Trial | NCT02299804  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    levophencynonate ...

  • Study Participants

    98
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.
Study Started
Jan 31
2014
Primary Completion
May 31
2015
Study Completion
Aug 31
2015
Last Update
Apr 15
2016
Estimate

Drug Levophencynonate Hydrochloric

this drug is M receptor inhibitor

Drug Placebo

No active ingredient

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

Criteria 

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;
No Results Posted