← Back to Search

Anti-epileptic drug

Gabapentin for Neuropathic Pain in Children

Phase 2

Recruiting

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

Children aged 6 months to 18 years with severe neurological impairment (SNI) from any cause, experiencing unexplained pain and irritability

Children with cognitive impairment or non-verbal communication and classified as GMFCS scores 3, 4, or 5 and CFCS level 4 or 5

Must not have

Patients with active renal disease, known renal impairment, or glomerular filtration rate < 60 mL/min/1.73 m2

Patients with active nociceptive-inflammatory pain at enrolment (e.g., post-operative pain)

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

All Individual Drugs Already Approved

Summary

This trial aims to determine how effective gabapentin is in reducing and resolving pain in children with severe brain-based developmental disabilities. These children often experience unexplained periods of pain and irritability, and the

Who is the study for?

This trial is for children aged 6 months to 18 years with severe neurological impairment who experience unexplained pain and irritability. They must have significant communication or cognitive disabilities, scoring high on specific scales indicating persistent distress without an obvious cause.

What is being tested?

The trial tests the effectiveness of Gabapentin in alleviating pain compared to a placebo in children with severe brain-based developmental disabilities. It aims to determine how well Gabapentin can reduce or resolve their pain and irritability.

What are the potential side effects?

Gabapentin may cause side effects such as dizziness, sleepiness, water retention leading to swelling in limbs, difficulty walking, changes in behavior like restlessness or mood swings, nausea, and blurred vision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child, aged 6 months to 18 years, has severe neurological issues and unexplained pain or irritability.

Select...

My child has severe cognitive or communication issues and significant physical limitations.

Select...

My child often feels pain for no clear reason and it's very distressing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function is reduced with a filtration rate below 60 mL/min.

Select...

I am experiencing pain due to inflammation or after surgery.

Select...

I have been diagnosed with sickle cell disease.

Select...

I am not between 6 months and 18 years old.

Select...

My parents do not speak English or French.

Timeline

Screening ~ 3 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean pain and irritability score

Secondary study objectives

Adverse Events collection

Identification of latency time

Identification of lowest effective dose

+1 more

Other study objectives

Improvement in parent fatigue levels

Side effects data

From 2021 Phase 4 trial • 88 Patients • NCT03012815

Allergic reaction

100%

80%

60%

40%

20%

Study treatment Arm

Gabapentin

Benzodiazepine

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

0 / 8Eligibility criteria met