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Trental for the Treatment of Vertigo/Dizziness/Imbalance

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ClinicalTrials.gov Identifier: NCT02592863
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Arnaldo L. Rivera, University of Missouri-Columbia

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.


Condition or disease Intervention/treatment Phase
Dizziness Vertigo Drug: Pentoxifylline Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Randomized Trial of Pentoxifylline for Imbalance Secondary to Insufficient Microvascular Perfusion
Study Start Date : January 2015
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : April 12, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pentoxifylline
Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks
Drug: Pentoxifylline
Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks
Other Name: Trental

Placebo Comparator: Placebo
Patients will take placebo 3 times per day for 12 weeks
Drug: Placebo
Patients will take placebo 3 times per day for 12 weeks




Primary Outcome Measures :
  1. Effect of Trental as assessed by Quality of Life questionnaire [ Time Frame: 2-3 years ]
    Validated questionnaire that will assess the patients quality of life, symptom severity, and functionality as reported by the patient



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592863


Locations
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United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Arnaldo E Rivera, M.D. University of Missouri - Department of Otolaryngology - Head and Neck Surgery
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Responsible Party: Arnaldo L. Rivera, Associate Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02592863    
Other Study ID Numbers: 1214160
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Sensation Disorders
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants