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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02125981
Other study ID # LIMA_001
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
See also
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