Impact of Vertigoheel® on Patients Suffering From Bilateral Vestibulopathy and Functional Dizziness

Vertigo Clinical Trial

— HealVertigo  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05897853
• Other study ID #: 7564
• Status: Completed
• Start date: November 29, 2021
• Est. completion date: December 5, 2022

Study information

• Verified date: June 2023
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 5, 2022
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bilateral Vestibulopathy
• Dizziness
• Vertigo

Locations

Country	Name	City	State
Germany	Department of Neurology, Ludwig Maximilian University	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vestibular function in bilateral vestibulopathy by video head impulse test	Change from baseline in vestibular function of bilateral vestibulopathy patients assessed by video head impulse test after 2±1 months Vertigoheel® treatment.	2 months
Other	Vestibular function in bilateral vestibulopathy by caloric testing	Change from baseline in vestibular function of bilateral vestibulopathy patients assessed by caloric testing after 2±1 months Vertigoheel® treatment.	2 months
Primary	Dizziness handicap inventory	Change from baseline in dizziness handicap inventory (DHI) after 2±1 months Vertigoheel® treatment. The DHI has a range from 0 to 100, the higher the score the worse.	2 months
Secondary	Quality of life (QoL)	Change from baseline in quality of life (QoL) assessed by EQ-5D-5L after 2±1 months Vertigoheel® treatment	2 months
Secondary	Postural imbalance	Change from baseline in body sway assessed by static posturography after 2±1 months Vertigoheel® treatment	2 months
Secondary	Depressive symptoms in functional dizziness	Change from baseline in depressive symptoms of functional dizziness patients assessed by PHQ-9 questionnaires after 2±1 months Vertigoheel® treatment. The PHQ-9 has a range from 0 to 27, the higher the score the worse.	2 months
Secondary	Anxiety symptoms in functional dizziness	Change from baseline in anxiety symptoms of functional dizziness patients assessed by GAD-7 questionnaires after 2±1 months Vertigoheel® treatment. The GAD-7 has a range from 0 to 21, the higher the score the worse.	2 months