Table 11.

Summary of Naltrexone (NTX) Efficacy and Safety in Pediatric Trials in Prader-Willi syndrome, Crohns Disease, and Complex Regional Pain Syndrome

Reference	Sample Size (Study Design)	Disease – Dosing and Duration	Outcome
Banga191	1 (case report)	Prader-Willi syndrome in a 15-yr-old male – NTX: 50 mg/day for 15 mo	Cessation of skin-picking. Resumption of behavior when NTX stopped and ceased again when NTX was restarted. SAE: none
Benjamin192	1 (case report)	Prader-Willi syndrome in a 9-yr-old male – NTX: up to 50 mg/day	Reduced food-seeking behavior and skin-picking. Resumption of behaviors occurred when NTX stopped and reduced again when restarted. SAE: none
Puri193	1 (case report)	Prader-Willi syndrome in a 13-yr-old female – NTX/bupropion: 32 mg/360 mg per day for 6 wk	Weight: 4% loss Aggression and eating habits: reduced BMI: baseline: 33.9; NTX: 32.7 SAE: none
Zlotkin194	4 (PCT)	Prader-Willi syndrome in a 13 to 17-yr–old obese – NTX: 50 mg twice daily for 7 days	Weight: 1.05-kg gain (CV = 65%) No change in attentiveness, alertness, mood, or nutrient intake. SAE: none
Smith195	14 (R, PCT)	Crohns Disease in 8- to 17-yr–old with– NTX: 0.1 mg/kg (max 4.5 mg/day) for 8 wk	PCDAI: baseline: 34.2; NTX: 21.7 (CV = 15) Remission: 25% achieved; improved: 67% SAE: none
Chopra196	1 (case report)	Complex regional pain syndrome in a 12-yr-old – NTX: up to 4.5 mg/day for 18 mo	Pain scores: baseline: 7–10/10 (baseline); NTX: 3–5/10 SAE: none

BMI, body mass index; CV, coefficient of variation; PCDAI, Pediatric Crohn's Disease Activity Index;; PCT, placebo-controlled trial; PLB, placebo; R, randomized; SAE, serious adverse event