Effects of betahistine on the symptoms of the balance system failure

• Conditions: vestibular failure (vestibular neuritis); MedDRA version: 18.0Level: PTClassification code 10047386Term: Vestibular disorderSystem Organ Class: 10013993 - Ear and labyrinth disorders; MedDRA version: 18.0Level: PTClassification code 10029240Term: NeuritisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2009-013702-14-DE
• Lead Sponsor: Hospital of the University of Munich

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-05
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Patients male or female who are at least 18 years old
•patient has a history of acute/sub-acute (i.e., within minutes to hours) onset of severe prolonged rotatory vertigo, nausea, and postural imbalance;
•the clinical examination reveals horizontal-rotatory spontaneous nystagmus (fast phase) toward the unaffected ear without evidence of a central vestibular lesion, and a pathological head-impulse test (i.e., turning the head of the patient rapidly to the right and left while observing provoked compensatory eye movements) that reveals an ipsilateral deficit of the horizontal semicircular canal (Halmagyi & Curthoys 1988);
•caloric irrigation shows hypo-/unresponsiveness of the horizontal canal of the affected ear, i.e., the maximum slow phase velocity during caloric irri-gation with 30°C and 44°C water should be less than 3°/s on the affected side and the asymmetry between the two sides is >25 percent according to Jongkees’s vestibular paresis formula” (Jongkees et al. 1962; Fife et al. 2000); and
•there is a displacement of the subjective visual vertical toward the affected ear without any vertical divergence of the eyes, i.e., without vertical deviation of one eye above the other (Cnyrim et al. 2008).
•Written 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients not able to give consent
•a history of vestibular dysfunction before the acute symptom onset or vestibular symptoms beginning more than 3 days before patients were re-cruited;
•additional cochlear symptoms, i.e., tinnitus or acute hearing loss before, during, or after the onset of vertigo;
•central ocular motor or central vestibular dysfunction;
•any other brainstem or cerebellar signs or symptoms or abnormal findings on the MRI in the brainstem or cerebellum in diffusion-weighted images or hyperintense lesions in T2-weighted images in combination with contrast enhancement in T1-weighted images;
•other known vestibular disorders such as vestibular migraine, Menière´s disease/syndrome, phobic postural vertigo, benign paroxysmal po-sitioning vertigo;
•central disorders such as paroxysmal brainstem attacks;
•contraindications for treatment with betahistine-dihydrochloride as bron-chiale asthma, pheochromocytoma,
•pregnancy or breast-feeding,
•severe dysfunction of liver or kidney, ulcer of the stomach or duodenum,
•treatment with other antihistaminic drugs;
•known severe coronary heart disease or heart failure,
•persistent hypertension with systolic blood pressure > 180 mmHg or diastolic BP > 110 mmHg that cannot be controlled by antihypertensive thera-py,
•life expectancy < 3 months, other serious illness, e.g., severe hepatic, cardiac or renal failure, acute myocardial infarction, neoplasm or a com-plex disease that may confound treatment assessment.
•The patient has received any investigational medication within 30 days prior to administration of trial medication or is scheduled to receive an in-vestigational drug up to 30 days after end of trial
•The patient was previously admitted to this trial or simultaneous participa-tion in another clinical trial or participation in any clinical trial involving an administration of investigational medicinal product within 30 days prior to clinical trial beginning.

Study & Design

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