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CompletedNCT01506453TINALLUpdated Jun 19, 2019Results posted

Therapeutic Interventions For Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL)

A Phase 2 interventional study of gabapentin and placebo in Acute Lymphoblastic Leukemia, Neuropathy and Neuropathic Pain, sponsored by St. Jude Children's Research Hospital. Completed at 1 site in United States. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2019-06-19.

Sponsored by St. Jude Children's Research Hospital · Phase 2, Interventional, and Supportive care

Phase
Phase 2
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
1 Year to 18 Years
Sex
All
01

Study summary

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.

Read the detailed description

Patients with ALL on Total XVI ((or for those being treated "as per TOTXVI protocol") who experience NP/PN after specific doses of vincristine are eligible to enroll in the study as soon as the diagnosis of NP/PN related to VCR is established. The qualifying doses of vincristine have been selected because they fall in the schedule of weekly vincristine doses as per Total XVI, and 2 additional weekly vincristine doses are anticipated according to the protocol. Participants will be randomized to receive gabapentin or placebo upon enrollment. Morphine will be available to both groups as needed for pain at any time on the study. At the time of enrollment, and daily thereafter until completion of the study drug, data will be collected for pain assessment, and the daily dose of oral morphine used will be collected. Data regarding the pain type, quality, and location, as well as treatments used to manage pain will be assessed on a daily basis for the diagnostic event and for the period following the next two administrations of VCR treated with the study drug.

Primary Objective: To assess the analgesic efficacy of gabapentin in controlling VCR-related NP/PN in participants with ALL, by comparing the morphine daily dose (mg/kg/day) used to control NP/PN as a primary or a rescue regimen in the gabapentin vs. placebo groups.

Secondary Objective: To compare the pain scores in the gabapentin and placebo groups as recorded by pain score right now and pain score average for previous 24 hours.

02

Conditions studied

  • Acute Lymphoblastic Leukemia
  • Neuropathy
  • Neuropathic Pain

Keywords

  • Acute Lymphoblastic Leukemia
  • Neuropathy
  • Neuropathic Pain
  • Vincristine
  • TOTAL XVI Protocol
03

In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,121 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 492 are open to participants now.

This study's enrollment of 51 is above the median of 40 across 1,691 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

St. Jude Children's Research Hospital is the lead sponsor of 439 studies on the registry; 101 are open to participants now.

Of its 61 completed or terminated interventional studies of FDA-regulated products, 37 (61%) have results posted.

Browse St. Jude Children's Research Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant is enrolled on Total XVI or who are being treated "as per TOTXVI protocol"
  • Participant is 1 year of age or older
  • Participant has symptoms of NP/PN with onset no more than 7 days after one of the following vincristine doses ± 3 days: protocol week 1, week 2 (induction), week 7 (reinduction I), or week 17 (reinduction II).
  • Patient is expected to receive 2 doses of vincristine in weekly intervals as outlined by the Total XVI protocol (or for those being treated "as per TOTXVI" protocol) while on study drug (i.e. no known dosage reductions or planned missed doses).

Participant is able and willing to take oral medications.

Exclusion criteria

Exclusion Criteria:

  • Previous participation in this study
  • Participant is receiving gabapentin for another indication at the time of diagnosis of NP/PN or has received gabapentin previously.
  • Pregnancy. Female participants of childbearing potential must have documented negative urine or serum pregnancy test result not older than 7 days. Male patients with reproductive potential will be counseled not to procreate during the study.
  • Impaired renal function: decreased eGFR (\<60ml/min/1.73m\^2 as estimated by the revised Schwartz equation)
  • Participant has allergy or other contraindication for either morphine or gabapentin therapy.
  • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
51 participants (actual)

Study arms

  • Active comparator
    Gabapentin

    Active treatment arm.

    Drug: gabapentin

  • Placebo comparator
    Placebo

    Placebo arm.

    Drug: placebo

Interventions

  • Druggabapentin

    Participants randomized to the active treatment arm will receive gabapentin 20mg/kg/day PO divided into 3 doses and rounded to the nearest 100 mg for capsules and 10 mg for liquid preparation.

    Also known as: Treatment Arm

  • Drugplacebo

    Participants randomized to the placebo treatment arm will receive look-alike capsules or liquid in a respective capsule size or liquid measure equivalent to the active treatment arm, but which contain no active treatment.

