The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03255330

Acronym

GabaNeuBol

Enrollment

Registered

2017-08-21

Start date

2017-10-31

Completion date

2020-08-31

Last updated

2019-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain Due to Trauma, Spinal Cord Injuries

Brief summary

Study of the effect of gabapentin used as a preemptive to the emergence and development chronic neuropathic pain in patients after spinal cord trauma

Interventions

DRUGGabapentin

Gabapentin will be given approximately 3 months until no chronic neuropathic pain is present

DRUGMetamizol

Standardized treatment

DRUGTramadol

Standardized treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Men and women, age 18 - 65 years 2. Signed written informed consent 3. Patients after complete/non-complete spinal lesion, after surgery 4. Patients with spinal cord trauma caused mechanically demanding (due a injury of a bone fragment, a disk, a translation spinal canal) 5. Patient willing and able to comply with the study protocol 6. Male and females with a highly effective method of birth control plus an additional barrier method

Exclusion criteria

1. Patients with spinal cord lesion ischemic etiology 2. Pregnant women, nursing or childbearing age with a positive pregnancy test input 3. Patients unable or unwilling to comply with the study protocol 4. Acute pancreatitis in 1 year from the start of the study 5. Chronic pancreatitis in the case history 6. Active or uncontrolled infectious diseases 7. Hypersensitivity to any component of the investigational product 8. Active autoimmune disease 9. Serious neurological disease with the incidence chronic neuropathic pain

Design outcomes

Primary

Measure	Time frame	Description
Assessment the analgesic effect of gabapentin	in 3 months after initiation of the gabapentin treatment	The decrease of the incidence of chronic neuropathic pain in 3 months after initiation of the gabapentin treatment in 3 months after initiation of the gabapentin treatment

Secondary

Measure	Time frame	Description
The decrease of the incidence of chronic neuropathic pain	in 6., 9. and 12. months after initiation of the gabapentin treatment	The decrease of the incidence of chronic neuropathic pain in 6., 9. and 12. months after initiation of the gabapentin treatment
The number of painful episodes	in 3., 6., 9. and 12. months after initiation of the gabapentin treatment	The number of painful episodes requiring treatment of rescue medication (in 3., 6., 9. and 12. months after initiation of the gabapentin treatment)
The decrease of the consumption of rescue medication	in 3., 6., 9. and 12. months after initiation of the gabapentin treatment	The decrease of the consumption of rescue medication in 3., 6., 9. and 12. months after initiation of the gabapentin treatment
Absolute and percentage change in average pain	in 3., 6., 9. and 12. months	Absolute and percentage change in average pain after initiation of therapy with gabapentin (baseline) in 3., 6., 9. and 12. months
Quality of life	in week 1, 3., 6., 9. and 12. months after initiation of the gabapentin treatment	Quality of life, assessment of neurological pain and psychological state measured by questionnaires PainDETECT, SQUALA and SCL-R

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026