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

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

Study Overview

• Status: Withdrawn
• Conditions: Spinal Cord Injuries; Chronic Pain Due to Trauma
• Intervention / Treatment: Drug: Gabapentin; Drug: Metamizol; Drug: Tramadol

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia
    • Fakultni nemocnice Brno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm G1800; administration of gabapentin with a gradual increasing dose of up to 1800 mg / day	Drug: Gabapentin; Gabapentin will be given approximately 3 months until no chronic neuropathic pain is present; Other Names: Gabapentinum
Active Comparator: G0; Standardized medical treatment of central neuropathic pain: metamizole, tramadol	Drug: Metamizol; Standardized treatment; Drug: Tramadol; Standardized treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment the analgesic effect of gabapentin	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	in 3 months after initiation of the gabapentin treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Masaryk University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2017
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 5, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Chronic Pain; Neuralgia; Wounds and Injuries; Spinal Cord Injuries; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antipyretics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin; Tramadol; Dipyrone
• Other Study ID Numbers: GNB-2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No