A study investigating the safety and effectiveness of intranasal betahistine in patients suffering from vertigo (giddiness) after the removal of a tumor of the balance and hearing nerve

Phase 1

Active, not recruiting

• Conditions: Treatment of acute peripheral vertigo; MedDRA version: 20.0Level: LLTClassification code 10059614Term: Vestibular vertigoSystem Organ Class: 100000004854; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-002474-52-IT
• Lead Sponsor: Auris Medical Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-21
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

Subjects have to meet all of the following inclusion criteria to be eligible for enrolment into the study:
1. Scheduled for neurosurgery (vestibular schwannoma resection, labyrinthectomy or vestibular neurectomy)
2. Small to moderately large vestibular schwannoma (Koos grade I-III; Samii grade T1-T3b; = 30 mm in diameter in cerebellopontine angle) that does not displace the brainstem, documented by magnetic resonance imaging not older than six months.
or
Indication for labyrinthectomy or vestibular neurectomy.
3. Confirmed vestibular function on both sides (> 6 deg/sec sum of bithermal max. slow phase velocity on the affected side in caloric video/electronystagmography (VNG/ENG) and > 10 deg/sec sum of bithermal max. slow phase velocity on the contralateral side).
4. Presence of symptoms of acute peripheral vertigo:
• Subjective symptoms of vertigo (rating of at least two in EEV questionnaire question 1: illusion of movement)
• Spontaneous nystagmus beating towards the contralateral side. SVV deviation > 2.5°from the true vertical.
5. Age at SV (screening visit) =18 years and =70 years.
6. Negative urine pregnancy test for women of childbearing potential.
7. Willing and able to attend the study visits.
8. Able to read and understand study documents, to complete the relevant questionnaires and rating scales and follow Investigator instructions.
9. Signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

1. Prior radiotherapy (gamma knife, intensity modulated radiation therapy) irradiating the brain-stem with more than 4 Gy.
2. Any ongoing other peripheral vestibular disorder (e.g. Meniere's disease, benign paroxysmal vertigo, vestibular neuritis) or central vestibular disorder (e.g. vestibular migraine, central vertigo).
3. Vestibular rehabilitation therapy or presurgical gentamicin therapy (i.e. pre-habilitation therapy) within the past three months prior to neurosurgery.
4. Any clinically relevant nasal obstruction or pathology precluding effective and/or safe intranasal delivery.
5. Diagnosis of phaeochromocytoma.
6. Ongoing upper respiratory tract infection or allergic rhinitis (symptomatic).
7. Any treatment with antihistamines, anti-emetics or benzodiazepines that is ongoing or planned during the IMP treatment period.
8. Any history of clinically relevant drug hypersensitivity, urticaria, or other severe allergic diathesis as well as current moderate or severe allergic disorders or hay fever.
9. Subjects with diagnosed anxiety disorders, depression, schizophrenia or other significant psychiatric diseases requiring current drug treatment or subjects who required treatment in the previous three months prior to
enrolment for any of these diseases.
10. Any clinically relevant respiratory, cardiovascular, neurological disorder (e.g. neurofibromatosis type 2, except vertigo), relevant orthopaedic or visual limitation, relevant abnormality in laboratory test or physical examination or other abnormality that in the opinion of the Investigator or Sponsor may pose a safety risk to a subject in this study, which may confound efficacy or safety assessment, or may interfere with study participation.
11. Any clinically relevant complication during or after neurosurgery that in the opinion of the Investigator or Sponsor may pose a safety risk to a subject in this study, which may confound efficacy or safety assessment, or may interfere with study participation.
12. Known hypersensitivity, allergy or intolerance to the study medication or any history of severe, abnormal drug reaction.
13. History within the past two years or presence of drug abuse or alcoholism.
14. Women who are breast-feeding, pregnant or who are planning to become pregnant during the study.
15. Women of childbearing potential who are unwilling or unable to use an effective method of avoiding pregnancy from the SV until the end of the study. Effective methods of avoiding pregnancy are contraceptive methods with a Pearl index of less than 1 used consistently and correctly (including implantable, injectable, oral and transdermal contraceptives, intrauterine devices, or a sterile sexual partner, or being abstinent).
16. Concurrent treatment with another investigational medicinal product or prior treatment with another investigational medicinal product within
30 days prior to randomization.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified