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

NCT05897853 | Completed Results

• 1 other identifier: 7564
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertigo; Functional Dizziness; Bilateral Vestibulopathy

Keywords

real world evidence; non-interventional study; patient reported outcome

Outcome Measures

Primary Outcomes (1)

• Dizziness Handicap Inventory

  Change from baseline in dizziness handicap inventory (DHI) after 2±1 months Vertigoheel® treatment. The DHI, ranging from 0 to 100 with higher scores indicating greater severity, was assessed at two time points: baseline and 2 months.

  2 months

Secondary Outcomes (4)

• Quality of Life (QoL)

  2 months

• Postural Imbalance

  2 months

• Depressive Symptoms in Functional Dizziness

  2 months

• Anxiety Symptoms in Functional Dizziness

  2 months

Other Outcomes (2)

• Vestibular Function in Bilateral Vestibulopathy by Video Head Impulse Test

  2 months

• Vestibular Function in Bilateral Vestibulopathy by Caloric Testing

  2 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Department of Neurology, Ludwig Maximilian University

Munich, Bavaria, 81377, Germany

Location

Related Publications (1)

• 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.

  PMID: 37869139 RESULT

MeSH Terms

Conditions

Vertigo; Bilateral Vestibulopathy

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Prof. Dr. Michael Strupp
• Organization: Hospital of Ludwig Maximilians University, Munich

Michael.Strupp@med.uni-muenchen.de

+49 894400

Study Officials

• Michael Strupp, Prof, MD

  Department of Neurology, Ludwig-Maximilians-University Munich

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 9, 2023
• Study Start: November 29, 2021
• Primary Completion: December 5, 2022
• Study Completion: December 5, 2022
• Last Updated: May 14, 2025
• Results First Posted: May 14, 2025

Record last verified: 2025-04

Locations

DE (1)