Clinical trial NCT02592863: Trental for the Treatment of Vertigo/Dizziness/Imbalance
Official title: A Double-Blind, Placebo-Controlled, Randomized Trial of Pentoxifylline for Imbalance Secondary to Insufficient Microvascular Perfusion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dizziness
Vertigo
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2015-10-30
Enrollment: 26
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Imbalance, dizziness and vertigo as a result of problems in the inner ear (vestibular dysfunction) are becoming increasingly more prevalent in Americans 40 years of age and older. The symptoms have a severe impact on affected individuals with detrimental effects on work, travel, social and family life. These patients see doctors often with no relief in their symptoms.

The most promising help for these patients is to use medication that will increase blood flow to the inner ear. Pentoxifylline (Trental) has been shown to increase microvascular blood flow.

Detailed description: One potential cause of vestibular dysfunction is a decrease in or insufficient blood flow to the inner ear. Studies have shown that when the blood flow is decreased to the inner ear, patients will become dizzy and off balance. This study will use validated instruments to evaluate the effectiveness of Trental in patients that present to our providers with vertigo, dizziness, or imbalance and meet inclusion criteria. They will be blinded and randomized to treatment or placebo, which they will take for \~12 weeks. Patients will completed validated surveys 3 times (beginning, middle and end of study) as well as account for the number of times they have fallen and if they have missed any work due to their symptoms.

Eligibility criteria: Inclusion Criteria:

1. Adults 40 years and older
2. English as primary language
3. Diagnosis of multisensory losses, presbystasis, bilateral vestibulopathy, central vascular insufficiency, small vessel circulatory disease, generalized imbalance, and idiopathic peripheral vertigo scoring at least 16 on the Dizziness Handicap Inventory
4. Willingness to complete surveys and take medication as prescribed

Exclusion Criteria:

1. Diagnosis of the following: benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine with headache, intracranial mass, perilymphatic fistula, or multiple sclerosis
2. history of cholesteatoma
3. Prior ear surgery other than myringotomy and tube placement
4. Prior radiation to head or neck
5. previous use of vestibulotoxic medications where the enrolling provider determines the drug exposure to be the cause of imbalance
6. Use of blood thinning medications
7. intolerance/allergy to pentoxifylline or methylxanthines, as well as recent cerebral or retinal hemorrhage (past 3 months)
8. Pregnant or lactating females.

Primary outcomes:
measure: Effect of Trental Treatment Using the Dizziness Handicap Inventory, Vestibular Activities and Participation, and European Evaluation of Vertigo Scale
timeFrame: 12 weeks
measure: Effect of Trental Treatment Using the European Evaluation of Vertigo Scale
timeFrame: 12 Weeks
measure: Effect of Trental Treatment Using the Vestibular Activities and Participation Survey
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri - Department of Otolaryngology - Head and Neck Surgery
name: Arnaldo E Rivera, M.D.
role: PRINCIPAL_INVESTIGATOR
References: