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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QoL) | Change from baseline in quality of life (QoL) assessed by EQ-5D-5L after 2±1 months Vertigoheel® treatment. The EQ-5D index was used as described by Ludwig et al. (PharmacoEconomics, 2018, 36:663-74), ranging from -0.661 to 1.000, with higher scores indicating better quality of life. QoL was assessed at two time points: baseline and 2 months. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (vHIT) after 2 ± 1 months Vertigoheel ® treatment. The vHIT was performed as described by MacDougall et al. (Neurology, 2009, 73(14):1134-41) to evaluate the function of the vestibulo-ocular reflex (VOR) in the high frequency range for the horizontal semicircular canals. Based on previous HIT data from healthy, asymptomatic subjects, a normal VOR velocity gain was defined as 0.68 or greater (MacDougall et al.2009). Vestibular function was assessed at two time points: baseline and 2 months. Reported values indicate the deviation from baseline values. The 2-month values were examined for significant differences from baseline values. One-sample t-Tests were used to compare mean change from baseline values versus zero (no change). |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Strupp, Prof, MD | Department of Neurology, Ludwig-Maximilians-University Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Ludwig Maximilian University | Munich | Bavaria | 81377 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37869139 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Functional Dizziness | Patients diagnosed with functional dizziness according to the current diagnostic criteria of the Bárány Society. |
| FG001 | Bilateral Vestibulopathy | Patients diagnosed with bilateral vestibulopathy according to the current diagnostic criteria of the Bárány Society. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Functional Dizziness | Patients diagnosed with functional dizziness according to the current diagnostic criteria of the Bárány Society. |
| BG001 | Bilateral Vestibulopathy | Patients diagnosed with bilateral vestibulopathy according to the current diagnostic criteria of the Bárány Society. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 2 months |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Functional Dizziness | Patients diagnosed with functional dizziness according to the current diagnostic criteria of the Bárány Society. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Backache | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Michael Strupp | Hospital of Ludwig Maximilians University, Munich | +49 894400 | 76980 | Michael.Strupp@med.uni-muenchen.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 15, 2021 | Jan 19, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 7, 2022 | Jan 19, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014717 | Vertigo |
| D000071699 | Bilateral Vestibulopathy |
| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Postural Imbalance | Change from baseline in body sway assessed by static posturography after 2±1 months Vertigoheel® treatment. Posturography was assessed as described by Brandt et al. (J Neurol 2012, 259:182-4) with an artificial neural network analysis. Category three of the method for "peripheral vestibular deficit" was evaluated for patients with bilateral vestibulopathy, and category five for "phobic postural vertigo" was evaluated for patients with functional dizziness. Posturography was assessed at two time points: baseline and 2 months. Reported values indicate the deviation from baseline values. Positive values indicate more swaying and negative values indicate less swaying. The higher the value, the more swaying (worse regulation of stand). The 2-month values were examined for significant differences from baseline values. One-sample t-Tests were used to compare mean change from baseline values versus zero (no change). | 2 months |
| 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, ranging from 0 to 27 with higher scores indicating greater severity, was assessed at two time points: baseline and 2 months. | 2 months |
| 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, ranging from 0 to 21 with higher scores indicating greater severity, was assessed at two time points: baseline and 2 months. | 2 months |
| 2 months |
| 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 of Vertigoheel® treatment. Caloric testing was performed as described by Strupp et al. (J Vestib Res. 2017;27(4):177-89) to evaluate the function of the vestibulo-ocular reflex (VOR) in the low-frequency range of the horizontal semicircular canal on each side. Bilaterally reduced angular VOR function is a diagnostic criterion for bilateral vestibulopathy (BVP). Reduced caloric response, i.e., a sum of both responses per ear <6◦/sec, can be considered a safe criterion for BVP. Vestibular function was assessed at two time points: baseline and 2 months. Reported values indicate the deviation from baseline values. The 2-month values were examined for significant differences from baseline values. One-sample t-Tests were used to compare mean change from baseline values versus zero (no change). | 2 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Quality of Life (QoL) | Change from baseline in quality of life (QoL) assessed by EQ-5D-5L after 2±1 months Vertigoheel® treatment. The EQ-5D index was used as described by Ludwig et al. (PharmacoEconomics, 2018, 36:663-74), ranging from -0.661 to 1.000, with higher scores indicating better quality of life. QoL was assessed at two time points: baseline and 2 months. | The QoL data were available for 31 patients with functional dizziness and 11 patients with bilateral vestibulopathy | Posted | Mean | 95% Confidence Interval | units on a scale | 2 months |
