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

Phase 2

Completed

• Conditions: Vertigo
• Interventions: Drug: Levophencynonate Hydrochloric; Drug: Placebo

• Registration Number: NCT02299804
• Lead Sponsor: Sihuan Pharmaceutical Holdings Group Ltd.

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Primary Completion: 2015-05
• Study Completion: 2015-08
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-14
• Last Update Posted: 2016-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

1. At the age more than 18 years old male or female;
2. Patients with vertigo caused by Posterior Circulation Infarction.
3. Patients diagnosed Posterior Circulation Infarction based on the criteria of Posterior Circulation Ischemia of America;
4. Meet the diagnose criteria of vertigo: Visual Motion (External Vertigo), or Rotation, Swing, Lift and Tilt Sensation (Internal Vertigo);
5. Ability to sign the statements of informed consent;

Exclusion Criteria

1. Female patients having Pregnant, Lactating or Birth plan recently;
2. Non-posterior circulation infarction patients;
3. Vertigo caused by any other diseases;
4. Long-term alcohol abuse, or drug abuse;
5. Been in critical condition, difficult to make a precise evaluation of efficacy and safety of new drugs;
6. History of allergies on Levophencynonate Hydrochloric or these compositions;
7. Participation in another clinical trial in three months;
8. Investigator thought that should be excluded due to other reason;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose arm	Levophencynonate Hydrochloric	Have included the Levophencynonate Hydrochloric 1.5mg bid.
Low dose arm	Levophencynonate Hydrochloric	Have included the Levophencynonate Hydrochloric 1.0mg bid.
Placebo arm	Placebo	Have no any active component

Primary Outcome Measures

Name	Time	Method
The duration of vertigo	up to 7 days	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.

Secondary Outcome Measures

Name	Time	Method
Nerve function improved（NIHSS/MRS score）	up to 7 days	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.
Vertigo severity improved（VAS score）	up to 7 days	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.

Trial Locations

Locations (1)

Renji Hospital Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China