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

Study Overview
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Brief Summary
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The limaprost alfadex can improve the surgical outcomes in patients with cervical myelopathy.

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

Conditions
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Cervical Myelopathy

Intervention / Treatment
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* Drug: Limaprost
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Japanese Orthopedic Association (JOA) recovery rates | 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 |  | up to 12 months after operation | 
| Neck disability index score |  | up to 12 months after operation | 
| Japanese orthopaedic association Cervical Myelopathy Evaluation Questionnaire score |  | up to 12 months after operation | 
| Questionnaire Short Form 12 |  | up to 12 months after operation | 
| Japanese orthopaedic association score |  | up to 12 months after surgery | 
| assessment of the efficacy of positron emission tomography (PET) | The assessment of the efficacy of PET for prediction of drug (Limaprost) effect | up to 12 months after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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limaprost alfadex, cervical myelopathy, surgery