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NCT Number: NCT02299804

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Levophencynonate Hydrochloric

Drug

this drug is M receptor inhibitor

Placebo

Drug

No active ingredient

Primary outcomes

  1. 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

  1. Vertigo severity improved(VAS score)

    Time frame: 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.

  2. Nerve function improved(NIHSS/MRS score)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sihuan Pharmaceutical Holdings Group Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 24, 2014
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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