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NCT01506453 · ClinicalTrials.gov registry record · Phase 2
Therapeutic Interventions For Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL)
A Phase 2 study of Acute Lymphoblastic Leukemia and Neuropathic Pain, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT01506453: Completed Phase 2 study of Acute Lymphoblastic Leukemia and Neuropathic Pain, sponsored by St. Jude Children's Research Hospital.
NCT01506453 is a Phase 2 study of Acute Lymphoblastic Leukemia and Neuropathic Pain that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 51 participants, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01506453, a Phase 2 study of Acute Lymphoblastic Leukemia and Neuropathic Pain, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG placebo
- DRUG gabapentin
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2012-01-24 |
| Est. Completion | 2018-01-02 |
| Phase | Phase 2 |
What the finished NCT01506453 record still lists
NCT01506453 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (87% lower).
The record links to 3 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01506453 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT01506453 about?
NCT01506453 is a clinical study titled "Therapeutic Interventions For Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL)". 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 va...
What is the current status of trial NCT01506453?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2012-01-24. Estimated completion is 2018-01-02.
What conditions does trial NCT01506453 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Neuropathic Pain, Neuropathy.
What interventions are being tested in trial NCT01506453?
The interventions under investigation include: placebo (DRUG), gabapentin (DRUG).
Who is sponsoring clinical trial NCT01506453?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01506453 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01506453's enrollment target sits among peer trials
51 72nd of 131 higher than 60 of 131 other Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Lymphoblastic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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