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

Primary Purpose

Cervical Myelopathy

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Limaprost

Placebo

About this trial

This is an interventional treatment trial for Cervical Myelopathy focused on measuring limaprost alfadex, cervical myelopathy, surgery

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Limaprost

Control

Arm Description

taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day

taking placebo drug

Outcomes

Primary Outcome Measures

Japanese Orthopedic Association (JOA) recovery rates

JOA recovery rate = [(postoperative JOA score) - (preoperative JOA score)] / [(17-(preoperative JOA score)] x 100 (%).

Secondary Outcome Measures

Visual Analog Pain Scale for neck pain

Neck disability index score

Japanese orthopaedic association Cervical Myelopathy Evaluation Questionnaire score

Questionnaire Short Form 12

Japanese orthopaedic association score

assessment of the efficacy of positron emission tomography (PET)

The assessment of the efficacy of PET for prediction of drug (Limaprost) effect

Full Information

NCT ID

NCT02125981

First Posted

April 24, 2014

Last Updated

April 12, 2023

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02125981

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

September 1, 2014 (Actual)

Primary Completion Date

October 1, 2022 (Actual)

Study Completion Date

April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Myelopathy

Keywords

limaprost alfadex, cervical myelopathy, surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Limaprost

Arm Type

Experimental

Arm Description

taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

taking placebo drug

Intervention Type

Drug

Intervention Name(s)

Limaprost

Intervention Description

taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

taking placebo drug

Primary Outcome Measure Information:

Title

Japanese Orthopedic Association (JOA) recovery rates

Description

JOA recovery rate = [(postoperative JOA score) - (preoperative JOA score)] / [(17-(preoperative JOA score)] x 100 (%).

Time Frame

up to 12 months after operation

Secondary Outcome Measure Information:

Title

Visual Analog Pain Scale for neck pain

Time Frame

up to 12 months after operation

Title

Neck disability index score

Time Frame

up to 12 months after operation

Title

Japanese orthopaedic association Cervical Myelopathy Evaluation Questionnaire score

Time Frame

up to 12 months after operation

Title

Questionnaire Short Form 12

Time Frame

up to 12 months after operation

Title

Japanese orthopaedic association score

Time Frame

up to 12 months after surgery

Title

assessment of the efficacy of positron emission tomography (PET)

Description

The assessment of the efficacy of PET for prediction of drug (Limaprost) effect

Time Frame

up to 12 months after operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jin S. Yeom

Organizational Affiliation

Seoul National University Bundang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

463-707

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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