The Study About the Efficacy of Oral Limaprost After Surgery for Cervical Myelopathy
A Prospective Randomized Double-blinded Clinical Trial About the Efficacy of Oral Limaprost Administration Following Surgery for Cervical Myelopathy
1 other identifier
interventional
160
1 country
1
Brief Summary
The limaprost alfadex can improve the surgical outcomes in patients with cervical myelopathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2014
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2014
CompletedFirst Posted
Study publicly available on registry
April 29, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedApril 14, 2023
April 1, 2023
8.1 years
April 24, 2014
April 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Limaprost
EXPERIMENTALtaking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day
Control
PLACEBO COMPARATORtaking placebo drug
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Jin S. Yeom
Seoul National University Bundang Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 24, 2014
First Posted
April 29, 2014
Study Start
September 1, 2014
Primary Completion
October 1, 2022
Study Completion
April 1, 2023
Last Updated
April 14, 2023
Record last verified: 2023-04