Recruiting
Phase 2

Gabapentin

Sponsor:

University of British Columbia

Code:

NCT04619862

Conditions

Pain

Neuropathic Pain

Irritability

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Gabapentin

Placebo

Study Details

Brief summary:

Children born with severe brain-based developmental disabilities frequently experience persistent unexplained periods of pain and irritability, often compounded by a limited capacity to communicate their distress. The investigators call this entity Pain and Irritability of Unknown Origin (PIUO). The rationale of this trial is to identify the clinical effect size of gabapentin in reducing and resolving pain in children with developmental brain disorders, specifically those with severe neurological impairment (SNI).

Conditions

Pain

Neuropathic Pain

Irritability

Study ID

NCT04619862

Start date

May 15, 2021

Status verified date

May, 2024

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children aged 6 months to 18 years with SNI (from any cause) with unexplained pain and irritability and whose cognitive or communication impairments prevent determination of pain location, cause, and type will be eligible to participate.
  • Eligible children will have cognitive impairment or be non-verbal and have severe levels of disability equivalent to Gross Motor Functional Classification System (GMFCS) scores of 3, 4 or 5 as well as Communication Function Classification System (CFCS) level 4 or 5.
  • Eligible children will score >3 on two scales administered via an Eligibility Screening that measures persistence and distress level the child is experiencing as well as identifies the type of pain and irritability as PIUO - with no obvious cause or explanation. The score of >3 on the scale measuring pain persistence and distress level confirms that the child is experiencing pain and irritability more than "a little" on "some days".
  • The will be evidence of a comprehensive evaluation of PIUO in the child's medical history, showing no evidence for treatable sources (nociceptive-inflammatory) of pain and/or irritability symptoms.

Exclusion Criteria:

  • Children not within the specified age range
  • Children with communication capabilities and cognitive development to localize their pain.
  • Participants whose pain and or irritability is diagnosed through completion of the PIUO Pathway during the enrollment phase of the trial.
  • Patients with a known hypersensitivity/allergy to the study medication
  • Patients who are actively participating in another experimental therapy study for pain and/or irritability.
  • Patients who are a poor medical risk because of other systemic diseases or active uncontrolled infections.
  • Patients who score A or B on the Pain Survey
  • Patients who have an active source of nociceptive-inflammatory pain at the time of enrolment (e.g., post-operative pain)
  • Patients with active renal disease, known renal impairment or glomerular filtration rate < 60 mL/min/1.73 m2 (if known).
  • Patients with known significant hepatic impairment at the discretion of the investigator.
  • Patients with clinically relevant abnormal ECG (if available) at the discretion of the investigator.
  • Patients with diagnosis of sickle cell disease.
  • Parents who do not speak one of Canada's two official languages (English or French)

Study Design

Enrollment

5 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Medication

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.

placebo comparator: Placebo

Participants on this arm receive placebo, masked and dispensed according to the same preset schedule as the Medication arm.

Interventions

Gabapentin

See arm descriptions

Placebo

See arm descriptions

Primary outcome measure

  • Mean pain and irritability score [ Time Frame: Days 11-19 ]

Central Contacts and Locations

Central contacts

Anne-Mette Hermansen, MA

604 875 2000ahermansen@bcchr.ca

Gail Andrews, RN

604 875 2000gandrews@cw.bc.ca

Locations

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

More Information

Sponsor

University of British Columbia

Last update posted

May 8, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-05-08.