Prophylactic Pregabalin Treatment Following Spinal Cord I... | NCT06066918

Studies
Prophylactic Pregabalin Treatment Following Spinal Cord Injury

NCT06066918

Sponsor

Loewenstein Hospital

Status

Recruiting

Last Update Posted

Jun 24, 2025Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Spinal Cord Injuries
Spinal Cord Diseases

Interventions

Pregabalin 75mg

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 13, 2021Actual

Primary Completion Date

Feb 5, 2026Estimated

Completion Date

Feb 5, 2026Estimated

First Submitted Date

Sep 28, 2023

First Submission Date that Met QC Criteria

Sep 28, 2023

First Posted Date

Oct 4, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2025

Last Update Posted Date

Jun 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregabalin	Experimental	Pregabalin 75 mg X2	Drug: Pregabalin 75mg
No treatment	No Intervention	no treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pregabalin 75mg	Drug	Pregabalin 75 mg twice a day	Pregabalin	Lyrica

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Central pain	development of central pain by interview (yes /no )	1 year
McGill Pain Questionnaire	Range 0 -78. higher scores mean worse outcome.	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Up to 3 months following traumatic or non-traumatic SCL
Ability to give informed consent and cooperate

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amiram Catz, Prof.	Contact	972-9-770-9934		amiramc@clalit.org.il

Overall Officials

Name	Affiliation	Role
Amiram Catz, Catz	Loewenstein Rehabilitation Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Loewenstein Rehabilitation Hospital	Recruiting	Raanana			Israel

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 1, 2023	Jan 30, 2024	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries
D013118	Spinal Cord Diseases

Ancestor Terms

ID	Term
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069583	Pregabalin

Ancestor Terms

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided