Spinal Cord InjuriesNCT06066918
Prophylactic Pregabalin Treatment Following Spinal Cord Injury
A study testing Pregabalin 75mg in people with Spinal Cord Injuries and Spinal Cord Diseases, run by Loewenstein Hospital at 1 site in Israel.
Trial summary
Patients arriving to rehabilitation up to 3 months following SCI will be given (study group) or not (control group) Lyrica (75X2). They will be followed for central pain development. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Diseases
- What is being tested?
- Pregabalin 75mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 13 Jul 2021to 5 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Up to 3 months following traumatic or non-traumatic SCL
- Ability to give informed consent and cooperate
Who cannot join
- Pregnancy
- Neurological or other medical conditions that may interfere with sensation
- Neuropathic-like pain before recruitment (described as painful sensation of electric current, burning, numbness, tingling, pricking, or squeezing)
- Being treated with Pregabalin
- Blood creatinine levels >1.2 or creatinine clearance <60
- Sensitivity to lactose
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Loewenstein Rehabilitation Hospital
Raanana
Sara Lipkin
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
Patients arriving to rehabilitation up to 3 months following SCI will be given (study group) or not (control group) Lyrica (75X2). They will be followed for central pain development.
Read the detailed description
Patients arriving to rehabilitation up to 3 months following SCI will be recruited, if they have not yet developed central pain. Two thirds (the study group) will be treated with Lyrica (Pregabalin75X2) for 3 months. One third (the control group) will not receive preventative treatment. Participants will be followed for central pain development.
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases
- Being tested
- Pregabalin 75mg
- Medical subject headings
- Spinal Cord Injuries, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 75mgDrug
Also called Lyrica
Pregabalin 75 mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Experimental | Pregabalin 75 mg X2 Receives: Drug: Pregabalin 75mg |
| No treatment | No intervention | no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central pain
development of central pain by interview (yes /no )
Measured: 1 year
McGill Pain Questionnaire
Range 0 -78. higher scores mean worse outcome.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start13 Jul 2021
- Primary completion5 Feb 2026 (estimated)
- Study completion5 Feb 2026 (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.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- allocation will be sequential. 2 patients will be in the study group, followed by one patient at the control group.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loewenstein Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, amiram-catz, Loewenstein Hospital
- Investigators
- Amiram Catz, Catz, Principal investigator, Loewenstein Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066918
- Sponsor's protocol ID
- 0012-19-LOE
- Status last verified
- Jun 2025
- First submitted
- 28 Sep 2023
- Last updated
- 24 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. 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
- NCT06066918
- Acronym / sponsor ID
- 0012-19-LOE
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Loewenstein HospitalUniversity, hospital or other
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 5 Feb 2026 (estimated)
- Study completion
- 5 Feb 2026 (estimated)
- First posted
- 4 Oct 2023 (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.
Patients arriving to rehabilitation up to 3 months following SCI will be given (study group) or not (control group) Lyrica (75X2). They will be followed for central pain development.
Detailed description
Patients arriving to rehabilitation up to 3 months following SCI will be recruited, if they have not yet developed central pain. Two thirds (the study group) will be treated with Lyrica (Pregabalin75X2) for 3 months. One third (the control group) will not receive preventative treatment. Participants will be followed for central pain development.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- allocation will be sequential. 2 patients will be in the study group, followed by one patient at the control group.
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Experimental | Drug: Pregabalin 75mgPregabalin 75 mg X2 |
| No treatment | No intervention | –no treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Up to 3 months following traumatic or non-traumatic SCL
- Ability to give informed consent and cooperate
Key exclusion criteria (6 listed)
- Pregnancy
- Neurological or other medical conditions that may interfere with sensation
- Neuropathic-like pain before recruitment (described as painful sensation of electric current, burning, numbness, tingling, pricking, or squeezing)
- Being treated with Pregabalin
- Blood creatinine levels >1.2 or creatinine clearance <60
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 |
|---|---|---|
| Pregabalin 75mgAlso: LyricaPregabalin 75 mg twice a day | Drug | Pregabalin |
Primary outcome
Central pain
Time frame: 1 year
development of central pain by interview (yes /no )
McGill Pain Questionnaire
Time frame: 3 months
Range 0 -78. higher scores mean worse outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
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.
Amiram Catz, Catz principal investigator
Loewenstein Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin 75mg in people with Spinal Cord Injuries and Spinal Cord Diseases, run by Loewenstein Hospital 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 6 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: looking for participants now, as of the sponsor's last update on 24 Jun 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amiram Catz, Prof. (972-9-770-9934, amiramc@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central pain (time frame: 1 year). The study lists 2 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 24 Jun 2025.