Evaluation of Initiation Time on the Efficacy of Gabapentin in Treating Neuropathic Pain in SCI

NCT04256603 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB19-00117
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Neuropathic pain is a common complaint in those with spinal cord injury (SCI) that has a significant negative effect on quality of life. Efficacy of various treatments, however, remains controversial. There is evidence to support that gabapentin and pregabalin have some benefit in reducing neuropathic pain. Gabapentin is effective in the management of symptoms and concerns related to SCI including motor recovery, spasticity, and mood among others. This makes gabapentin an important pharmacologic intervention, which compels providers to define treatment guidelines related to its use. One aspect of which should relate to the timing of initiation of therapy. The goal of this study is to determine whether timing of initiation of treatment with gabapentin will decrease prevalence and intensity of neuropathic pain.

Conditions

Spinal Cord Injuries; Neuropathic Pain

Keywords

neuropathic pain; spinal cord injury

Outcome Measures

Primary Outcomes (1)

• Neuropathic Pain

  To determine if the time from injury influences the prevalence of neuropathic pain in acute SCI. Average of the pain during the previous 7 days on self-identified nerve or neuropathic pain levels (0-10) on 5 different measurements at the time of discharge on the Neuropathic Pain Scale. 0 being best (no pain)- 10 being worst pain. Total score range from 0 to 50.

  Through completion of the study, up to 4 weeks after injury.

Study Arms (3)

Gabapentin early

OTHER

Gabapentin prior to admission

Drug: Gabapentin

Gabapentin late

OTHER

Gabapentin during admission

Drug: Gabapentin

No gabapentin

OTHER

No gabapentin

Other: No gabapentin

Interventions

Gabapentin DRUG

Timing of gabapentin initiation

Gabapentin early; Gabapentin late

No gabapentin OTHER

No gabapentin

No gabapentin

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of acute spinal cord injury
• Admission to acute inpatient rehabilitation

You may not qualify if:

• Unable to communicate verbally or by writing, unable to follow basic instructions, or unable to answer questions regarding their symptoms

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: c. kim
• Organization: MetroHealth

ckim3@metrohealth.com

216 778 7800

Study Officials

• C Kim

  Metro Health, Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: February 1, 2020
• First Posted: February 5, 2020
• Study Start: August 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: April 1, 2020
• Last Updated: November 15, 2021
• Results First Posted: November 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)