Clinical trial NCT01895400: Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy
Official title: A Single-center, Prospective, Randomized, Parallel Group, Placebo-controlled Exploratory Study on the Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Recurrent Vestibulopathy
Keywords: Renexin for Recurrent Vestibulopathy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: SK Chemicals Co., Ltd.
name: Asan Medical Center
First posted: 2013-07-10
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: equilibrium score of dynamic posturography
timeFrame: after 8 weeks of treatment
Secondary outcomes:
measure: dizziness handicap inventory
timeFrame: at 4 weeks, 8 weeks after treatment
measure: visual analogue scale (VAS) of vertigo
timeFrame: at 4 weeks, 8 weeks after treatment
measure: Questionnaire for Quality of life (SF36)
timeFrame: at 4 weeks, 8 weeks after treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Jong Woo Chung, MD
role: STUDY_CHAIR
References: