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Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy (SENS 111-201)

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ClinicalTrials.gov Identifier: NCT03110458
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : July 2, 2017
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 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 207 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 : April 12, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SENS-111 100mg
SENS-111 100mg: 2ODT (1 ODT SENS-111 and 1 ODT placebo)
Drug: SENS-111 100mg
2 ODT (1 ODT SENS-111 and 1 ODT placebo)

Experimental: SENS-111 200mg
SENS-111 200mg: 2 ODTs SENS-111
Drug: SENS-111 200mg
2 ODT (2 ODT SENS-111)

Placebo Comparator: Placebo
Placebo: 2 placebo ODTs
Drug: Placebo Oral Tablet
2 ODT (2 ODT placebo)




Primary Outcome Measures :
  1. Standing vertigo intensity [ Time Frame: Up to 28 days ]
    By Visual analogue scale (VI-VAS)


Secondary Outcome Measures :
  1. Worst spontaneous vertigo intensity [ Time Frame: Up to 28 days ]
    By Visual analogue scale

  2. Proprioception [ Time Frame: Up to 28 days ]
    By the score of the Romberg tests

  3. Vestibular spontaneous nystagmus [ Time Frame: Up to 28 days ]
    By oculography

  4. Nausea severity [ Time Frame: Up to 28 days ]
    By Visual Analogue Scale

  5. Safety [ Time Frame: Up to 28 days ]
    By the incidence of adverse events



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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


Contacts
Contact: Mélina BLAIRVACQ, CRA +33 4 34 08 71 17 melina.blairvacq@sensorion-pharma.com

Locations
Germany
STRUPP Recruiting
Munich, Germany
Sponsors and Collaborators
Sensorion
Investigators
Principal Investigator: Michael STRUPP, MD University Hospital Munich

Responsible Party: Sensorion
ClinicalTrials.gov Identifier: NCT03110458     History of Changes
Other Study ID Numbers: SENSORION
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017

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