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Completed

NCT Number: NCT02125981

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

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

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Key information

Conditions

Cervical Myelopathy

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Limaprost

Drug

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

Placebo

Drug

taking placebo drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2022
Study completion
2023
First posted
Apr 29, 2014
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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