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

Phase 3

Completed

• Conditions: Cervical Myelopathy
• Interventions: Drug: Placebo; Drug: Limaprost

• Registration Number: NCT02125981
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-24
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-29
• Study Start: 2014-09-01
• Primary Completion: 2022-10-01
• Status Verified: 2023-04
• Study Completion: 2023-04-01
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	taking placebo drug
Limaprost	Limaprost	taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day

Primary Outcome Measures

Name	Time	Method
Japanese Orthopedic Association (JOA) recovery rates	up to 12 months after operation	JOA recovery rate = \[(postoperative JOA score) - (preoperative JOA score)\] / \[(17-(preoperative JOA score)\] x 100 (%).

Secondary Outcome Measures

Name	Time	Method
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)	up to 12 months after operation	The assessment of the efficacy of PET for prediction of drug (Limaprost) effect

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of