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

NCT02299804 | Completed Phase 2 DMC

• 1 other identifier: LEVO-PCIV-2001
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertigo

Outcome Measures

Primary Outcomes (1)

• The duration of vertigo

  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.

  up to 7 days

Secondary Outcomes (2)

• Vertigo severity improved（VAS score）

  up to 7 days

• Nerve function improved（NIHSS/MRS score）

  up to 7 days

Study Arms (3)

High dose arm

EXPERIMENTAL

Have included the Levophencynonate Hydrochloric 1.5mg bid.

Drug: Levophencynonate Hydrochloric

Low dose arm

EXPERIMENTAL

Have included the Levophencynonate Hydrochloric 1.0mg bid.

Drug: Levophencynonate Hydrochloric

Placebo arm

PLACEBO COMPARATOR

Have no any active component

Drug: Placebo

Interventions

Levophencynonate Hydrochloric DRUG

this drug is M receptor inhibitor

High dose arm; Low dose arm

Placebo DRUG

No active ingredient

Placebo arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sihuan Pharmaceutical Holdings Group Ltd.: lead

Study Sites (1)

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Vertigo

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yansheng Li, PHD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: November 24, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 15, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)