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

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sihuan Pharmaceutical Holdings Group Ltd.

Criteria

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;