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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
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
April 24, 2014
Last Updated
April 12, 2023
Sponsor
Seoul National University Hospital
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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
No

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
No
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

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

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