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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
Results First Posted : October 27, 2020
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
Sensorion

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)

Condition or disease Intervention/treatment Phase
Acute Unilateral Vestibulopathy (AUV) Drug: SENS-111 100mg Drug: SENS-111 200mg Drug: Placebo Oral Tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 16, 2017
Actual Primary Completion Date : October 15, 2019
Actual Study Completion Date : October 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SENS-111 100mg
SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)
Drug: SENS-111 100mg
SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.

Experimental: SENS-111 200mg
SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)
Drug: SENS-111 200mg
SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.

Placebo Comparator: Placebo
Placebo: 2 placebo Oral Dispersible Tablets
Drug: Placebo Oral Tablet
Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.




Primary Outcome Measures :
  1. Standing Vertigo Intensity [ Time Frame: over the 4 treatment days ]

    The primary efficacy endpoint was the Area Under Curve (AUC) for the vertigo intensity measured by the Vertigo Intensity Visual Analogue Scale (VI-VAS) in standing position over the 4 treatment days (8 post-baseline assessments).

    The vertigo Intensity VAS is a non-anchored 10cm horizontal line. Patients were asked to rate the intensity of their vertigo making a vertical mark crossing the horizontal 10 cm line to indicate the severity from 0-100 when 0 indicates no severity and 100 indicates worse severity.



Secondary Outcome Measures :
  1. Worst Spontaneous Vertigo Intensity [ Time Frame: over the 4 treatment days ]

    Worst spontaneous vertigo intensity measured by the AUC of the worst Vertigo Intensity Visual Analogue Scale (VI-VAS) over the 4 treatment days (8 post-baseline assessments).

    The vertigo Intensity VAS is a non-anchored 10cm horizontal line. Patients were asked to rate the intensity of their vertigo making a vertical mark crossing the horizontal 10 cm line to indicate the severity from 0-100 when 0 indicates no severity and 100 indicates worse severity


  2. Proprioception D5 [ Time Frame: End of treatment Day 5 ]
    The Romberg test assess the patient's ability to stand unassisted under 6 successive test conditions of increasing difficulty. In this test higher values are indicating a higher ability to stand unassisted, minimum total score is : 0 (impossibility to stand unassisted in any of the six conditions) and maximum is: 6. The change from Baseline of the total score of the six conditions of the Romberg test at the end of treatment (EOT) (Day 5) is evaluated.

  3. Proprioception D28 [ Time Frame: End of study Day 28 ]
    The Romberg test assess the patient's ability to stand unassisted under 6 successive test conditions of increasing difficulty. In this test higher values are indicating a higher ability to stand unassisted, minimum total score is : 0 (impossibility to stand unassisted in any of the six conditions) and maximum is: 6. Change from Baseline of the total score of the six conditions of the Romberg test at the end of study (EOS) (Day 28) is evaluated.

  4. Vestibular Spontaneous Nystagmus D5 [ Time Frame: End of treatment Day 5 compared to basleine ]
    Change from Baseline of the Peak Slow Phase Velocity of the Peripheral Vestibular Spontaneous Nystagmus at the end of treatment (EOT) (Day 5). It is intended to record eye movements resulting from Nystagmus, measured by Oculography performed in complete darkness with visual fixation (10 seconds) or without fixation (30 seconds).

  5. Vestibular Spontaneous Nystagmus D28 [ Time Frame: 28 days compared to baseline ]
    Change from Baseline of the Peak Slow Phase Velocity of the Peripheral Vestibular Spontaneous Nystagmus at End of Study (Day 28). It is intended to record eye movements resulting from Nystagmus, measured by Oculography performed in complete darkness with visual fixation (10 seconds) or without fixation (30 seconds).

  6. Nausea Severity [ Time Frame: over the 4 Treatment Days (Day 5) ]

    Nausea Severity measured by the Area under the Curve of the Nausea Intensity Visual Analogue Scale (NI-VAS).

    Patients were asked to rate the intensity of their nausea making a vertical mark crossing the horizontal 10 cm line to indicate the severity from 0-100 when 0 indicates no severity and 100 indicates worse severity.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110458


Locations
Show Show 24 study locations
Sponsors and Collaborators
Sensorion
Investigators
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Principal Investigator: Michael STRUPP, MD University Hospital Munich
  Study Documents (Full-Text)

Documents provided by Sensorion:
Statistical Analysis Plan  [PDF] November 12, 2019
Study Protocol  [PDF] February 9, 2017

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Responsible Party: Sensorion
ClinicalTrials.gov Identifier: NCT03110458    
Other Study ID Numbers: SENS 111-201
First Posted: April 12, 2017    Key Record Dates
Results First Posted: October 27, 2020
Last Update Posted: October 27, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sensorion:
Acute unilateral vestibulopathy, AUV
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms