Spinal Cord InjuriesPhase 4NCT03748290
Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among SCI
A Phase 4 study testing Pregabalin in people with Spinal Cord Injuries and Central Pain Syndrome, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Central neuropathic pain (CNP) is defined as chronic pain due to injury or disease in the central nervous system. This pain is most common among people with a spinal cord injuries (SCI), with a prevalence of about 50%. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Central Pain Syndrome
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Aug 2018to Nov 2019
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with a Spinal injury below C3 2-3 weeks after the injury
- Cognitive, mental, and verbal state (understanding and speech) that allows for voluntary cooperation in research and compliance with instructions
Who cannot join
- Pregnant women
- Other neurological diseases (such as head trauma)
- Other systemic diseases that affect the sensation (such as uncontrolled diabetes).
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center rehabilitaion facility
Ramat Gan
Gabriel Zeilig, MD, 972-3-5303725, Gabi.Zeilig@sheba.health.gov.il
Gabriel Zeilig, MD
About this study
Official title: The Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among Spinal Cord Injury Patients Who Have Yet to Develop Central Pain
Central neuropathic pain (CNP) is defined as chronic pain due to injury or disease in the central nervous system. This pain is most common among people with a spinal cord injuries (SCI), with a prevalence of about 50%. The central pain usually develops within a few months of spinal cord injury - and this period is significance in terms of this research work. This pain is one of the most complex and challenging pain syndromes. One of the reasons for this stems from its adherence to most treatments. Another reason is that there is partial information about the mechanism responsible for its development. Animal studies suggest that it is possible to prevent and / or reduce its development or reduce its strength by preventive treatment (given immediately after the injury). Currently, the treatments found to prevent or reduce central pain in animals are anti Inflammation and neuronal excitability suppressors such as interleukin 10.
The purpose of this study,is to explore whether pre-treatment with pregabalin prior to the development of the central pain will prevent the incidence of pain or reduce its intensity by improving pain regulation and reducing hypersensitivity.
Read more
The goal of the pharmacotherapy is to reduce the hypersensitivity- lyrica is used to reduce chronic neuropathic pain by reducing the degree of hypersensitivity in the pain system.
the objectives of this study are to examine whether early treatment of central pain can prevent or reduce the incidence of pain by improving pain regulation and reducing hypersensitivity. That is, whether there will be a difference between those who take Lyrica-Pregabalin (a drug that reduces hypersensitivity of pain) compared to placebo.
Methods: A randomized, double-blind, placebo-controlled study in which people with a fresh SCI will receive lyrica or placebo as soon as possible from their arrival at the rehabilitation hospital for 2-3 months during which pain system characteristics will be measured and monitored for central pain development.
- Conditions
- Spinal Cord Injuries, Central Pain Syndrome
- Being tested
- Pregabalin, Placebo Oral Tablet
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
Pregabalin 75 mg for 12 weeks
Placebo Oral TabletDrug
Placebo Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| People with a SCI who will receive Lyrica 75mg for 12 weeks | Experimental | Not described Receives: Drug: Pregabalin |
| People with a SCI who will receive Placebo for 12 weeks | Placebo comparator | Not described Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Pain: monitored for any complaints
Subjects will be constantly monitored for any complaints of pain and the pain will be diagnosed. Upon a diagnosis of central neuropathic pain, the first outcome is achieved
Measured: 12 weeks
Central neuropathic pain severity: McGill pain questionnaire
Two major quantitative parameters are derived: (1) the number of words chosen (NWC) by the subject from a list of descriptors (total score ranges between 0-19), and (2) the pain rating index (PRI)- based on summing the rank values of these words (total score ranges between 0-65). Higher values represent worse outcome.
Measured: 12 weeks
Pain modulation capacity - Visual analog scale (VAS)
0=no pain, 10=most intense pain imaginable, Higher values in the VAS represent worse outcome. This outcome will be assessed with the conditioned pain modulation and the temporal summation experimental paradigms.
The Conditioned Pain Modulation (CPM) paradigm is an experimental paradigm the results of which indicate on the capacity of the pain modulation systems. The magnitude of CPM will be the outcome measure and it is calculated by subtracting a pain rating on the VAS of a noxious stimulus administered alone and in the presence of another, remote stimulus.
The temporal summation of pain (TSP) paradigm is an experimental paradigm the results of which indicate on the level of excitability of the pain system. The magnitude of TSP will be the outcome measure and it is calculated by subtracting a pain rating on the VAS given at the termination of a continuous noxious stimulus from that given at the beginning of the same stimulus.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start23 Aug 2018
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv University
- Responsible party
- Principal investigator, Dr. Gabriel Zeilig, Sheba Medical Center
- Investigators
- Gabi Zeilig, Prof., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748290
- Sponsor's protocol ID
- 4686-17-SMC
- Status last verified
- Nov 2018
- First submitted
- 12 Nov 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among Spinal Cord Injury Patients Who Have Yet to Develop Central Pain
- ClinicalTrials.gov ID
- NCT03748290
- Acronym / sponsor ID
- 4686-17-SMC
- Conditions
- Spinal Cord Injuries, Central Pain Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Tel Aviv University
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 20 Nov 2018 (actual)
- 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.
Central neuropathic pain (CNP) is defined as chronic pain due to injury or disease in the central nervous system. This pain is most common among people with a spinal cord injuries (SCI), with a prevalence of about 50%. The central pain usually develops within a few months of spinal cord injury - and this period is significance in terms of this research work. This pain is one of the most complex and challenging pain syndromes. One of the reasons for this stems from its adherence to most treatments. Another reason is that there is partial information about the mechanism responsible for its development. Animal studies suggest that it is possible to prevent and / or reduce its development or reduce its strength by preventive treatment (given immediately after the injury). Currently, the treatments found to prevent or reduce central pain in animals are anti Inflammation and neuronal excitability suppressors such as interleukin 10.
The purpose of this study,is to explore whether pre-treatment with pregabalin prior to the development of the central pain will prevent the incidence of pain or reduce its intensity by improving pain regulation and reducing hypersensitivity.
The goal of the pharmacotherapy is to reduce the hypersensitivity- lyrica is used to reduce chronic neuropathic pain by reducing the degree of hypersensitivity in the pain system.
the objectives of this study are to examine whether early treatment of central pain can prevent or reduce the incidence of pain by improving pain regulation and reducing hypersensitivity. That is, whether there will be a difference between those who take Lyrica-Pregabalin (a drug that reduces hypersensitivity of pain) compared to placebo.
Methods: A randomized, double-blind, placebo-controlled study in which people with a fresh SCI will receive lyrica or placebo as soon as possible from their arrival at the rehabilitation hospital for 2-3 months during which pain system characteristics will be measured and monitored for central pain development.
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 |
|---|---|---|
| People with a SCI who will receive Lyrica 75mg for 12 weeks | Experimental | Drug: Pregabalin |
| People with a SCI who will receive Placebo for 12 weeks | Placebo comparator | Drug: Placebo Oral Tablet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- People with a Spinal injury below C3 2-3 weeks after the injury
- Cognitive, mental, and verbal state (understanding and speech) that allows for voluntary cooperation in research and compliance with instructions
Key exclusion criteria (3 listed)
- Pregnant women
- Other neurological diseases (such as head trauma)
- Other systemic diseases that affect the sensation (such as uncontrolled diabetes).
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 |
|---|---|---|
| PregabalinAlso: LyricaPregabalin 75 mg for 12 weeks | Drug | People with a SCI who will receive Lyrica 75mg for 12 weeks |
| Placebo Oral TabletPlacebo Oral Tablet | Drug | People with a SCI who will receive Placebo for 12 weeks |
Primary outcome
Central Pain: monitored for any complaints
Time frame: 12 weeks
Subjects will be constantly monitored for any complaints of pain and the pain will be diagnosed. Upon a diagnosis of central neuropathic pain, the first outcome is achieved
Central neuropathic pain severity: McGill pain questionnaire
Time frame: 12 weeks
Two major quantitative parameters are derived: (1) the number of words chosen (NWC) by the subject from a list of descriptors (total score ranges between 0-19), and (2) the pain rating index (PRI)- based on summing the rank values of these words (total score ranges between 0-65). Higher values represent worse outcome.
Pain modulation capacity - Visual analog scale (VAS)
Time frame: 12 weeks
0=no pain, 10=most intense pain imaginable, Higher values in the VAS represent worse outcome. This outcome will be assessed with the conditioned pain modulation and the temporal summation experimental paradigms. The Conditioned Pain Modulation (CPM) paradigm is an experimental paradigm the results of which indicate on the capacity of the pain modulation systems. The magnitude of CPM will be the outcome measure and it is calculated by subtracting a pain rating on the VAS of a noxious stimulus administered alone and in the presence of another, remote stimulus. The temporal summation of pain (TSP) paradigm is an experimental paradigm the results of which indicate on the level of excitability of the pain system. The magnitude of TSP will be the outcome measure and it is calculated by subtracting a pain rating on the VAS given at the termination of a continuous noxious stimulus from that given at the beginning of the same stimulus.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
Gabi Zeilig, Prof. principal investigator
Sheba Medical Center
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 Pregabalin in people with Spinal Cord Injuries and Central Pain Syndrome, run by Sheba Medical Center at 1 site in Israel.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Nov 2018. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabi Zeilig, Prof. (972-3-5303725, gabi.zeilig@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Pain: monitored for any complaints (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 20 Nov 2018.