Neuropathic pain
Conditions
Interventions
IMP test: Gabapentin oral solution (syrup). IMP comparator: Gabapentin placebo
oral solution
Gabapentin
Neuropathic pain
Paediatrics
Sponsors
Pharm SRL
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. 3 months-= 7/10 5. Stabel underlying disease condition and treatment 6. Patients with chemotherapy induced neuropathic pain: clinical remission or maintenance phase of treatment protocol
Exclusion criteria
Exclusion criteria: 1. Pain duration of more than 5 years 2. Current use of gabapentin or strong opoids 3. History of failure to respond to adequate treatment by gabapentin or opioids for neuropathic pain. 4. History of epileptic condition except febrile seizure disorder. 5. Subjects with diagnosis of sickle cell disease. 6. Subjects that present significant cognitive impairment. 7. Subjects that present current, controlled or uncontrolled, co-morbid psychiatric diagnosis that can impair pain diagnosis and assessment such as severe depressive conditions or psychosis. 8. Subjects with history of or current suicidal ideation or behaviour. 9. Subjects with a history of substance abuse in particular opoids 10. Subjects under prohibited concomitant medication (refer to specific protocol section 5.6.3.1 *Prohibited medications*). 11. Subjects in need for corticosteroid oral treatment or corticosteroid infiltrations to treat pain caused by infiltration or compression of neural structures, e.g. peripheral nerves or spinal cord. 12. Subjects old with a body mass index (BMI) for age and gender of 95th percentile (charts provided as Appendix 5). 13. Subjects with glomerular filtration rate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average pain score at the end of the treatment period (average of 2 measures each day for 3 days before end of study visit, V10) as assessed by age-appropriate pain scales (FLACC, FPS-R, NRS-11). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints a) Percentage of responders to treatments, defined as subjects with a 30% reduction from baseline in assessment scale (FLACC, FPS-R, NRS-11). b) Average daily pain intensity assessed by age appropriate scale during dose optimisation (FLACC, FPS-R or NRS-11). c) Observational assessment of pain using the NRS-11 completed by parents and Investigator (or caregiver) at each visit. d) Self-assessment of pain for children >8 years of age using the FPS-R pain scale at each visit. e) Number of episodes of breakthrough pain (> 4/10 pain score and use of rescue medications) during treatment period. f) Number of rescue interventions required during treatment period. g) Number of pain-free (6 years using the Retrospective-Modified Overt Aggression Scale (R-MOAS) at V2, V6 and EOS visit (V10). t) Suicidal ideation/behaviour in subjects aged 6 years and older using the Columbia - Suicide Severity Rating Scale (C-SSRS) scores before IMP (screening V1), V6 and at the EOS visit (V10). u) Assessment of blinding: guess of the subject*s treatment group (by Investigator, parents and subject if at adequate maturity level) at V10. Exploratory endpoints v) Metabolomic profile at screening (V1) and at EOS visit (V10), and in responders and non-responders. w) PK or PD outcomes based on genetic variation. | — |
Countries
Albania, Estonia, France, Germany, Greece, Italy, Netherlands
Outcome results
None listed