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Trial record 1 of 1 for:    SENS-111
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Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy

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ClinicalTrials.gov Identifier: NCT03110458
Recruitment Status : Completed
First Posted : April 12, 2017
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Sensorion

Tracking Information
First Submitted Date  ICMJE March 27, 2017
First Posted Date  ICMJE April 12, 2017
Last Update Posted Date May 13, 2020
Actual Study Start Date  ICMJE April 12, 2017
Actual Primary Completion Date October 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2017)
Standing vertigo intensity [ Time Frame: Up to 28 days ]
By Visual analogue scale (VI-VAS)
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
Standing vertigo intensity [ Time Frame: Twice daily during 28 days ]
The primary endpoint is the vertigo intensity measured by the AUC of the Vertigo Intensity Visual Analogue Scale (VI-VAS) in standing position over the 4 treatment days (8 post baseline assessments)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2017)
  • Worst spontaneous vertigo intensity [ Time Frame: Up to 28 days ]
    By Visual analogue scale
  • Proprioception [ Time Frame: Up to 28 days ]
    By the score of the Romberg tests
  • Vestibular spontaneous nystagmus [ Time Frame: Up to 28 days ]
    By oculography
  • Nausea severity [ Time Frame: Up to 28 days ]
    By Visual Analogue Scale
  • Safety [ Time Frame: Up to 28 days ]
    By the incidence of adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
  • Worst spontaneous vertigo intensity [ Time Frame: over the 4 treatment days (8 post baseline assessments) ]
    The Worst spontaneous vertigo intensity measured by the AUC of the worst vertigo visual analogue scale (VI-VAS)
  • Proprioception [ Time Frame: At the end of the treatment (D5) and end of study (D28) ]
    Change from baseline of the total score of the Romberg tests
  • Vestibular spontaneous nystagmus [ Time Frame: At the end of the treatment (D5) and end of study (D28). ]
    Peak slow phase velocity of the peripheral vestibular spontaneous nystagmus, measured by oculography in darkness
  • Nausea severity [ Time Frame: over the 4 treatment days (8 post baseline assessments) ]
    Nausea severity measured by the AUC of the Nausea Intensity Visual Analogue Scale
  • The functional disability [ Time Frame: at D1 and at the end of study (D28) ]
    The functional disability assessed by the Dizziness Handicap Inventory (DHI) functional subscale score
  • The functional disability [ Time Frame: at the end of study (D28) ]
    The functional disability assesses also by the Vestibular Disorders Activities of Daily Living Scale (VADL)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy
Official Title  ICMJE A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 2 Dose Regimens of Orally Administered SENS-111 (100 mg and 200 mg) Given During 4 Days in Patients Suffering From Acute Unilateral Vestibulopathy
Brief Summary A multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 2 dose-regimens of orally administered SENS-111 (100mg and 200mg) given during 4 days in patients suffering from Acute Unilateral Vestibulopathy (AUV)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Unilateral Vestibulopathy (AUV)
Intervention  ICMJE
  • Drug: SENS-111 100mg
    2 ODT (1 ODT SENS-111 and 1 ODT placebo)
  • Drug: SENS-111 200mg
    2 ODT (2 ODT SENS-111)
  • Drug: Placebo Oral Tablet
    2 ODT (2 ODT placebo)
Study Arms  ICMJE
  • Experimental: SENS-111 100mg
    SENS-111 100mg: 2ODT (1 ODT SENS-111 and 1 ODT placebo)
    Intervention: Drug: SENS-111 100mg
  • Experimental: SENS-111 200mg
    SENS-111 200mg: 2 ODTs SENS-111
    Intervention: Drug: SENS-111 200mg
  • Placebo Comparator: Placebo
    Placebo: 2 placebo ODTs
    Intervention: Drug: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2020)
107
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2017)
207
Actual Study Completion Date  ICMJE October 15, 2019
Actual Primary Completion Date October 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria includes, but is not limited to:

* Subject has a diagnosis of definite Acute Unilateral Vestibulopathy

Exclusion criteria includes, but is not limited to:

  • Acute continuous vertigo lasting more than 72 hours prior to randomization
  • History of acute or chronic vestibular diseases
  • History of prior acute central vestibular lesion
  • Acute or chronic disease of middle ear
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03110458
Other Study ID Numbers  ICMJE SENS 111-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sensorion
Study Sponsor  ICMJE Sensorion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael STRUPP, MD University Hospital Munich
PRS Account Sensorion
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP