Clinical trial · Interventional
Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for ALL
Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for Acute Lymphocytic Leukemia
NCT00299234CI-TRIAL-00006792terminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient number of interested potentital subjects
Summary
Brief summary (as posted)
This study is a double-blind, placebo-controlled, parallel group trial of atomoxetine (1.8 mg/kg) for the management of chemotherapy-related acquired attentional disorders in children who have survived Acute Lymphocytic Leukemia. Atomoxetine will produce a favorable impact on ADHD symptoms in children with chemo-related acquired attentional disorders.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Attention Deficit Hyperactivity Disorder | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atomoxetine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- placebo
- interventionNames
- Drug: Atomoxetine
- type
- EXPERIMENTAL
- label
- 1
- description
- atomoxetine
- interventionNames
- Drug: Atomoxetine
Primary outcomes (1)
- measure
- The primary outcome is the change in the ADHD-RS total score from baseline to completion of the study.
- timeFrame
- 5 weeks
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ages 6-18 years * Must have successfully completed treatment for ALL and are currently 1-year "disease free" as judged by the investigators. * Must meet DSM-IV criteria for "ADHD-NOS.( Attachment A) The attention deficit symptoms have been precipitated by chemotherapy-related neurological injury. Therefore, the DSM-IV category is ADHD-NOS. * Must have an Investigator-completed ADHD-RS total and/or subscale score of ≥1.5 standard deviations above age/gender norm. * Laboratory results, including chemistries, hematology, and urinalysis do not demonstrate clinically significant abnormalities. * ECG demonstrates no clinically significant abnormalities * Educational level and degree of understanding of the patient and their parents permit suitable communication between the investigators and study coordinators. * Subjects and parents are judged to be reliable to keep appointments. * Must be able to swallow tablets. * Must have demonstrated compliance during their chemotherapy program. * Must weigh \> 20 kg. Exclusion Criteria: * Have relapsed or are having re-occurring symptoms/signs of ALL. * Have had substantial exposure to radiation therapy (\>2000: cGy) since high dose radiation treatment is associated with neurocognitive deficits or be "treatment resistant" pharmacologically. * Past exposure to atomoxetine. * ADHD symptoms or treatment prior to the diagnosis of ALL * Documented bipolar disorder, psychosis, affective disorder. * Female subjects who are pregnant or breastfeeding. * Suicide risk. * Seizure disorders (except history of febrile seizures). * Histories of multiple drug allergies. * Histories of alcohol or substance abuse. * Prior or current medical conditions that, in the opinion of the investigators, could be exacerbated by atomoxetine. * Sympathomimetic overactivity such as catecholamine secreting tumor. * Use of MAOI medications. * Have taken psychostimulants one week prior to randomization. * Current or past history of hypertension.
References
Publications (3)
- BACKGROUNDMulhern RK, Friedman AG, Stone PA. Acute lymphoblastic leukemia: long-term psychological outcome. Biomed Pharmacother. 1988;42(4):243-6. PMID 3056531
- BACKGROUNDSchuler D, Bakos M, Borsi J, Gacsaly I, Kalmanchey R, Kardos G, Koos R, Nagy C, Revesz T, Somlo P, et al. Neuropsychologic and CT examinations in leukemic patients surviving 10 or more years. Med Pediatr Oncol. 1990;18(2):123-5. doi: 10.1002/mpo.2950180207. PMID 2304419
- BACKGROUNDGoff JR, Anderson HR Jr, Cooper PF. Distractibility and memory deficits in long-term survivors of acute lymphoblastic leukemia. J Dev Behav Pediatr. 1980 Dec;1(4):158-63. PMID 6941969