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

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

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.

Study Overview

• Status: Completed
• Conditions: Vertigo
• Intervention / Treatment: Drug: Levophencynonate Hydrochloric; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Renji Hospital Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sihuan Pharmaceutical Holdings Group Ltd.
• Investigators: Principal Investigator: Yansheng Li, PHD, RenJi Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: October 9, 2014
• First Submitted That Met QC Criteria: November 20, 2014
• First Posted (Estimate): November 24, 2014

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 14, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Dizziness
• Other Study ID Numbers: LEVO-PCIV-2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No