Clinical trial NCT05897853: Impact of Vertigoheel® on Patients Suffering From Bilateral Vestibulopathy and Functional Dizziness
Official title: Impact of Vertigoheel® on Patients Suffering From Bilateral Vestibulopathy and Functional Dizziness in a Real-world Setting, Using PRO and QoL - a Non-interventional, Prospective, Mono-center, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vertigo
Functional Dizziness
Bilateral Vestibulopathy
Keywords: real world evidence
non-interventional study
patient reported outcome
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients, aged ≥18 years old, diagnosed with bilateral vestibulopathy or functional dizziness were recruited from the Department of Neurology at the Hospital of the Ludwig-Maximilians-University Munich.

Brief summary: In this study the researcher observe how vertigo symptoms change during two months of treatment with the natural medicinal product Vertigoheel©. Adult patients suffering from vertigo symptoms can participate if they are diagnosed with bilateral vestibulopathy (BVP) or functional dizziness (FD) and assigned to Vertigoheel treatment. Participating patients receive an examination at study start and after 2 months of Vertigoheel treatment. The study focuses on patient reported outcomes assessed by questionnaires.

Vertigo symptoms are assessed by the Dizziness Handicap Inventory questionnaire. Patients' quality of life is assessed by a questionnaire. Body sway is assessed by static posturography. FD patients are additionally tested for depressive and anxiety symptoms by questionnaires. BVP patients are additionally tested for vestibular function by video head impulse test and caloric testing. Adverse events and other observations related to safety (physical examination and vital signs) are evaluated.

Vertigo is a common symptom with significant adverse effects on patients' quality of life. Regardless of the exact cause of vertigo attacks, it is important to reduce the frequency, intensity, and duration of vertigo attacks with an effective medication that has no or minimal adverse effect. Vertigoheel®, a natural medicinal product consisting of four ponderable active ingredients, is approved in Germany as treatment for vertigo of various origins. However, no systematic data are available for Vertigoheel® regarding patient-reported outcomes in BVP and FD as the most accepted endpoint in vertigo studies.


Eligibility criteria: Inclusion Criteria:

* Treatment with Vertigoheel® has been chosen by the physician independently of including the patient in this non-interventional study.
* Bilateral vestibulopathy or functional dizziness according to the current diagnostic criteria of the Bárány Society
* Symptoms for \> 3 months of moderate to severe intensity according to the dizziness handicap inventory \[0 (minimum score) -100 (maximum score)\] between 30 to 90 points.
* ≥18 years of age
* Legally competent male or female outpatient.
* Signed informed consent.
* Not pregnant (as proven by negative pregnancy test in case of woman of childbearing potential before first study drug administration) or breast-feeding.

Exclusion Criteria:

* Having taken within the last 2 months or currently taking Vertigoheel®.
* Debilitating acute or chronic illness (i.e. psychiatric illnesses).
* History of sensitivity to any component of the study drug under observation.
* Unwilling or unable to comply with all the requirements of the study protocol.
* Any relationship of dependence with the sponsor or with the investigator.

Primary outcomes:
measure: Dizziness Handicap Inventory
timeFrame: 2 months
Secondary outcomes:
measure: Quality of Life (QoL)
timeFrame: 2 months
measure: Postural Imbalance
timeFrame: 2 months
measure: Depressive Symptoms in Functional Dizziness
timeFrame: 2 months
measure: Anxiety Symptoms in Functional Dizziness
timeFrame: 2 months
Other outcomes:
measure: Vestibular Function in Bilateral Vestibulopathy by Video Head Impulse Test
timeFrame: 2 months
measure: Vestibular Function in Bilateral Vestibulopathy by Caloric Testing
timeFrame: 2 months
Locations:
city: Munich
country: Germany
facility: Department of Neurology, Ludwig Maximilian University
state: Bavaria
Study officials:
affiliation: Department of Neurology, Ludwig-Maximilians-University Munich
name: Michael Strupp, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ganeva D, Tiemann R, Duller S, Strupp M. Improvement of vertigo symptoms after 2 months of Vertigoheel treatment: a case series in patients with bilateral vestibulopathy and functional dizziness. Front Neurol. 2023 Oct 5;14:1264884. doi: 10.3389/fneur.2023.1264884. eCollection 2023.