Health TrialsbyHealthPanel

Feasibility of Early Gabapentin as an Intervention for Neurorecovery

ConditionSpinal Cord Injuries
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMetroHealth Medical Center

About this trial

The objective of the proposed study is to conduct the first ever prospective, dose-exploration trial to test the feasibility of early administration of gabapentin as an intervention for neurorecovery. This research project falls under the Intervention Development stage of research as the primary goal is to assess the feasibility of conducting a well-designed intervention efficacy study in the future.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Traumatic SCI;

All levels of SCI;

All severities of SCI, AIS A-D;

Age 18 years and older.

Disqualifiers

Presence of moderate/severe traumatic brain injury (TBI) as defined by Glasgow Coma Score (GCS) < 13 at 120 hours' post-injury.

Documented use of gabapentinoids at the time of injury.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gabapentin

    Drug

    Generic gabapentin

  • Placebo

    Drug

    Inert cellulose

Treatment groups

42 Participants
are divided into 3 treatment groups
Group A: Low doseExperimental treatment 1 intervention
Group B: Medium doseExperimental treatment 1 intervention
Group C: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants recruited

Feasibility question - Can the target population be recruited? Feasibility measure - Number screened/month; number enrolled/month; reasons for not enrolling Quantitative benchmark of success - Screen an average of 4/month; Enroll an average of 1/month

Time frame
During the first 120 hours post-injury
2

Adherence rate to drug treatment protocol

Feasibility question - Can the drug treatment protocol be delivered? Feasibility measure - Proportion of enrolled who receive the full drug treatment protocol (placebo arm; two gabapentin dose arms); number of dosing deviations/arm; reasons for dosing deviations Quantitative benchmark of success - 70% enrolled in placebo arm receive full dosing protocol; 70% enrolled in each gabapentin arm receive full dosing protocol

Time frame
Across 90 day treatment window
3

Number of occurrences of unblinding

Feasibility question - Can the assessors remain blinded? Feasibility measure - Number of occurrences of unblinding; reasons for unblinding Quantitative benchmark of success - 5% or fewer occurrences of unblinding

Time frame
Across 6 month study duration per participant
4

Retention rate

Feasibility question - Will participants complete the study? Feasibility measure - Retention rate; reasons for dropout; proportion of planned assessments completed Quantitative benchmark of success - 70% of participants stay enrolled until the end of the study and complete 3 of the 4 assessment visits

Time frame
Across 6 month study duration per participant

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MetroHealth Medical Center

Lead sponsor

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Source ClinicalTrials.gov
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