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