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

Jong Woo Chung

Status and phase: Terminated; Phase 3

Conditions: Recurrent Vestibulopathy

Treatments: Drug: Placebo; Drug: Renexin (cilostazol 100mg + gingko biloba extract 80 mg)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01895400

AMC-2013-0165

20130055275 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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26 participants in 2 patient groups, including a placebo group

Renexin

Active Comparator group

Description:

Renexin 1T bid for 12 weeks

Treatment:

Drug: Renexin (cilostazol 100mg + gingko biloba extract 80 mg)

Placebo

Placebo Comparator group

Description:

Placebo 1T bid for 12 weeks

Treatment:

Drug: Placebo