ontario, Canada
|
| 8 |
NCT02706730 |
Terminated |
A 6-Month Extension Study of OTO-104 in Meniere's Disease |
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety as assessed by adverse events
- Safety as assessed by otoscopic exams
|
189 |
All |
18 Years and older (Adult, Senior) |
NCT02706730 |
104-201509 |
|
February 2016 |
September 2017 |
September 2017 |
March 11, 2016 |
September 15, 2017 |
|
- Many sites in US. Refer to the contact info listed below.
San Diego, California, United States
|
| 9 |
NCT02603081 |
Completed |
Study to Evaluate SPI-1005 in Adults With Meniere's Disease |
|
|
Interventional |
Phase 1
Phase 2 |
- 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, Senior) |
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...)
|
| 10 |
NCT02371798 |
Withdrawn |
Unilateral Meniere Disease: Can Double Dose Gadolinium and Delayed Imaging Make the Diagnosis? |
|
- Drug: Gadopentetate dimeglumine
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Diagnostic
|
- Grade of endolymphatic hydrops (EH) in the cochlea and vestibule
|
0 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT02371798 |
IRB00077659 |
|
February 2015 |
November 2016 |
November 2016 |
February 26, 2015 |
December 1, 2016 |
|
- Emory University Department of Otolaryngology Clinic
Atlanta, Georgia, United States
|
| 11 |
NCT02530931 |
Recruiting |
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease |
|
|
Interventional |
Phase 4 |
- University Hospital, Grenoble
- Guerbet
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted-Imaging dynamic measurement
|
47 |
All |
40 Years and older (Adult, Senior) |
NCT02530931 |
38RC15.173 |
PROSPER |
March 2016 |
December 2018 |
June 2019 |
August 21, 2015 |
March 27, 2018 |
|
- GrenobleUniversityHospital
Grenoble, France
|
| 12 |
NCT00802529 |
Completed
Has Results |
Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease |
|
- Drug: Methylprednisolone
- Drug: Gentamicin
|
Interventional |
Phase 2
Phase 3 |
- Imperial College London
- Imperial College Healthcare NHS Trust
- Medical Research Council
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Vertigo Attacks
- Change in Hearing
- Change in Speech Discrimination
|
60 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT00802529 |
CRO1135 |
|
April 2009 |
May 2015 |
May 2015 |
December 5, 2008 |
October 24, 2016 |
October 24, 2016 |
- Imperial college Healthcare NHS Trust
London, United Kingdom
|
| 13 |
NCT01526408 |
Terminated |
Famvir for Treatment of Hearing in Unilateral Meniere's Disease |
|
- Drug: Famciclovir
- Drug: Placebo
|
Interventional |
Phase 3 |
- House Research Institute
- House Clinic, Inc.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Pure-tone threshold change
- Tinnitus and/or dizziness handicap change
|
11 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT01526408 |
HRI-003
Meniere's Disease |
Famvir |
December 2011 |
January 2015 |
March 2015 |
February 3, 2012 |
August 28, 2015 |
|
|
| 14 |
NCT02265393 |
Completed |
A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom |
|
- Drug: OTO-104
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Safety
- Meniere's Symptom Questionnaire
|
128 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02265393 |
104-201403 |
|
October 2014 |
May 2016 |
May 2016 |
October 15, 2014 |
August 18, 2017 |
|
- Heatherwood & Wexham Park Hospitals
Berkshire, United Kingdom - Birmingham University Hospital
Birmingham, United Kingdom - BMI The Edgbaston Hospital
Birmingham, United Kingdom - (and 12 more...)
|
| 15 |
NCT01412177 |
Completed |
OTO-104 for the Treatment of Meniere's Disease |
|
- Drug: OTO-104
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Reduction in vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease
- Evaluation of adverse events, otoscopic exams, audiometry, Word Recognition Score and tympanometry as a measure of safety and tolerability
- Evaluation of tinnitus patient reported questionnaire and daily diary as a measure of impact of tinnitus on activities of daily living
- Evaluation of patient reported questionnaires as a measure of impact on patient daily activities
|
154 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT01412177 |
104-201102 |
|
November 2013 |
March 2015 |
April 2015 |
August 9, 2011 |
September 3, 2015 |
|
- Many sites in US and Canada. Refer to the contact info listed below.
San Diego, California, United States - UC Health Otolaryngology - Head and Neck Surgery
Cincinnati, Ohio, United States
|
| 16 |
NCT01084525 |
Completed |
OTO-104 for Meniere's Disease |
|
- Drug: OTO-104 (steroid) 3 mg
- Drug: Placebo
- Drug: OTO-104 (steroid) 12 mg
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The primary objective of this study is to evaluate the safety and tolerability of two ascending OTO-104 doses relative to placebo. Safety assessments will be performed for 3 months post single intratympanic injection of OTO-104 or placebo.
- The secondary objective of this study is to evaluate the clinical activity of two OTO-104 doses relative to placebo. Change in baseline for vertigo frequency will be evaluated with descriptive statistics.
- The impact of tinnitus on activities of daily living will be measured.
- (and 3 more...)
|
44 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01084525 |
104-200901 |
|
March 2010 |
March 2011 |
April 2011 |
March 10, 2010 |
June 8, 2011 |
|
- House Ear Institute
Los Angeles, California, United States - University of California, San Diego
San Diego, California, United States - Colorado Otolaryngology Associates
Colorado Springs, Colorado, United States - (and 12 more...)
|
| 17 |
NCT00160238 |
Completed |
Effects of Betaserc on Vestibular Compensation in Patients Suffering From Disabling Meniere's Disease and Having Undergone Vestibular Neurotomy |
|
- Drug: Betahistine 24 mg bid (Betaserc)
|
Interventional |
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Patients who have undergone vestibular neurotomy for the treatment of disabling Menière’s disease and who have confirmed vestibular areflexia
- Other peripheral vestibular disease than Menière’s disease;Central vestibular disease; Neurological disease; Contraindication to betahistine; Pregnant or lactating women
|
20 |
All |
18 Years to 65 Years (Adult) |
NCT00160238 |
S108.4.102 |
|
January 2003 |
|
|
September 12, 2005 |
December 22, 2006 |
|
|
| 18 |
NCT00599560 |
Completed |
Vasopressin and V2 Receptor in Meniere's Disease |
|
- Genetic: vasopressin, V2 receptor and cyclic AMP
|
Interventional |
Not Applicable |
- Osaka University
- Osaka City University
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- plasma vasopressin level and V2 receptor mRNA in the endolymphatic sac in Meniere's disease vs controls
- cyclic AMP activity in the endolymphatic sac in Meniere's disease vs controls
|
135 |
All |
20 Years to 80 Years (Adult, Senior) |
NCT00599560 |
tk19661218
Osaka Univ. School of Medicine |
|
April 1998 |
September 2005 |
September 2005 |
January 23, 2008 |
March 29, 2016 |
|
- Department of Otolaryngology, Osaka University, School of Medicine
Suita-city, Osaka, Japan
|
| 19 |
NCT00500474 |
Completed |
Effects of Endolymphatic Sac Drainage With Steroids for Meniere’s Disease |
|
- Procedure: endolymphatic sac drainage with steroids
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single
- Primary Purpose: Treatment
|
- the ratio of patients in vertigo supression and hearing improvement
- the ratio of patients in canal improvement
|
197 |
All |
Child, Adult, Senior |
NCT00500474 |
tk19661217
tk20090401 |
EDSS |
April 1996 |
|
March 2005 |
July 12, 2007 |
July 25, 2007 |
|
- Department of Otolaryngology, Osaka University, School of Medicine
Suita-city, Osaka, Japan
|
| 20 |
NCT00831688 |
Completed |
Efficacy of Local Overpressure Treatment for Meniere's Disease |
|
- Device: Meniett(C) device by MedTronic
- Device: placebo treatment
|
Interventional |
Phase 4 |
- Klinikum der Universitaet Muenchen, Grosshadern
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change in vertigo score from pre-therapy to post-therapy. (Vertigo score = summation of daily vertigo severity over 4 weeks. Daily vertigo score = a number between = and 4.)
- Pure tone audiometric thresholds
- Speech recognition hearing levels
- (and 2 more...)
