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

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ClinicalTrials.gov Identifier: NCT02125981
Recruitment Status : Recruiting
First Posted : April 29, 2014
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Jin S. Yeom, Seoul National University Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 1, 2014
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Japanese Orthopedic Association (JOA) recovery rates [ Time Frame: up to 12 months after operation ]
    JOA recovery rate = [(postoperative JOA score) - (preoperative JOA score)] / [(17-(preoperative JOA score)] x 100 (%).


Secondary Outcome Measures :
  1. Visual Analog Pain Scale for neck pain [ Time Frame: up to 12 months after operation ]
  2. Neck disability index score [ Time Frame: up to 12 months after operation ]
  3. Japanese orthopaedic association Cervical Myelopathy Evaluation Questionnaire score [ Time Frame: up to 12 months after operation ]
  4. Questionnaire Short Form 12 [ Time Frame: up to 12 months after operation ]
  5. Japanese orthopaedic association score [ Time Frame: up to 12 months after surgery ]
  6. assessment of the efficacy of positron emission tomography (PET) [ Time Frame: up to 12 months after operation ]
    The assessment of the efficacy of PET for prediction of drug (Limaprost) effect



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02125981


Contacts
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Contact: Jin S. Yeom, MD 82-31-787-7195 highcervical@gmail.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Jin S. Yeom, MD    +82-31-787-7915    highcervical@gmail.com   
Principal Investigator: Jin S. Yeom, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jin S. Yeom Seoul National University Bundang Hospital

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Responsible Party: Jin S. Yeom, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02125981     History of Changes
Other Study ID Numbers: LIMA_001
First Posted: April 29, 2014    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

Keywords provided by Jin S. Yeom, Seoul National University Hospital:
limaprost alfadex
cervical myelopathy
surgery

Additional relevant MeSH terms:
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Spinal Cord Diseases
Bone Marrow Diseases
Central Nervous System Diseases
Nervous System Diseases
Hematologic Diseases
Alprostadil
Platelet Aggregation Inhibitors
Vasodilator Agents
Urological Agents