A Clinical Trial To Evaluate Efficacy And Safety Of Levophencynonate Hydrochloride In Patient With Vertigo

Study Overview
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Brief Summary
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A Multicenter, Double-Blind, Placebo Controlled, Phase Ⅱa clinical trial to enroll 120 patients with Vertigo Caused By Posterior Circulation Infarction during 7 days, then to evaluate the efficacy of different dose of Levophencynonate Hydrochloric, and provide the effective dosage for phase IIb clinical study, to study the safety of Levophencynonate Hydrochloric.

Detailed Description
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This study will conduct in 15 sites to enrolled 120 patients with vertigo under 7 days treatment and 7 days follow-up. The study includes three arms: high dose, low dose and placebo control.To observe the efficacy by change of vertigo severity and duration,and safety by vital sign,adverse event,etc.

Official Title
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A Multicenter, Double-Blind, Phase Ⅱ Clinical Trial To Evaluate Efficacy And Safety Of Levophencynonate Hydrochloride In Patient With Vertigo Caused By Posterior Circulation Infarction

Conditions
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Vertigo

Intervention / Treatment
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* Drug: Levophencynonate Hydrochloric
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At the age more than 18 years old male or female; Patients with vertigo caused by Posterior Circulation Infarction. Patients diagnosed Posterior Circulation Infarction based on the criteria of Posterior Circulation Ischemia of America; Meet the diagnose criteria of vertigo: Visual Motion (External Vertigo), or Rotation, Swing, Lift and Tilt Sensation (Internal Vertigo); Ability to sign the statements of informed consent; Exclusion Criteria: Female patients having Pregnant, Lactating or Birth plan recently; Non-posterior circulation infarction patients; Vertigo caused by any other diseases; Long-term alcohol abuse, or drug abuse; Been in critical condition, difficult to make a precise evaluation of efficacy and safety of new drugs; History of allergies on Levophencynonate Hydrochloric or these compositions; Participation in another clinical trial in three months; Investigator thought that should be excluded due to other reason;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose arm<br>Have included the Levophencynonate Hydrochloric 1.5mg bid. | Drug: Levophencynonate Hydrochloric<br>* this drug is M receptor inhibitor<br>|
| Experimental: Low dose arm<br>Have included the Levophencynonate Hydrochloric 1.0mg bid. | Drug: Levophencynonate Hydrochloric<br>* this drug is M receptor inhibitor<br>|
| Placebo Comparator: Placebo arm<br>Have no any active component | Drug: Placebo<br>* No active ingredient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of vertigo | The Software Statistical Analysis System (SAS) will be used to deal with 98 subjects' data in the trial. The descriptive statistics will be presented for all efficacy and safety variables. All of questionnaire will be resolved by investigator detailed. Hypothesis test results of effectiveness provide evidence as reference. | up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vertigo severity improved（VAS score） | The Software Statistical Analysis System (SAS) will be used to deal with the 98 patients' data in the trial. The descriptive statistics will be presented for all efficacy and safety variables. All of questionnaires will be resolved by investigator.Hypothesis test results of effectiveness provide evidence as reference. | up to 7 days | 
| Nerve function improved（NIHSS/MRS score） | The Software Statistical Analysis System (SAS) will be used to deal with the 98 patients' data in the trial. The descriptive statistics will be presented for all efficacy and safety variables. All of questionnaires will be resolved by investigator.Hypothesis test results of effectiveness provide evidence as reference. | up to 7 days |