Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jong Woo Chung
• Collaborators: Asan Medical Center; SK Chemicals Co., Ltd.; SK Chemicals Co.,Ltd.
• Treatments: Cilostazol

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