|
|
|
| Secondary | Postural Imbalance | Change from baseline in body sway assessed by static posturography after 2±1 months Vertigoheel® treatment. Posturography was assessed as described by Brandt et al. (J Neurol 2012, 259:182-4) with an artificial neural network analysis. Category three of the method for "peripheral vestibular deficit" was evaluated for patients with bilateral vestibulopathy, and category five for "phobic postural vertigo" was evaluated for patients with functional dizziness. Posturography was assessed at two time points: baseline and 2 months. Reported values indicate the deviation from baseline values. Positive values indicate more swaying and negative values indicate less swaying. The higher the value, the more swaying (worse regulation of stand). The 2-month values were examined for significant differences from baseline values. One-sample t-Tests were used to compare mean change from baseline values versus zero (no change). | The postural imbalance data were available for 28 patients with functional dizziness and 13 patients with bilateral vestibulopathy | Posted | Mean | 95% Confidence Interval | arbitrary units | 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, ranging from 0 to 27 with higher scores indicating greater severity, was assessed at two time points: baseline and 2 months. | Posted | Mean | 95% Confidence Interval | score on a scale | 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, ranging from 0 to 21 with higher scores indicating greater severity, was assessed at two time points: baseline and 2 months. | Data from 38 patients were available for this readout. | Posted | Mean | 95% Confidence Interval | score on a scale | 2 months |
|
|
|
| Other Pre-specified | 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 (vHIT) after 2 ± 1 months Vertigoheel ® treatment. The vHIT was performed as described by MacDougall et al. (Neurology, 2009, 73(14):1134-41) to evaluate the function of the vestibulo-ocular reflex (VOR) in the high frequency range for the horizontal semicircular canals. Based on previous HIT data from healthy, asymptomatic subjects, a normal VOR velocity gain was defined as 0.68 or greater (MacDougall et al.2009). Vestibular function was assessed at two time points: baseline and 2 months. Reported values indicate the deviation from baseline values. The 2-month values were examined for significant differences from baseline values. One-sample t-Tests were used to compare mean change from baseline values versus zero (no change). | Data from 12 patients were available for this readout. | Posted | Mean | 95% Confidence Interval | arbitrary units | 2 months |
|
|
|
| Other Pre-specified | 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 of Vertigoheel® treatment. Caloric testing was performed as described by Strupp et al. (J Vestib Res. 2017;27(4):177-89) to evaluate the function of the vestibulo-ocular reflex (VOR) in the low-frequency range of the horizontal semicircular canal on each side. Bilaterally reduced angular VOR function is a diagnostic criterion for bilateral vestibulopathy (BVP). Reduced caloric response, i.e., a sum of both responses per ear <6◦/sec, can be considered a safe criterion for BVP. Vestibular function was assessed at two time points: baseline and 2 months. Reported values indicate the deviation from baseline values. The 2-month values were examined for significant differences from baseline values. One-sample t-Tests were used to compare mean change from baseline values versus zero (no change). | Data from 11 patients were available for this readout. | Posted | Mean | 95% Confidence Interval | arbitrary units | 2 months |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 7 |
| 41 |
| EG001 | Bilateral Vestibulopathy | Patients diagnosed with bilateral vestibulopathy according to the current diagnostic criteria of the Bárány Society. | 0 | 21 | 0 | 21 | 7 | 21 |
| Central retinal artery thrombosis | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Coronavirus disease (COVID-19) | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Fall | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Feeling abnormal | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Injury to toe | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Neoplasia of prostate | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Syncope | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Weakness of lower extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |