Feasibility of Early Gabapentin as an Intervention for Neurorecovery

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
MetroHealth Medical Center
Study ID
NCT05302999
Phase
PHASE4
Status
Recruiting
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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gabapentin — DRUG
    Generic gabapentin
  • Placebo — DRUG
    Inert cellulose

Study Details

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.

Key Dates

Start date
Mar 14, 2022
Status verified
Nov 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low dose
    600mg treatment group will receive 2 capsules of gabapentin by mouth 3 times per day for 90 days.
  • Experimental: Medium dose
    1800 mg treatment groups will receive 2 capsules of gabapentin by mouth 3 times per day for 90 days.
  • Placebo Comparator: Control
    The control group will receive 2 placebo capsules of inert cellulose by mouth 3 times per day for 90 days.

Primary Outcome Measure

Number of participants recruited [ Time Frame: During the first 120 hours post-injury ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MetroHealth Medical CenterClevelandOhio44109
Mayson Moore
[email protected]
216-957-3518

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MetroHealth Medical Center· Cleveland, OH

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