Recurrent Vestibulopathy Clinical Trial
— REREVOfficial title:
A Single-center, Prospective, Randomized, Parallel Group, Placebo-controlled Exploratory Study on the Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy
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 |
The purpose of this study is to determine whether Renexin is effective in the treatment of vestibular symptoms in patients with recurrent vestibulopathy.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Jong Woo Chung | Asan Medical Center, SK Chemicals Co.,Ltd. |
Korea, Republic of,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
NCT04026516 -
CAVA: Dizziness Trial
|
N/A |