|
80 |
All |
18 Years and older (Adult, Senior) |
NCT00831688 |
Meniere trial 037/05 |
|
August 2005 |
April 2009 |
April 2009 |
January 29, 2009 |
April 21, 2009 |
|
- Klinik für Hals-Nasen-Ohrenheilkunde
München, Bayern, Germany
|
| 21 |
NCT01729767 |
Unknown † |
Efficacy of Antiviral Medications in Controlling Vertigo Attacks of Patients With Meniere's Disease |
|
- Drug: Acyclovir
- Drug: Placebo
|
Interventional |
Phase 2
Phase 3 |
- Tehran University of Medical Sciences
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Vertigo
- Hearing Loss
- Aural Fullness
- Tinnitus
|
80 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT01729767 |
88-03-48-9453 |
|
August 2011 |
December 2012 |
|
November 20, 2012 |
November 20, 2012 |
|
- Amiralam Hospital
Tehran, Iran, Islamic Republic of
|
| 22 |
NCT00145483 |
Completed |
Sildenafil For Meniere's Disease |
|
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Vertigo Response (4 x 6 point scale); Balance (6 point scale)
- Hearing/Tinnitus; Ear, Nose & Pressure/Fullness; Perf. daily activities; Nausea; Vomiting; Func. Response; Duration of the Attack and Vertigo; Rescue Medications Use; Acceptability to subject; Composite Assessment Score; Comparison to Previous Attack
|
180 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT00145483 |
A1481107 |
|
June 2002 |
|
|
September 5, 2005 |
January 31, 2008 |
|
- Pfizer Investigational Site
Bondi Junction, New South Wales, Australia - Pfizer Investigational Site
Brisbane, Queensland, Australia - Pfizer Investigational Site
East Melbourne, Victoria, Australia - Pfizer Investigational Site
Melbourne, Victoria, Australia
|
| 23 |
NCT01099046 |
Recruiting |
Stress Management Therapy for Meniere's Disease |
|
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
|
200 |
All |
Child, Adult, Senior |
NCT01099046 |
yk19700512 |
SMT |
January 2009 |
January 2015 |
January 2020 |
April 6, 2010 |
April 6, 2010 |
|
- Department of Otolaryngology, Osaka University, School of Medicine
Suita-city, Osaka, Japan
|
| 24 |
NCT02718846 |
Completed |
Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets |
|
- Drug: Meniace
- Drug: Isobide
|
Interventional |
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- the number of vertigo episodes
|
220 |
All |
20 Years to 80 Years (Adult, Senior) |
NCT02718846 |
KW-ISOBIDE_P4 |
|
February 2013 |
May 2015 |
May 2015 |
March 24, 2016 |
March 24, 2016 |
|
|
| 25 |
NCT01574313 |
Completed |
Effect of Stellate Ganglion Block on Meniere's Disease |
|
- Procedure: stellate ganglion block
- Drug: 0.25mg, fludiazine
- Drug: 25mg cephadol@ (diphenidol)
- Drug: 200mg kentons@ (tocopherol nicotinate).
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- SP/AP of Electrocochleography
- SP/AP recorded at 4 hours after SGB
- SP/AP recorded at 6 hours after SGB
- scores of verbal scale for vertigo recorded at 6 hours after SGB
|
20 |
All |
30 Years to 65 Years (Adult) |
NCT01574313 |
SGB09804-003
CMH09804-003 |
|
April 2010 |
April 2011 |
March 2012 |
April 10, 2012 |
April 11, 2012 |
|
- i Mei Medical Center Tainan, Taiwan, Taiwan
Tainan, Taiwan
|
| 26 |
NCT02080312 |
Completed
Has Results |
Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent |
|
- Drug: Magnevist (gadopentetate dimeglumine)
|
Interventional |
Not Applicable |
- University of California, San Diego
- American Society of Head and Neck Radiology
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Vestibular "Endolymphatic Hydrops (EH)"
- Cochlear "Endolymphatic Hydrops (EH)"
- Extension of Contrast From Perilymph to CSF
|
6 |
All |
18 Years and older (Adult, Senior) |
NCT02080312 |
120004
115,342 |
|
January 2012 |
December 2013 |
December 2013 |
March 6, 2014 |
February 12, 2016 |
February 12, 2016 |
- UC San Diego Health System
San Diego, California, United States
|
| 27 |
NCT02529475 |
Recruiting |
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS) |
|
|
Interventional |
Phase 4 |
- University Hospital, Grenoble
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted Imaging
|
40 |
All |
40 Years and older (Adult, Senior) |
NCT02529475 |
38RC14.428 |
HYDROPS |
February 2016 |
September 2018 |
June 2019 |
August 20, 2015 |
March 29, 2018 |
|
- GrenobleUniversityHospital
Grenoble, France
|
| 28 |
NCT02158585 |
Completed |
Study of Lamotrigine to Treat Ménière's Disease |
- Meniere's Disease
- Ménière's Vertigo
- Vertigo, Intermittent
- Vertigo, Aural
|
- Drug: Lamotrigine
- Drug: Placebo
|
Interventional |
Phase 3 |
- Dent Neuroscience Research Center
- University at Buffalo
- Ernesto Diaz-Ordaz, MD
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Ménière's vertigo attack frequency
- Responder rate
- Change in length of vertigo attack-free intervals
- (and 10 more...)