    Also known as: Placebo Arm

06

What researchers measure

Primary outcomes

  1. Daily Total Dose of Oral Morphine (mg/kg/Day).

    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 Scale-Revised (FPS-R) Ages \>7 years, Self report using a numeric scale 0-10 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain. The scale information for the FLACC and FPS-R scales are similar.

    Time frame: Daily beginning day 1 for a maximum of 21 days.

Secondary outcomes

  1. Pain Scores Right Now

    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 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain.The scale information for the FLACC and FPS-R scales are similar.

    Time frame: Daily beginning day 1 through a maximum of 21 days.

  2. Pain Score During the Previous 24 Hours

    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 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain.The scale information for the FLACC and FPS-R scales are similar.

    Time frame: Daily beginning day 1 through a maximum of 21 days

07

Results

Posted Jun 19, 2019

Participant flow

51 participants were enrolled and screened between January 2012 and October 2016.

Participant flow — Overall Study
MilestoneGabapentinPlacebo
Started2526
Completed2524
Not completed02
Withdrew: Withdrawal prior to treatment02

Outcome measures

PrimaryDaily Total Dose of Oral Morphine (mg/kg/Day).

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 Scale-Revised (FPS-R) Ages \>7 years, Self report using a numeric scale 0-10 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain. The scale information for the FLACC and FPS-R scales are similar.

Time frame:
Daily beginning day 1 for a maximum of 21 days.
Reported as:
Mean · mg/kg/day
Daily Total Dose of Oral Morphine (mg/kg/Day).
mg/kg/dayGabapentinPlacebo
Day 10.38267 ± 0.289210.27433 ± 0.19299
Day 20.43685 ± 0.337880.31816 ± 0.16012
Day 30.37281 ± 0.329350.27961 ± 0.18509
Day 40.40384 ± 0.324690.35343 ± 0.18688
Day 50.37662 ± 0.312630.37920 ± 0.22471
Day 60.45679 ± 0.454500.43972 ± 0.19838
Day 70.50961 ± 0.436430.37181 ± 0.22883
Day 80.50767 ± 0.535700.38188 ± 0.28251
Day 90.49234 ± 0.333660.34524 ± 0.20164
Day 100.44392 ± 0.372440.34660 ± 0.15843
Day 110.50981 ± 0.675160.29937 ± 0.14111
Day 120.57798 ± 0.513460.40090 ± 0.21956
Day 130.68183 ± 0.516980.45933 ± 0.32854
Day 140.53028 ± 0.578700.34957 ± 0.15460
Day 150.55939 ± 0.697550.36731 ± 0.23170
Day 160.37643 ± 0.378170.48481 ± 0.37075
Day 170.38837 ± 0.301900.54960 ± 0.47579
Day 180.65013 ± 0.966030.13605 ± NA
Day 190.84586 ± 1.086560.14123 ± 0.00740
Day 201.12358 ± 1.377900.15108 ± NA
Day 210.14981 ± NA—
SecondaryPain Scores Right Now

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 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain.The scale information for the FLACC and FPS-R scales are similar.

Time frame:
Daily beginning day 1 through a maximum of 21 days.
Reported as:
Mean · score on a scale 0-10
Pain Scores Right Now
score on a scale 0-10GabapentinPlacebo
Day 11.64000 ± 1.890331.69565 ± 2.09837
Day 22.00000 ± 2.198481.16667 ± 1.57885
Day 31.88000 ± 2.603200.75000 ± 1.25974
Day 41.92000 ± 2.644490.83333 ± 1.30773
Day 51.64000 ± 1.976531.00000 ± 1.44463
Day 61.40000 ± 1.755940.79167 ± 1.38247
Day 72.20000 ± 2.179450.91667 ± 1.50121
Day 81.32000 ± 1.908750.56522 ± 1.23679
Day 91.48000 ± 2.063980.86957 ± 1.63219
Day 101.16000 ± 1.650250.39130 ± 0.83878
Day 111.16000 ± 1.907880.82609 ± 1.26678
Day 121.21739 ± 1.881891.00000 ± 1.50756
Day 131.04348 ± 1.460950.69565 ± 1.39593
Day 140.82609 ± 1.114050.52174 ± 1.23838
Day 150.90909 ± 1.630340.60870 ± 1.23359
Day 161.29412 ± 1.992630.31250 ± 0.87321
Day 170.40000 ± 0.910260.21429 ± 0.80178
Day 181.45455 ± 2.544160.25000 ± 0.86603
Day 191.00000 ± 1.414210 ± 0
Day 201.33333 ± 1.154700 ± 0
Day 21—0 ± 0
SecondaryPain Score During the Previous 24 Hours

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 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain.The scale information for the FLACC and FPS-R scales are similar.

