Trental for the Treatment of Vertigo/Dizziness/Imbalance

NCT02592863 | Terminated Results

• 1 other identifier: 1214160
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Dizziness; Vertigo

Outcome Measures

Primary Outcomes (3)

• Effect of Trental Treatment Using the Dizziness Handicap Inventory, Vestibular Activities and Participation, and European Evaluation of Vertigo Scale

  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.

  12 weeks

• Effect of Trental Treatment Using 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)

  12 Weeks

• Effect of Trental Treatment Using the 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.

  12 Weeks

Study Arms (2)

Pentoxifylline

EXPERIMENTAL

Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks

Drug: Pentoxifylline

Placebo

PLACEBO COMPARATOR

Patients will take placebo 3 times per day for 12 weeks

Drug: Placebo

Interventions

Pentoxifylline DRUG

Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks

Also known as: Trental

Pentoxifylline

Placebo DRUG

Patients will take placebo 3 times per day for 12 weeks

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 40 years and older
• English as primary language
• 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
• Willingness to complete surveys and take medication as prescribed

You may not qualify if:

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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Dizziness; Vertigo

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Early termination due to placebo effect.

Results Point of Contact

• Title: Assistant Director of Research
• Organization: University of Missouri

schneiderri@health.missouri.edu

573-882-2549

Study Officials

• Arnaldo E Rivera, M.D.

  University of Missouri - Department of Otolaryngology - Head and Neck Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 30, 2015
• Study Start: January 1, 2015
• Primary Completion: December 31, 2020
• Study Completion: April 12, 2021
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-10

Locations

US (1)