Spinal Cord InjuryPhase 4NCT01579500
Neuropathic Pain Study With Botulinum Toxin A in Spinal Cord Injury Patients
A Phase 4 study testing Botulinum toxin type A and normal saline in people with Spinal Cord Injury and Neuropathic Pain, run by Catholic University of Korea Saint Paul's Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether botulinum toxin A is effective in the treatment of neuropathic pain in spinal cord injury patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Spinal Cord Injury, Neuropathic Pain
- What is being tested?
- Botulinum toxin type A and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to Apr 2013
- Phase
- Phase 4
- 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
- more than twenty years of age
- paraplegic or tetraplegic due to cervical and thoracic spinal cord injury
- more than 12 months since spinal cord injury and ASIA impairment scale unchanged for more than 6 months
- persistence of neuropathic pain for more than three months or remission and recurrence of neuropathic pain for more than six months
- a pain score of 40mm or more on the visual analogue scale
Who cannot join
- neuropathic pain caused by confounding factors other than spinal cord injury
- contraindicated for botulinum toxin type A
- a change in pain medication one month prior to study enrollment
- a condition involving neuromuscular junction (Ex. Eaton Lambert disease, myasthenia gravis)
- person who received botulinum toxin type A within three months prior to study enrollment
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Catholic University Saint Paul's Hospital; National Health Insurance Corporation Ilsan Hospital
Seoul
About this study
Official title: The Effect of Botulinum Toxin A in Post Spinal Cord Injury Neuropathic Pain
The purpose of this study is to determine whether botulinum toxin A is effective in the treatment of neuropathic pain in spinal cord injury patients.
Read the detailed description
Neuropathic pain remains a significant cause of life quality deterioration. This study includes spinal cord injury patients with refractory chronic neuropathic pain and investigates whether injection with botulinum toxin A improves pain scores.
- Conditions
- Spinal Cord Injury, Neuropathic Pain
- Being tested
- Botulinum toxin type A, normal saline
- Medical subject headings
- Spinal Cord Injuries, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous injection of botulinum toxin type A
normal salineDrug
Subcutaneous injection of normal saline
| Study group | Role | What they receive |
|---|---|---|
| botulinum toxin A | Active comparator | Not described Receives: Drug: Botulinum toxin type A |
| normal saline | Placebo comparator | Not described Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
Measured: 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of Korea Saint Paul's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Insurance Service Ilsan Hospital, Medy-Tox
- Responsible party
- Principal investigator, Myung Eun, Chung, Catholic University of Korea Saint Paul's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579500
- Sponsor's protocol ID
- PC12MIMV0005
- Other IDs
- 20120007154, suyon 2011-131
- Status last verified
- Apr 2013
- First submitted
- 16 Apr 2012
- Last updated
- 25 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Botulinum Toxin A in Post Spinal Cord Injury Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01579500
- Acronym / sponsor ID
- PC12MIMV0005
- Conditions
- Spinal Cord Injury, Neuropathic Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Catholic University of Korea Saint Paul's HospitalUniversity, hospital or other
- Collaborators
- National Health Insurance Service Ilsan Hospital, Medy-Tox
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Apr 2012 (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 purpose of this study is to determine whether botulinum toxin A is effective in the treatment of neuropathic pain in spinal cord injury patients.
Detailed description
Neuropathic pain remains a significant cause of life quality deterioration. This study includes spinal cord injury patients with refractory chronic neuropathic pain and investigates whether injection with botulinum toxin A improves pain scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin A | Active comparator | Drug: Botulinum toxin type A |
| normal saline | Placebo comparator | Drug: normal saline |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- more than twenty years of age
- paraplegic or tetraplegic due to cervical and thoracic spinal cord injury
- more than 12 months since spinal cord injury and ASIA impairment scale unchanged for more than 6 months
- persistence of neuropathic pain for more than three months or remission and recurrence of neuropathic pain for more than six months
- a pain score of 40mm or more on the visual analogue scale
Key exclusion criteria (5 listed)
- neuropathic pain caused by confounding factors other than spinal cord injury
- contraindicated for botulinum toxin type A
- a change in pain medication one month prior to study enrollment
- a condition involving neuromuscular junction (Ex. Eaton Lambert disease, myasthenia gravis)
- person who received botulinum toxin type A within three months prior to study enrollment
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 |
|---|---|---|
| Botulinum toxin type ASubcutaneous injection of botulinum toxin type A | Drug | botulinum toxin A |
| normal salineSubcutaneous injection of normal saline | Drug | normal saline |
Primary outcome
Visual analogue scale
Time frame: 4 weeks after intervention
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 25 Apr 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum toxin type A and normal saline in people with Spinal Cord Injury and Neuropathic Pain, run by Catholic University of Korea Saint Paul's 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 5 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 25 Apr 2013. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Visual analogue scale (time frame: 4 weeks after intervention). 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 25 Apr 2013.