acute_unilateral_vestibulopathy_clinical_trial_feasibility_credevo

Acute vestibulopathy is characterized by an acute or subacute onset of vertigo, dizziness, or imbalance with or without ocular motor, sensory, postural or autonomic symptoms, and signs, and can last for seconds to up to several days.

acute_unilateral_vestibulopathy_clinical_trial_feasibility_credevo

What is Acute Unilateral Vestibulopathy?

Normal vestibular end organs generate an equal resting-firing frequency of the axons, which is the same on both sides under static conditions. An acute unilateral vestibulopathy leads to a vestibular tone imbalance.

What Are Acute Unilateral Vestibulopathy Symptoms?

  • Acute onset of spinning vertigo and oscillopsia are the hallmarks of acute unilateral vestibulopathy. In addition, the patients have a postural imbalance, a tendency to fall to the affected side, and suffer from nausea and vomiting.
  • Key signs and symptoms are acute onset of spinning vertigo, postural imbalance, and nausea as well as horizontal rotatory nystagmus beating towards the non-affected side, a pathological head-impulse test, and no evidence for the central vestibular or ocular motor dysfunction.
  • Acute unilateral vestibulopathy is defined by the patient’s history and clinical examination and, in unclear cases, laboratory examinations.

What is the Prevalence of Acute Unilateral Vestibulopathy (AUV)?

  • Acute Unilateral Vestibulopathy is widely considered a rare condition.
  • Currently, there’s not enough data on the prevalence of Acute Unilateral Vestibulopathy. For a year, the incidence of AUV between 3.5 and 15.5 per 100,000 persons was described. Acute Unilateral Vestibulopathy accounts for about 8% of patients with vertigo, which also happens to children.
  • The age distribution plateaus are between 40 and 50 years, and there is no gender difference. The recurrence rate varies between 1.9% and 10.7%.

What are available treatments for Acute Unilateral Vestibulopathy?

The management of acute unilateral vestibulopathy involves

  1. Symptomatic treatment with antivertiginous drugs (eg, meclizine, dimenhydrinate, scopolamine, or in severe cases benzodiazepines) to attenuate vertigo, dizziness, and nausea/vomiting,
  2. Causal treatment with corticosteroids to improve recovery of peripheral vestibular function; and
  3. Physical therapy (vestibular exercises and balance training) to improve central vestibular compensation.

Vestibular Physical Therapy is a gradual program of physical exercise under the supervision of a physiotherapist.

Clinical Trials in Acute Unilateral Vestibulopathy?

Interestingly, a search on clinicaltrials.gov does not come up with many clinical trials in Acute Unilateral Vestibulopathy. There are only two clinical trials listed on clinicaltrials.gov and both of these are in Europe.

  1. Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy
  2. Acute Unilateral Vestibulopathy and Corticosteroid Treatment
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However, including the term “vestibular neuritis” in the search indicates 20 clinical trials in this segment. It can be noted that sometimes, vestibular neuritis has been used to indicate Acute Unilateral Vestibulopathy.

In the European clinical trial register, there were 4 clinical trials found in the search. These clinical trials include found in clinicaltrials.gov as well as the famous BETAVEST clinical trial.

BETAVEST clinical trial involved investigations on the effects of betahistine on central compensation in acute unilateral vestibulopathy (betahistine-dihydrochloride, 48 mg thrice a day, vs placebo; the BETAVEST trial), which focuses on postural imbalance, spontaneous nystagmus, and functional impairment.

Clinical Trial Feasibility in Acute Unilateral Vestibulopathy

Clinical trial feasibility for Acute Unilateral Vestibulopathy has been performed on Credevo.

Phase of the trial

This clinical trial was a phase 2/3 trial in adults with Acute Unilateral Vestibulopathy (AUV).

Investigational drug

The drug under investigation in this clinical trial was an antagonist of the histamine H4 receptor. It was developed as a potential novel therapy for patients suffering from AUV with the aim of improving associated symptoms without preventing long term recovery.

Previous data

Previous data included Phase 1 data from 4 clinical studies with safety established. The drug was well tolerated and the maximally tolerated dose was not reached. No dose-dependent adverse event was observed. There were no cardiac or mutagenic effects.

Sites and region

Total 3 sites from Australia were required in this clinical trial.

Therapeutic area

Investigators and sites with capability and expertise in neurology and otolaryngology have been explored for this clinical trial.


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References

  1. Acute vestibulopathy. Strupp M1, Arbusow V.; Curr Opin Neurol. 2001 Feb;14(1):11-20.
  2. Strupp, Michael & Magnusson, Måns. (2015). Acute Unilateral Vestibulopathy. Neurologic clinics. 33. 669-685. 10.1016/j.ncl.2015.04.012.
  3. Acute unilateral vestibulopathy (“vestibular neuritis”)
  4. Clinical trial feasibility in Acute Unilateral Vestibulopathy on Credevo