The Study About the Efficacy of Oral Limaprost After Surgery for Cervical Myelopathy

April 12, 2023 updated by: Jin S. Yeom, Seoul National University Hospital

A Prospective Randomized Double-blinded Clinical Trial About the Efficacy of Oral Limaprost Administration Following Surgery for Cervical Myelopathy

The limaprost alfadex can improve the surgical outcomes in patients with cervical myelopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Older than 20 years old
  • Compressive cervical myelopathy, confirmed by MRI, including C1-C2 instability, ossification of posterior longitudinal ligament
  • Plan to undergo cervical surgery for myelopathy
  • JOA score less than 15 points
  • Signed informed consent of patient or legal guardian

Exclusion Criteria:

  • Infection or malignancy
  • Taking Limaprost before surgery
  • Pregnancy or expected to be pregnant or breast feeding
  • severe cardiovascular, pulmonary, renal disease or distress, brain pathology
  • any related coagulopathy
  • any drug to cause bleeding tendency
  • severe pain from other disease
  • any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study
  • patient cannot follow study protocol, for any reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Limaprost
taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day
Drug: Limaprost
taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day
Placebo Comparator: Control
taking placebo drug
Drug: Placebo
taking placebo drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Japanese Orthopedic Association (JOA) recovery rates
Time Frame: up to 12 months after operation
JOA recovery rate = [(postoperative JOA score) - (preoperative JOA score)] / [(17-(preoperative JOA score)] x 100 (%).
up to 12 months after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Pain Scale for neck pain
Time Frame: up to 12 months after operation
up to 12 months after operation
Neck disability index score
Time Frame: up to 12 months after operation
up to 12 months after operation
Japanese orthopaedic association Cervical Myelopathy Evaluation Questionnaire score
Time Frame: up to 12 months after operation
up to 12 months after operation
Questionnaire Short Form 12
Time Frame: up to 12 months after operation
up to 12 months after operation
Japanese orthopaedic association score
Time Frame: up to 12 months after surgery
up to 12 months after surgery
assessment of the efficacy of positron emission tomography (PET)
Time Frame: up to 12 months after operation
The assessment of the efficacy of PET for prediction of drug (Limaprost) effect
up to 12 months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jin S. Yeom, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimate)

April 29, 2014

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIMA_001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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