Trial Outcomes & Findings for Trental for the Treatment of Vertigo/Dizziness/Imbalance (NCT NCT02592863)

Last Updated: 2024-10-15

Results Overview

The Dizziness Handicap Inventory (DHI) is 25 question self report questionnaire that measures how dizziness affects a person's daily life. The questions are grouped into three domains: physical (P), emotional (E), and functional (F). Each question has three possible answers: "Always", "Sometimes", or "No". The answers are worth points, with "Always" being worth 4 points, "Sometimes" worth 2 points, and "No" worth 0 points. After answering all the questions, the total score is calculated, ranging from 0 to 100 points. A higher score indicates a more severe handicap, with 0 points indicating no effect and 100 points indicating maximum effect.

Recruitment status

TERMINATED

Study phase

Target enrollment

26 participants

Primary outcome timeframe

12 weeks

Results posted on

2024-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	Pentoxifylline Pentoxifylline: Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks	Placebo Placebo: Patients will take placebo 3 times per day for 12 weeks
Overall Study STARTED	10	16
Overall Study COMPLETED	7	13
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Pentoxifylline Pentoxifylline: Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks	Placebo Placebo: Patients will take placebo 3 times per day for 12 weeks
Overall Study Withdrawal by Subject	2	2
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Trental for the Treatment of Vertigo/Dizziness/Imbalance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pentoxifylline n=7 Participants Pentoxifylline: Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks	Placebo n=13 Participants Placebo: Patients will take placebo 3 times per day for 12 weeks	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	13 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Determine the effect of 12 weeks of Trental compared to Placebo in patients with reported dizziness on the Dizziness Handicap Inventory

Outcome measures

Outcome measures
Measure	Pentoxifylline n=7 Participants Pentoxifylline: Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks	Placebo n=13 Participants Placebo: Patients will take placebo 3 times per day for 12 weeks
Effect of Trental Treatment Using the Dizziness Handicap Inventory, Vestibular Activities and Participation, and European Evaluation of Vertigo Scale Baseline DHI	46.57 Score on a scale Standard Deviation 16.236	53.85 Score on a scale Standard Deviation 22.825
Effect of Trental Treatment Using the Dizziness Handicap Inventory, Vestibular Activities and Participation, and European Evaluation of Vertigo Scale End of Treatment DHI	36.57 Score on a scale Standard Deviation 20.582	42.83 Score on a scale Standard Deviation 22.262

PRIMARY outcome

Timeframe: 12 Weeks

Population: Determine the effect of 12 weeks of Trental compared to Placebo in patients with reported dizziness on the European Evaluation of Vertigo scale

The European Evaluation of Vertigo scale (EEV) is a physician-administered questionnaire that only assesses symptoms of the vestibular syndrome: illusion of movement, duration of illusion, motion intolerance, neurovegetative signs, and instability. The symptoms are ranked on a scale of 0 (no problem) to 4 (severe problem) and each area of assessment is stand alone (meaning the scores from each area to do not combine to create one larger score)

Outcome measures

Outcome measures
Measure	Pentoxifylline n=7 Participants Pentoxifylline: Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks	Placebo n=13 Participants Placebo: Patients will take placebo 3 times per day for 12 weeks
Effect of Trental Treatment Using the European Evaluation of Vertigo Scale Baseline EEV - Illusion of Movement	2.00 units on a scale Standard Deviation 1.155	2.62 units on a scale Standard Deviation 0.768
Effect of Trental Treatment Using the European Evaluation of Vertigo Scale End of Treatment EEV - Motion Intolerance	0.57 units on a scale Standard Deviation 1.134	0.55 units on a scale Standard Deviation 0.934
Effect of Trental Treatment Using the European Evaluation of Vertigo Scale Baseline EEV - Neurovegetative	0.14 units on a scale Standard Deviation 0.378	0.92 units on a scale Standard Deviation 1.256
Effect of Trental Treatment Using the European Evaluation of Vertigo Scale End of Treatment (EOT) - Illusion of movement	1.57 units on a scale Standard Deviation 1.272	1.55 units on a scale Standard Deviation 1.128
Effect of Trental Treatment Using the European Evaluation of Vertigo Scale Baseline EEV - Duration of Illusion	2.00 units on a scale Standard Deviation 1.291	2.46 units on a scale Standard Deviation 1.127
Effect of Trental Treatment Using the European Evaluation of Vertigo Scale EOT EEV - Duration of Illusion	1.43 units on a scale Standard Deviation 0.787	1.64 units on a scale Standard Deviation 1.206
Effect of Trental Treatment Using the European Evaluation of Vertigo Scale Baseline EEV - Motion Intolerance	0.86 units on a scale Standard Deviation 1.464	0.69 units on a scale Standard Deviation 0.947
Effect of Trental Treatment Using the European Evaluation of Vertigo Scale End of Treatment EEV - Neurovegetative	0 units on a scale Standard Deviation 0	0.45 units on a scale Standard Deviation 1.036
Effect of Trental Treatment Using the European Evaluation of Vertigo Scale Baseline EEV - Instability	2.29 units on a scale Standard Deviation 0.756	2.46 units on a scale Standard Deviation 0.776
Effect of Trental Treatment Using the European Evaluation of Vertigo Scale EOT - Instability	1.0 units on a scale Standard Deviation 0.816	1.145 units on a scale Standard Deviation 0.820

PRIMARY outcome

Timeframe: 12 Weeks

Population: Determine the effect of 12 weeks of Trental compared to Placebo in patients with reported dizziness on Vestibular Activities and participation survey

Vestibular Activities and Participation (VAP) is 34-item self-report tool that measures the extent of activity limitations and participation restrictions caused by vestibular disorders. The VAP can be used for assessment, intervention planning, outcome evaluation, and to reflect a patient's status. Answers are ranked on a likert scale where 0 is no problem and 4 is unable to do. Scores are averaged and the higher the score the worse the problem, such that 0 is no problem and 54 or great is a severe problem.

Outcome measures

Outcome measures
Measure	Pentoxifylline n=7 Participants Pentoxifylline: Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks	Placebo n=13 Participants Placebo: Patients will take placebo 3 times per day for 12 weeks
Effect of Trental Treatment Using the Vestibular Activities and Participation Survey Baseline VAP	1.487 score on a scale Standard Deviation 0.5914	1.405 score on a scale Standard Deviation 0.5894
Effect of Trental Treatment Using the Vestibular Activities and Participation Survey End of treatment VAP	1.12 score on a scale Standard Deviation 0.642	1.02 score on a scale Standard Deviation 0.809

Adverse Events

Pentoxifylline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Assistant Director of Research

University of Missouri

Phone: 573-882-2549

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place