Adults 1 to 18, any sex, with Acute Lymphoblastic Leukemia or Neuropathy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Daily Total Dose of Oral Morphine (mg/kg/Day).Primary· Daily beginning day 1 for a maximum of 21 days.
The response to therapy will be measured by pain intensity scores and daily use of morphine doses for breakthrough pain as described in the study objectives. Daily assessments will continue during treatment with the study drug (gabapentin or placebo) irrespective of patient response to study treatment. and toddlers (less than age 4 years) or other children who cannot self report, use the FLACC Scale Score each component as a subscore (face, legs, activity, cry, consolability) Total subscores to determine FLACC score Older children (ages 4 to 7 years) who can self-report, use the Faces Pain Sca
Day 1
Group
Value
95% CI
Gabapentin
0.38267
± 0.28921
Placebo
0.27433
± 0.19299
Day 2
Group
Value
95% CI
Gabapentin
0.43685
± 0.33788
Placebo
0.31816
± 0.16012
Day 3
Group
Value
95% CI
Gabapentin
0.37281
± 0.32935
Placebo
0.27961
± 0.18509
Day 4
Group
Value
95% CI
Gabapentin
0.40384
± 0.32469
Placebo
0.35343
± 0.18688
Day 5
Group
Value
95% CI
Gabapentin
0.37662
± 0.31263
Placebo
0.37920
± 0.22471
Day 6
Group
Value
95% CI
Gabapentin
0.45679
± 0.45450
Placebo
0.43972
± 0.19838
Day 7
Group
Value
95% CI
Gabapentin
0.50961
± 0.43643
Placebo
0.37181
± 0.22883
Day 8
Group
Value
95% CI
Gabapentin
0.50767
± 0.53570
Placebo
0.38188
± 0.28251
Pain Scores Right NowSecondary· Daily beginning day 1 through a maximum of 21 days.
A score ranging from 0 to 10, measured by age appropriate validated pain scale. Because there was only one patient during day 21 time point for this treatment group, the mean and standard deviation could not be calculated. Infants and toddlers (less than age 4 years) or other children who cannot self report, use the FLACC Scale Score each component as a subscore (face, legs, activity, cry, consolability) Total subscores to determine FLACC score Older children (ages 4 to 7 years) who can self-report, use the Faces Pain Scale-Revised (FPS-R) Ages \>7 years, Self report using a numeric scale 0-10
Day 1
Group
Value
95% CI
Gabapentin
1.64000
± 1.89033
Placebo
1.69565
± 2.09837
Day 2
Group
Value
95% CI
Gabapentin
2.00000
± 2.19848
Placebo
1.16667
± 1.57885
Day 3
Group
Value
95% CI
Gabapentin
1.88000
± 2.60320
Placebo
0.75000
± 1.25974
Day 4
Group
Value
95% CI
Gabapentin
1.92000
± 2.64449
Placebo
0.83333
± 1.30773
Day 5
Group
Value
95% CI
Gabapentin
1.64000
± 1.97653
Placebo
1.00000
± 1.44463
Day 6
Group
Value
95% CI
Gabapentin
1.40000
± 1.75594
Placebo
0.79167
± 1.38247
Day 7
Group
Value
95% CI
Gabapentin
2.20000
± 2.17945
Placebo
0.91667
± 1.50121
Day 8
Group
Value
95% CI
Gabapentin
1.32000
± 1.90875
Placebo
0.56522
± 1.23679
Pain Score During the Previous 24 HoursSecondary· Daily beginning day 1 through a maximum of 21 days
A score ranging from 0 to 10, measured by age appropriate validated pain scale. Because there was only one patient during day 21 time point for this treatment group, the mean and standard deviation could not be calculated.Infants and toddlers (less than age 4 years) or other children who cannot self report, use the FLACC Scale Score each component as a subscore (face, legs, activity, cry, consolability) Total subscores to determine FLACC score Older children (ages 4 to 7 years) who can self-report, use the Faces Pain Scale-Revised (FPS-R) Ages \>7 years, Self report using a numeric scale 0-10
Day 1
Group
Value
95% CI
Gabapentin
3.48000
± 2.50200
Placebo
3.41667
± 2.39414
Day 2
Group
Value
95% CI
Gabapentin
3.16000
± 2.37487
Placebo
2.20833
± 2.14637
Day 3
Group
Value
95% CI
Gabapentin
3.08000
± 2.28983
Placebo
1.87500
± 1.87228
Day 4
Group
Value
95% CI
Gabapentin
2.80000
± 2.43242
Placebo
2.12500
± 2.64267
Day 5
Group
Value
95% CI
Gabapentin
2.80000
± 2.61406
Placebo
2.00000
± 2.14679
Day 6
Group
Value
95% CI
Gabapentin
2.28000
± 1.92614
Placebo
1.91667
± 2.20507
Day 7
Group
Value
95% CI
Gabapentin
2.96000
± 2.22636
Placebo
1.16667
± 1.60615
Day 8
Group
Value
95% CI
Gabapentin
2.76000
± 2.24128
Placebo
1.69565
± 1.91726
Adverse events — posted to ClinicalTrials.gov
Time frame: through study completion, up to 21 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Neuropathic pain / peripheral neuropathy (NP/PN) is a known painful complication of vincristine (VCR) therapy; evidence supporting the best treatment plan for pediatric patients is limited. Gabapentin is frequently used for VCR-related NP/PN, with variable dosing and scheduling regimens, and with varying measures of success. The hypothesis of the study is that gabapentin will reduce the severity of NP/PN in patients receiving vincristine during treatment for ALL on the Total XVI protocol (or for those being treated "as per TOTXVI protocol"), as measured by two outcome measures: the daily dose of morphine used as needed for pain in addition to either gabapentin or placebo, as randomized, and the pain scores assessed daily.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by St. Jude Children's Research Hospital
Last refreshed: 19 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01506453.