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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Male or female, aged 3 months to less than 18 years at screening (V1)
2. Informed consent by parent(s) and/or legal guardian according to each country legal
requirement.
3. Assent, where applicable, according to each country legal requirement.Informed (co-)
consent of child, where applicable, according to each country legal requirement.
4. Subjects that meet the diagnostic criteria for neuropathic or mixed pain.
5. Subjects that present with chronic pain defined as the recurrent or continuous pain
persisting more than 3 months.
6. Subject that present with severe pain as defined by average pain intensity of =7 /10
as assessed during a 3-day screening period
7. Stable underlying disease condition and treatment.
8. Patients with Chemotherapy Induced Peripheral Neuropathy, when in clinical remission
or maintenance phase of their therapeutic protocol.
Exclusion Criteria:
1. Pain duration of more than 5 years.
2. Current use of gabapentin.
3. Current use of strong opioids (morphine, methadone, fentanyl, ketamine, oxycodone).
4. History of failure to respond to adequate treatment by gabapentin or opioids for
neuropathic pain.
5. History of epileptic condition (except febrile seizure disorder).
6. Subjects with diagnosis of sickle cell disease.
7. Subjects that present significant cognitive impairment.
8. 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.
9. Subjects with history of or current suicidal ideation or behaviour.
10. Subjects with history of substance abuse in particular opioids.
11. Subjects under prohibited concomitant medication .
12. Subjects with a body mass index (BMI) for age and gender of < 5th percentile or > 95th
percentile (charts provided as Appendix 3).
13. Subjects with significant renal impairment, i.e., glomerular filtration rate < 90
mL/min/1.73 m2 (Revised Schwarz equation).
14. Subjects with significant hepatic impairment or with Aspartate Transaminase (AST) or
Alanine Transaminase (ALT) enzymes 3 times the upper limit of the age-specific
reference range.
15. 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.
16. Subjects with clinically relevant abnormal ECG at the screening visit in the
discretion of the Investigator/cardiologist.
17. Subjects with known allergy, hypersensibility or clinically significant intolerance to
gabapentin or any component found in the study drugs.
18. Subjects with fructose intolerance, diabetes, glucose-galactose malabsorption or
lactase-isomaltase deficiency.
19. Subjects participating in another clinical interventional trial.
20. Subjects scheduled for surgery or in recovery from surgery occurring within 3 months
of baseline assessment.
21. Female subjects who are pregnant or currently lactating.
22. Subjects that failed screening or were previously enrolled in this study
23. Patients with Chemotherapy Induced Peripheral Neuropathy, when in induction phase of
their therapeutic protocol
Age minimum:
3 Months
Age maximum:
17 Years
Gender:
All
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Secondary Outcome(s)
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Extent of pain
[Time Frame: on average of 16 weeks]
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Clinical Global Impression of Improvement for pain
[Time Frame: an average of 15 weeks]
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Percentage of subjects discontinuing the Trial
[Time Frame: up to 21 weeks]
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Number of pain-free days
[Time Frame: on average of 15 weeks]
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Participant dropouts
[Time Frame: up to 21 weeks]
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Tmax
[Time Frame: at week 3 or at week 4 or at week 16]
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Vd/F
[Time Frame: at week 3 or at week 4 or at week 16]
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Assessment of blinding
[Time Frame: at week 16]
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Clinical Global Impression of Severity of the subject's condition
[Time Frame: an average of 15 weeks]
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Daily pain intensity
[Time Frame: an average of 3 weeks]
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Incidence of Adverse Events
[Time Frame: up to 21 weeks]
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Global satisfaction with treatment
[Time Frame: at week 16]
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Percentage of responders to treatments
[Time Frame: on average of 16 weeks]
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Patient/parent Global Impression of Change
[Time Frame: an average of 12 weeks]
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Self-assessment of pain for children =8 years of age
[Time Frame: on average of 16 weeks]
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Psychosocial Health Summary Score from PedsQL™ scale
[Time Frame: on average of 15 weeks]
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Aggressive behaviour in children aged >6 years
[Time Frame: an average of 15 weeks]
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Cmax
[Time Frame: at week 3 or at week 4 or at week 16]
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Cmin
[Time Frame: at week 3 or at week 4 or at week 16]
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Css
[Time Frame: at week 3 or at week 4 or at week 16]
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Number of episodes of breakthrough pain
[Time Frame: on average of 15 weeks]
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Number of rescue interventions required during treatment period
[Time Frame: on average of 15 weeks]
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Systemic exposure to investigational product
[Time Frame: an average of 12 weeks]
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AUC
[Time Frame: at week 3 or at week 4 or at week 16]
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CL/F
[Time Frame: at week 3 or at week 4 or at week 16]
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ka
[Time Frame: at week 3 or at week 4 or at week 16]
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Observational assessment of pain
[Time Frame: on average of 16 weeks]
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The total cumulative weight normalized dose of each rescue drug.
[Time Frame: on average of 16 weeks]
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Total Summary Score from PedsQL™ scale
[Time Frame: on average of 15 weeks]
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Acceptability of treatment
[Time Frame: at week 16]
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Physical Health Summary Score from PedsQL™ scale
[Time Frame: on average of 15 weeks]
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Suicidal ideation/behaviour in subjects aged 6 years and older
[Time Frame: an average of 16 weeks]
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