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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose arm | Experimental | Have included the Levophencynonate Hydrochloric 1.5mg bid. |
|
| Low dose arm | Experimental | Have included the Levophencynonate Hydrochloric 1.0mg bid. |
|
| Placebo arm | Placebo Comparator | Have no any active component |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levophencynonate Hydrochloric | Drug | this drug is M receptor inhibitor |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yansheng Li, PHD | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200127 | China |
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| ID | Term |
|---|---|
| D014717 | Vertigo |
| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Placebo | Drug | No active ingredient |
|
| 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 |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |