Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy

Recurrent Vestibulopathy Clinical Trial

— REREV  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01895400
• Other study ID #: AMC-2013-0165
• Secondary ID: 20130055275
• Status: Terminated
• Phase: Phase 3
• First received: July 5, 2013
• Last updated: February 14, 2016
• Start date: July 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Recurrent Vestibulopathy
• Vestibular Neuronitis

Intervention

Drug:
• Renexin (cilostazol 100mg + gingko biloba extract 80 mg)
Take Renexin 1T bid po medication for 8 weeks
• Placebo
Take placebo drug 1T bid po medication for 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Jong Woo Chung	Asan Medical Center, SK Chemicals Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	equilibrium score of dynamic posturography	compared with pretreatment equilibrium score	after 8 weeks of treatment	No
Secondary	dizziness handicap inventory	compared with pretreatment DHI score	at 4 weeks, 8 weeks after treatment	No
Secondary	visual analogue scale (VAS) of vertigo	compared with pretreatment VAS score	at 4 weeks, 8 weeks after treatment	No
Secondary	Questionnaire for Quality of life (SF36)	compared with pretreatment SF36 score	at 4 weeks, 8 weeks after treatment	Yes