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Spinal Cord InjuriesPhase 4NCT04256603

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

A Phase 4 study testing Gabapentin and No gabapentin in people with Spinal Cord Injuries and Neuropathic Pain, run by MetroHealth Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Spinal Cord Injuries, Neuropathic Pain
What is being tested?
Gabapentin and No gabapentin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
1 Aug 2019to 1 Apr 2020
Phase
Phase 4

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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • MetroHealth

    Cleveland, Ohio, 44109

Other trials in United States

About this study

Official title: Evaluation of Initiation Time on the Efficacy of Gabapentin in Treating Neuropathic Pain in Spinal Cord Injury (SCI)

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.

Read the detailed description

Neuropathic pain is a common complaint in those with spinal cord injury (SCI) that has a significant negative effect on quality of life. This makes the treatment of neuropathic pain a priority in the SCI population. Efficacy of various treatments, however, remains controversial. There is evidence to support that gabapentin and pregabalin have some benefit in reducing neuropathic pain. Other positive effects of gabapentin on those with SCI have also been demonstrated. However, there has not been a study on the influence of timing of initiation of gabapentin on the efficacy of using it to treat neuropathic pain in the SCI population. Such a finding could change the standard of care in treatment of acute SCI.

The pooled prevalence of neuropathic pain post spinal cord injury is 53%. Not only common, neuropathic pain is pervasive, affecting aspects of patients' lives including sleep, physical function, and mood that in turn impact their activities- work and recreational alike. Thus, neuropathic pain management contributes to quality of life for a majority of people with SCI.

Although a high priority, the treatment of neuropathic pain in SCI remains notoriously difficult. Treatments options may be divided into pharmacologic and non-pharmacologic. Pharmacologic agents studied include amitriptyline, gabapentin, pregabalin, opiates, lidocaine, ketamine, valproate, lamotrigine, levetiracetam and carbamazepine; the most studied of which are amitriptyline, gabapentin, and pregabalin.

Gabapentin's potential is not limited to neuropathic pain management, making it a particularly compelling treatment option in the population with acute SCI. Gabapentin leads to improvement in total motor scores, reduced spasticity, reduced autonomic dysreflexia, and improved mood. Animal models suggest it may be neuroprotective in the acute phase of injury. In those who undergo spine surgery, regardless of presence of SCI, gabapentin given perioperatively leads to reduced opiate use and decreased pain in post-operative period. Additionally, when compared to narcotic alternatives, gabapentin has minimal side effects.

Neuropathic pain in SCI is common, impactful, and difficult to treat. 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 early initiation of treatment with gabapentin will decrease average pain scores and opiate use when comparted to late initiation of treatment with gabapentin in the population with acute SCI. Gabapentin, although used commonly, is not started in all patients with acute SCI but is often started at the onset of neuropathic pain. If gabapentin is found to be more effective when initiated early, it would be reasonable to start gabapentin immediately following acute SCI in all patients in whom it is not otherwise contraindicated.

Being tested
Gabapentin, No gabapentin
Keywords
neuropathic pain, spinal cord injury
Medical subject headings
Spinal Cord Injuries, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GabapentinDrug

    Timing of gabapentin initiation

  • No gabapentinOther

    No gabapentin

Study groups in NCT04256603
Study groupRoleWhat they receive
Gabapentin earlyOtherGabapentin prior to admission
Receives: Drug: Gabapentin
Gabapentin lateOtherGabapentin during admission
Receives: Drug: Gabapentin
No gabapentinOtherNo gabapentin
Receives: Other: No gabapentin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start1 Aug 2019
  3. Primary completion30 Mar 2020
  4. Study completion1 Apr 2020

Resources

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 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04256603
Sponsor's protocol ID
IRB19-00117
Status last verified
Nov 2021
First submitted
1 Feb 2020
Last updated
15 Nov 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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