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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT02125981

Collaborator

(none)

160

Enrollment

Location

Arms

112

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cervical Myelopathy	Drug: Limaprost Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Limaprost

taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day

Drug: Limaprost

taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day

Placebo Comparator: Control

taking placebo drug

Drug: Placebo

taking placebo drug

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	463-707

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Jin S. Yeom, Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jin S. Yeom, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT02125981

Other Study ID Numbers:

LIMA_001

First Posted:

Apr 29, 2014

Last Update Posted:

May 5, 2022

Last Verified:

May 1, 2022

Keywords provided by Jin S. Yeom, Professor, Seoul National University Hospital

limaprost alfadex

cervical myelopathy

surgery

Additional relevant MeSH terms:

Spinal Cord Diseases

Bone Marrow Diseases

Study Results

No Results Posted as of May 5, 2022