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

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Cervical Myelopathy

Treatments: Drug: Placebo; Drug: Limaprost

Study type: Interventional

Funder types: Other

Identifiers

NCT02125981

LIMA_001

Details and patient eligibility

About

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

Enrollment: 160 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

Limaprost

Experimental group

Description:

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

Treatment:

Drug: Limaprost

Control

Placebo Comparator group

Description:

taking placebo drug

Treatment:

Drug: Placebo