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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- The duration of vertigo
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
High dose arm
Have included the Levophencynonate Hydrochloric 1.5mg bid.
Intervention: Levophencynonate Hydrochloric (Drug)
Low dose arm
Have included the Levophencynonate Hydrochloric 1.0mg bid.
Intervention: Levophencynonate Hydrochloric (Drug)
Placebo arm
Have no any active component
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
The duration of vertigo
Time Frame: 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 Outcomes
- Nerve function improved（NIHSS/MRS score）(up to 7 days)
- Vertigo severity improved（VAS score）(up to 7 days)