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Anti-epileptic drug

Gabapentin for Pain

Phase 2
Waitlist Available
Led By Hal Siden, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 of sequence 1 and 2 (each sequence is 26 days with a 3 day washout period in between) and study end, day 55
Awards & highlights

Study Summary

This study is evaluating whether a drug called gabapentin might help reduce pain in children with developmental brain disorders.

Eligible Conditions
  • Pain
  • Neuropathic Pain
  • Irritability

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of sequence 1 and 2 (each sequence is 26 days with a 3 day washout period in between) and study end, day 55
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of sequence 1 and 2 (each sequence is 26 days with a 3 day washout period in between) and study end, day 55 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean pain and irritability score
Secondary outcome measures
Adverse Events collection
Identification of latency time
Identification of lowest effective dose
+1 more
Other outcome measures
Improvement in parent fatigue levels

Side effects data

From 2021 Phase 4 trial • 88 Patients • NCT03012815
2%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gabapentin
Benzodiazepine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MedicationExperimental Treatment1 Intervention
Gabapentin is clinically started at a low dose and titrated to clinical effect or maximum target dose, whichever is lower. The starting dose of gabapentin will be 5 mg/kg administered as oral liquid or via gastric or jejunal routes. On Day 1 of the study, the gabapentin will be administered once at bedtime and then increased according to a preset schedule. The dose will be increased every 3rd - 4th day in a step wise fashion of 13% - 50%, starting with the evening dose in order to accommodate sedation. The maximum dose for subjects will be as follows: < 15 kg to 60 mg/kg day and ≥15 kg to 45 mg/kg/day.
Group II: PlaceboPlacebo Group1 Intervention
Participants on this arm receive placebo, masked and dispensed according to the same preset schedule as the Medication arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gabapentin
FDA approved

Find a Location

Who is running the clinical trial?

BC Children's Hospital Research InstituteOTHER
12 Previous Clinical Trials
2,332 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,453,407 Total Patients Enrolled
11 Trials studying Pain
2,131 Patients Enrolled for Pain
Child-Bright NetworkOTHER
3 Previous Clinical Trials
960 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Efficacy of Gabapentin in Treating Pain in Children With SNI (Gabapentin Trial)
Harold Siden 2021. "Efficacy of Gabapentin in Treating Pain in Children With SNI (Gabapentin Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04619862.
All > Gabapentin
~3 spots leftby Apr 2025
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