Time frame:
Daily beginning day 1 through a maximum of 21 days
Reported as:
Mean · score on a scale 0-10
Pain Score During the Previous 24 Hours
score on a scale 0-10GabapentinPlacebo
Day 13.48000 ± 2.502003.41667 ± 2.39414
Day 23.16000 ± 2.374872.20833 ± 2.14637
Day 33.08000 ± 2.289831.87500 ± 1.87228
Day 42.80000 ± 2.432422.12500 ± 2.64267
Day 52.80000 ± 2.614062.00000 ± 2.14679
Day 62.28000 ± 1.926141.91667 ± 2.20507
Day 72.96000 ± 2.226361.16667 ± 1.60615
Day 82.76000 ± 2.241281.69565 ± 1.91726
Day 92.16000 ± 2.211331.34783 ± 1.74795
Day 102.16000 ± 2.248701.43478 ± 1.64665
Day 112.32000 ± 2.055891.56522 ± 1.67403
Day 122.41667 ± 2.430181.52174 ± 1.90381
Day 132.50000 ± 2.206711.60870 ± 1.85225
Day 142.60870 ± 2.271151.56522 ± 1.64665
Day 152.54545 ± 2.154231.39130 ± 1.67167
Day 162.23529 ± 1.821041.56250 ± 1.82460
Day 171.40000 ± 1.594631.92857 ± 2.01778
Day 182.36364 ± 3.009081.00000 ± 1.65145
Day 191.40000 ± 1.341640.40000 ± 0.89443
Day 202.33333 ± 0.577350 ± 0
Day 21—0 ± 0

Adverse events

Collected over through study completion, up to 21 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Gabapentin0/25 (0%)0/25 (0%)5/25 (20%)
Placebo0/24 (0%)0/24 (0%)5/24 (20.8%)
Most frequent other events
Most frequent other events
EventGabapentinPlacebo
Depressed level of consciousnessNervous system disorders5/255/24
AnxietyPsychiatric disorders1/250/24

Baseline characteristics

Age, Continuous
Age, Continuous(years)GabapentinPlaceboTotal
Mean7.88 ± 5.697.08 ± 3.907.48 ± 4.83
Sex: Female, Male
Sex: Female, Male(Participants)GabapentinPlaceboTotal
Female111021
Male141630
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)GabapentinPlaceboTotal
Baseline Measures — Asian and White011
Baseline Measures — Black123
Baseline Measures — Black and White123
Baseline Measures — White232144
Region of Enrollment
Region of Enrollment(Participants)GabapentinPlaceboTotal
United States252651
Daily "pain score right now"
Daily "pain score right now"(units on a scale)GabapentinPlaceboTotal
Mean3.12 ± 1.863.58 ± 1.423.35 ± 1.65
baseline pain score last 24 hours
baseline pain score last 24 hours(units on a scale)GabapentinPlaceboTotal
Mean4.08 ± 1.664.31 ± 1.764.20 ± 1.70
08

Study locations

1 site
  • St. Jude Children's Research Hospital
    Memphis, Tennessee 38105, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 24, 2016

Documents are hosted by the registry — open the source record to download them.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2012 to primary completion in Jan 2018, 71 months.

Results were first posted in Jun 2019, 1 year 5 months after primary completion.

Of 208 non-industry phase 2 interventional studies under Precursor Cell Lymphoblastic Leukemia-Lymphoma, half reached primary completion within 80 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 120. This study's 71 months is below that.

Counting every sponsor, half of 229 studies reached it within 73 months; a quarter within 43 and three quarters within 111.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 4, 2012
First posted
Jan 10, 2012
StartActual
Jan 24, 2012
Primary completionActual
Jan 2, 2018
CompletionActual
Jan 2, 2018
Results first posted
Jun 19, 2019
Last update
Jun 19, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01506453
Lead sponsor
St. Jude Children's Research Hospital
Responsible party
Sponsor
First posted
Jan 10, 2012
Start date
Jan 24, 2012
Primary completion
Jan 2, 2018
Completion
Jan 2, 2018
Results posted
Jun 19, 2019
Last update
Jun 19, 2019

Study contacts

Doralina Anghelescu, MD
principal investigator · St. Jude Children's Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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