Cervical MyelopathyPhase 3NCT02125981
The Study About the Efficacy of Oral Limaprost After Surgery for Cervical Myelopathy
A Phase 3 study testing Limaprost in people with Cervical Myelopathy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The limaprost alfadex can improve the surgical outcomes in patients with cervical myelopathy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cervical Myelopathy
- What is being tested?
- Limaprost
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2014to 1 Apr 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: A Prospective Randomized Double-blinded Clinical Trial About the Efficacy of Oral Limaprost Administration Following Surgery for Cervical Myelopathy
The limaprost alfadex can improve the surgical outcomes in patients with cervical myelopathy.
- Conditions
- Cervical Myelopathy
- Being tested
- Limaprost, Placebo
- Keywords
- limaprost alfadex, cervical myelopathy, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LimaprostDrug
taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day
PlaceboDrug
taking placebo drug
| Study group | Role | What they receive |
|---|---|---|
| Limaprost | Experimental | taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day Receives: Drug: Limaprost |
| Control | Placebo comparator | taking placebo drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Japanese Orthopedic Association (JOA) recovery rates
JOA recovery rate = [(postoperative JOA score) - (preoperative JOA score)] / [(17-(preoperative JOA score)] x 100 (%).
Measured: up to 12 months after operation
Secondary outcomes (6)
Visual Analog Pain Scale for neck pain
Measured: up to 12 months after operation
Neck disability index score
Measured: up to 12 months after operation
Japanese orthopaedic association Cervical Myelopathy Evaluation Questionnaire score
Measured: up to 12 months after operation
Questionnaire Short Form 12
Measured: up to 12 months after operation
Japanese orthopaedic association score
Measured: up to 12 months after surgery
assessment of the efficacy of positron emission tomography (PET)
The assessment of the efficacy of PET for prediction of drug (Limaprost) effect
Measured: up to 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study start1 Sep 2014
- Primary completion1 Oct 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical MyelopathyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin S. Yeom, Seoul National University Hospital
- Investigators
- Jin S. Yeom, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125981
- Sponsor's protocol ID
- LIMA_001
- Status last verified
- Apr 2023
- First submitted
- 24 Apr 2014
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Double-blinded Clinical Trial About the Efficacy of Oral Limaprost Administration Following Surgery for Cervical Myelopathy
- ClinicalTrials.gov ID
- NCT02125981
- Acronym / sponsor ID
- LIMA_001
- Conditions
- Cervical Myelopathy
- Keywords
- limaprost alfadex, cervical myelopathy, surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 29 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The limaprost alfadex can improve the surgical outcomes in patients with cervical myelopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Limaprost | Experimental | Drug: Limaprosttaking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day |
| Control | Placebo comparator | Drug: Placebotaking placebo drug |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Limaprosttaking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day | Drug | Limaprost |
| Placebotaking placebo drug | Drug | Control |
Primary outcome
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 (%).
6 secondary outcomes
Visual Analog Pain Scale for neck pain
Time frame: up to 12 months after operation
Neck disability index score
Time frame: up to 12 months after operation
Japanese orthopaedic association Cervical Myelopathy Evaluation Questionnaire score
Time frame: up to 12 months after operation
Questionnaire Short Form 12
Time frame: up to 12 months after operation
Japanese orthopaedic association score
Time frame: up to 12 months after surgery
assessment of the efficacy of positron emission tomography (PET)
Time frame: up to 12 months after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin S. Yeom principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Limaprost in people with Cervical Myelopathy, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Japanese Orthopedic Association (JOA) recovery rates (time frame: up to 12 months after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.