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

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ClinicalTrials.gov Identifier: NCT02299804
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Sihuan Pharmaceutical Holdings Group Ltd.

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.

Condition or disease Intervention/treatment Phase
Vertigo Drug: Levophencynonate Hydrochloric Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02299804


Locations
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China, Shanghai
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
Sihuan Pharmaceutical Holdings Group Ltd.
Investigators
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Principal Investigator: Yansheng Li, PHD RenJi Hospital

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Responsible Party: Sihuan Pharmaceutical Holdings Group Ltd.
ClinicalTrials.gov Identifier: NCT02299804     History of Changes
Other Study ID Numbers: LEVO-PCIV-2001
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders