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

Cervical Myelopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125981
• Other study ID #: LIMA_001
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2014
• Est. completion date: April 1, 2023

Study information

• Verified date: April 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 1, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Cervical Myelopathy
• Spinal Cord Diseases

Intervention

Drug:
• Limaprost
taking Limaprost a-Cyclodextrin Clathrate 1 Tablets (166.67 µg), three times per day
• Placebo
taking placebo drug

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analog Pain Scale for neck pain		up to 12 months after operation
Secondary	Neck disability index score		up to 12 months after operation
Secondary	Japanese orthopaedic association Cervical Myelopathy Evaluation Questionnaire score		up to 12 months after operation
Secondary	Questionnaire Short Form 12		up to 12 months after operation
Secondary	Japanese orthopaedic association score		up to 12 months after surgery
Secondary	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