Trial Outcomes & Findings for Impact of Vertigoheel® on Patients Suffering From Bilateral Vestibulopathy and Functional Dizziness (NCT NCT05897853)
NCT ID: NCT05897853
Last Updated: 2025-05-14
Results Overview
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.
COMPLETED
62 participants
2 months
2025-05-14
Participant Flow
Participant milestones
| Measure |
Functional Dizziness
Patients diagnosed with functional dizziness according to the current diagnostic criteria of the Bárány Society.
|
Bilateral Vestibulopathy
Patients diagnosed with bilateral vestibulopathy according to the current diagnostic criteria of the Bárány Society.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
21
|
|
Overall Study
Confirmed Diagnostic Criteria at Baseline
|
41
|
13
|
|
Overall Study
COMPLETED
|
39
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
8
|
Reasons for withdrawal
| Measure |
Functional Dizziness
Patients diagnosed with functional dizziness according to the current diagnostic criteria of the Bárány Society.
|
Bilateral Vestibulopathy
Patients diagnosed with bilateral vestibulopathy according to the current diagnostic criteria of the Bárány Society.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Diagnostic criteria not met at baseline
|
0
|
8
|
Baseline Characteristics
Impact of Vertigoheel® on Patients Suffering From Bilateral Vestibulopathy and Functional Dizziness
Baseline characteristics by cohort
| Measure |
Functional Dizziness
n=41 Participants
Patients diagnosed with functional dizziness according to the current diagnostic criteria of the Bárány Society.
|
Bilateral Vestibulopathy
n=13 Participants
Patients diagnosed with bilateral vestibulopathy according to the current diagnostic criteria of the Bárány Society.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 14.9 • n=93 Participants
|
64.1 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
64.3 years
STANDARD_DEVIATION 14.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
41 participants
n=93 Participants
|
13 participants
n=4 Participants
|
54 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 monthsChange 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.
Outcome measures
| Measure |
Functional Dizziness
n=39 Participants
Patients diagnosed with functional dizziness according to the current diagnostic criteria of the Bárány Society.
|
Bilateral Vestibulopathy
n=13 Participants
Patients diagnosed with bilateral vestibulopathy according to the current diagnostic criteria of the Bárány Society.
|
|---|---|---|
|
Dizziness Handicap Inventory
|
-12.0 score on a scale
Interval -17.8 to -6.2
|
-13.2 score on a scale
Interval -19.5 to -7.0
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: The QoL data were available for 31 patients with functional dizziness and 11 patients with bilateral vestibulopathy
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.
Outcome measures
| Measure |
Functional Dizziness
n=31 Participants
Patients diagnosed with functional dizziness according to the current diagnostic criteria of the Bárány Society.
|
Bilateral Vestibulopathy
n=11 Participants
Patients diagnosed with bilateral vestibulopathy according to the current diagnostic criteria of the Bárány Society.
|
|---|---|---|
|
Quality of Life (QoL)
|
0.121 units on a scale
Interval 0.018 to 0.223
|
0.067 units on a scale
Interval -0.013 to 0.146
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: The postural imbalance data were available for 28 patients with functional dizziness and 13 patients with bilateral vestibulopathy
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).
Outcome measures
| Measure |
Functional Dizziness
n=28 Participants
Patients diagnosed with functional dizziness according to the current diagnostic criteria of the Bárány Society.
|
Bilateral Vestibulopathy
n=13 Participants
Patients diagnosed with bilateral vestibulopathy according to the current diagnostic criteria of the Bárány Society.
|
|---|---|---|
|
Postural Imbalance
|
2.8 arbitrary units
Interval -3.8 to 9.3
|
0.2 arbitrary units
Interval -4.9 to 5.2
|
SECONDARY outcome
Timeframe: 2 monthsChange 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.
Outcome measures
| Measure |
Functional Dizziness
n=39 Participants
Patients diagnosed with functional dizziness according to the current diagnostic criteria of the Bárány Society.
|
Bilateral Vestibulopathy
Patients diagnosed with bilateral vestibulopathy according to the current diagnostic criteria of the Bárány Society.
|
|---|---|---|
|
Depressive Symptoms in Functional Dizziness
|
-2.2 score on a scale
Interval -3.5 to -1.0
|
—
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Data from 38 patients were available for this readout.
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.
Outcome measures
| Measure |
Functional Dizziness
n=38 Participants
Patients diagnosed with functional dizziness according to the current diagnostic criteria of the Bárány Society.
|
Bilateral Vestibulopathy
Patients diagnosed with bilateral vestibulopathy according to the current diagnostic criteria of the Bárány Society.
|
|---|---|---|
|
Anxiety Symptoms in Functional Dizziness
|
-2.0 score on a scale
Interval -3.5 to -0.6
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 monthsPopulation: Data from 12 patients were available for this readout.
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).
Outcome measures
| Measure |
Functional Dizziness
n=12 Participants
Patients diagnosed with functional dizziness according to the current diagnostic criteria of the Bárány Society.
|
Bilateral Vestibulopathy
Patients diagnosed with bilateral vestibulopathy according to the current diagnostic criteria of the Bárány Society.
|
|---|---|---|
|
Vestibular Function in Bilateral Vestibulopathy by Video Head Impulse Test
|
-0.02 arbitrary units
Interval -0.06 to 0.03
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 monthsPopulation: Data from 11 patients were available for this readout.
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).
Outcome measures
| Measure |
Functional Dizziness
n=11 Participants
Patients diagnosed with functional dizziness according to the current diagnostic criteria of the Bárány Society.
|
Bilateral Vestibulopathy
Patients diagnosed with bilateral vestibulopathy according to the current diagnostic criteria of the Bárány Society.
|
|---|---|---|
|
Vestibular Function in Bilateral Vestibulopathy by Caloric Testing
|
5.5 arbitrary units
Interval -4.3 to 15.3
|
—
|
Adverse Events
Functional Dizziness
Bilateral Vestibulopathy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Functional Dizziness
n=41 participants at risk
Patients diagnosed with functional dizziness according to the current diagnostic criteria of the Bárány Society.
|
Bilateral Vestibulopathy
n=21 participants at risk
Patients diagnosed with bilateral vestibulopathy according to the current diagnostic criteria of the Bárány Society.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Backache
|
0.00%
0/41 • 2 months
|
4.8%
1/21 • Number of events 1 • 2 months
|
|
Vascular disorders
Central retinal artery thrombosis
|
2.4%
1/41 • Number of events 1 • 2 months
|
0.00%
0/21 • 2 months
|
|
Infections and infestations
Coronavirus disease (COVID-19)
|
2.4%
1/41 • Number of events 1 • 2 months
|
0.00%
0/21 • 2 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/41 • 2 months
|
14.3%
3/21 • Number of events 3 • 2 months
|
|
Musculoskeletal and connective tissue disorders
Fall
|
2.4%
1/41 • Number of events 1 • 2 months
|
4.8%
1/21 • Number of events 1 • 2 months
|
|
Nervous system disorders
Feeling abnormal
|
2.4%
1/41 • Number of events 1 • 2 months
|
4.8%
1/21 • Number of events 1 • 2 months
|
|
Musculoskeletal and connective tissue disorders
Injury to toe
|
2.4%
1/41 • Number of events 1 • 2 months
|
0.00%
0/21 • 2 months
|
|
Renal and urinary disorders
Neoplasia of prostate
|
0.00%
0/41 • 2 months
|
4.8%
1/21 • Number of events 1 • 2 months
|
|
Vascular disorders
Syncope
|
2.4%
1/41 • Number of events 1 • 2 months
|
0.00%
0/21 • 2 months
|
|
Musculoskeletal and connective tissue disorders
Weakness of lower extremity
|
2.4%
1/41 • Number of events 1 • 2 months
|
0.00%
0/21 • 2 months
|
Additional Information
Prof. Dr. Michael Strupp
Hospital of Ludwig Maximilians University, Munich
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place