Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy (REREV)

A Single-center, Prospective, Randomized, Parallel Group, Placebo-controlled Exploratory Study on the Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy

The purpose of this study is to determine whether Renexin is effective in the treatment of vestibular symptoms in patients with recurrent vestibulopathy.

Study Overview

• Status: Terminated
• Conditions: Recurrent Vestibulopathy
• Intervention / Treatment: Drug: Renexin (cilostazol 100mg + gingko biloba extract 80 mg); Drug: Placebo

Detailed Description

1. Study design

   • Among patients who visitied for recurrent vertigo more than 3 months, patients will be included after ruling out other peripheral vertigo through history taking, physical examination, Dix-Hallpike test, head-thrust test.
   • Included patients will go through permission, laboratory tests (CBC, chemical battery, coagulation battery, urine HCG (only women of childbearing age), posturography. During patients selection period for inclusion(2 weeks), taking medication for vertigo is prohibited.
   • Included patients will be randomized to Treatment group (Renexin) and Placebo group.
   • All patients before treatment will do dizziness handicap inventory(DHI), visual analogue scale (VAS) for vertigo, questionnaire for quality of life (SF36).
   • After 4 weeks(+-~ 3 days) of drug administration, DHI, VAS for vertigo, SF36 will be done for drug compliance and side effects.
   • After 8 weeks(+-~ 3 days) of drug administration, posturography, DHI, VAS for vertigo, SF36 will be done for drug compliance and side effects.
   • For control of severe vertigo during drug administration, Valium 2mg can be used as a salvage treatment, and number of valium administration will be checked at every visit.

2. Statistical analysis

   • As a statistical analysis, paired T-test will be used to compare equilibrium score, DHI, VAS, SF-36. When p-value is <0.05, it will be considered as significant difference.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Recurrent vestibulopathy patient with symptoms more than 3 months of recurrent vertigo
• Visual analogue scale (VAS) score between 4 to 8

Exclusion Criteria:

• Showing signs of central lesion in MRI or neurologic exams
• central nystagmus or loss of consciousness with vertigo
• cerebellar symptoms such as ataxia, dysarthria, gait disturbance
• Diagnosed as peripheral vertigo such as benign paroxysmal positional vertigo, Meniere's disease, migrainous vertigo in recent 3 months
• Bilateral vestibular dysfunction
• Vestibular neuronitis symptom appeared in recent 6 months
• Chronic liver disease (ALT>100 or AST>100) or chronic kidney disease (Creatinine > 3.0 mg)
• Blood Hemoglobin < 10mg/dl (in male) or < 8 mg/dl (in female)
• Contraindication for testing drug (ex. Pregnancy or breast feeding etc.)
• Taking antiepileptics such as phenobarbital, phenytoin, carbamazepine or rifampin in recent 2 weeks
• Taking cilostazol, gingko biloba for other disease
• Allergy/hypersensitivity to Renexin
• Severe drug toxicity when taking Renexin previously

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Renexin; Renexin 1T bid for 12 weeks	Drug: Renexin (cilostazol 100mg + gingko biloba extract 80 mg); Take Renexin 1T bid po medication for 8 weeks; Other Names: Renexin
Placebo Comparator: Placebo; Placebo 1T bid for 12 weeks	Drug: Placebo; Take placebo drug 1T bid po medication for 8 weeks; Other Names: Renexin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
equilibrium score of dynamic posturography	compared with pretreatment equilibrium score	after 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dizziness handicap inventory	compared with pretreatment DHI score	at 4 weeks, 8 weeks after treatment
visual analogue scale (VAS) of vertigo	compared with pretreatment VAS score	at 4 weeks, 8 weeks after treatment
Questionnaire for Quality of life (SF36)	compared with pretreatment SF36 score	at 4 weeks, 8 weeks after treatment

Collaborators and Investigators

• Sponsor: Jong Woo Chung
• Collaborators: Asan Medical Center; SK Chemicals Co., Ltd.
• Investigators: Study Chair: Jong Woo Chung, MD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 5, 2013
• First Submitted That Met QC Criteria: July 5, 2013
• First Posted (Estimate): July 10, 2013

Study Record Updates

• Last Update Posted (Estimate): February 17, 2016
• Last Update Submitted That Met QC Criteria: February 14, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Renexin for Recurrent Vestibulopathy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Disease Attributes; Otorhinolaryngologic Diseases; Ear Diseases; Cranial Nerve Diseases; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Recurrence; Vestibular Neuronitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Neuroprotective Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Cilostazol
• Other Study ID Numbers: AMC-2013-0165; 20130055275 (Other Identifier: KFDA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: This study is decided to be terminated. Among 26 participants, 15 finished medication according to the protocol. I am not sure that these data can be analyzed because data is still unblinded.