|
24 |
All |
18 Years and older (Adult, Senior) |
NCT02158585 |
Zhang-001 |
|
June 2014 |
March 2017 |
March 2017 |
June 9, 2014 |
July 28, 2017 |
|
- Dent Neurologic Institute
Amherst, New York, United States
|
| 29 |
NCT02309099 |
Completed |
Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach |
- Unilateral Acoustic Neuroma
- Meniere's Disease
|
|
Interventional |
Not Applicable |
- University of North Carolina, Chapel Hill
- Med-El Corporation
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Speech perception testing
- Sound localization testing
- Subjective questionnaires to indicate perceived benefits of cochlear implantation
- (and 3 more...)
|
10 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT02309099 |
14-1818 |
|
November 2014 |
November 8, 2017 |
November 8, 2017 |
December 5, 2014 |
January 9, 2018 |
|
- University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
|
| 30 |
NCT03215420 |
Recruiting |
Comparison of 3 Methods to Diagnose Endolymphatic Hydrops in Meniere's Disease |
|
|
Interventional |
Not Applicable |
- Centre Hospitalier Universitaire Dijon
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Number of patients for whom an endolymphatic hydrops was diagnosed by electrocochleography
- Number of patients for whom an endolymphatic hydrops was diagnosed by (Dephasing) of acoustic distortion products
- Number of patients for whom an endolymphatic hydrops was diagnosed by 3T MRI 3T
|
43 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03215420 |
DIORFLAR- BOZORG 2016 |
MRI Meniere |
September 8, 2016 |
March 8, 2019 |
September 8, 2019 |
July 12, 2017 |
October 10, 2017 |
|
- CHu Dijon Bourgogne
Dijon, France
|
| 31 |
NCT01759251 |
Completed
Has Results |
Effectiveness of Betaserc® (Betahistine Dihydrochloride) in Patients With Vestibular Vertigo in Routine Practice |
|
|
Observational |
|
|
Industry |
- Time Perspective: Prospective
|
- Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)
- Change of the Patient's Clinical Conditions of Vestibular Vertigo From Baseline to the End of Observational Treatment Period
- Change of Vestibular Vertigo Attacks Frequency From Baseline to the End of Observational Treatment Period
- (and 5 more...)
|
309 |
All |
18 Years and older (Adult, Senior) |
NCT01759251 |
P13-972 |
VIRTUOSO |
January 2013 |
May 2014 |
May 2014 |
January 3, 2013 |
February 27, 2015 |
February 27, 2015 |
- Site reference ID 89414
Belgorod, Russian Federation - Research facility ID ORG-000838
Irkutsk, Russian Federation - Site reference ID 89433
Kazan, Russian Federation - (and 21 more...)
|
| 32 |
NCT01950312 |
Completed |
The Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease |
- Autoimmune Inner Ear Disease
|
|
Interventional |
Phase 2 |
- XOMA (US) LLC
- Feinstein Institute for Medical Research
- National Institute on Deafness and Other Communication Disorders (NIDCD)
|
Industry / Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Improved hearing threshold, as defined by an improvement in either the PTA (Pure Tone Average) of >=5 dB (Decibel), or 12% in the WRS (Word Recognition Score)
|
10 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01950312 |
X052180
R33DC011827 |
|
August 2013 |
October 2015 |
December 2015 |
September 25, 2013 |
February 3, 2016 |
|
- Long Island Jewish Medical Center, Hearing & Speech Center
New Hyde Park, New York, United States
|
| 33 |
NCT01267994 |
Completed
Has Results |
A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease |
- Sensorineural Hearing Loss
- Autoimmune Inner Ear Disease
|
|
Interventional |
Phase 1
Phase 2 |
- Andrea Vambutas
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Northwell Health
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease
- Number of Serious Adverse Events Reported
|
13 |
All |
13 Years to 75 Years (Child, Adult, Senior) |
NCT01267994 |
1R21DC011827-01
R33DC011827 |
|
June 2011 |
September 2014 |
September 2014 |
December 29, 2010 |
January 10, 2018 |
April 6, 2015 |
- North Shore-LIJ Hearing and Speech Center
New Hyde Park, New York, United States
|
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