NCT00299234TerminatedPhase 4
Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for Acute Lymphocytic Leukemia
Monarch Medical Research1 site in 1 country1 target enrollmentStarted: June 2006Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- The primary outcome is the change in the ADHD-RS total score from baseline to completion of the study.
Study Overview
Brief Summary
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.
Detailed Description
The primary objective of this study is to assess the safety, tolerability and efficacy of atomoxetine as determined by the change in the ADHD-RS-IV Total score compared to placebo in the symptomatic treatment of patients diagnosed with Attention-Deficit/Hyperactivity Disorder (by DSM-IV ADHD-NOS criteria) occurring as a neuropsychological late-effect of chemotherapy used to treat Acute Lymphocytic Leukemia (ALL).
The secondary objectives are:
- to assess the effect of once daily (AM) dosing of atomoxetine (1.8mg/kg) compared to placebo on ADHD symptoms as measured by:
- ADHD-RS Total score inclusive of subtypes for inattention, hyperactivity and combined subtypes.
- Clinical Global Impression-ADHD
- to evaluate the safety and tolerability of atomoxetine compared with placebo based on treatment-emergent adverse events (AEs), laboratory tests, vital signs, physical examinations, and ECGs.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
2
Placebo Comparator
placebo
Intervention: Atomoxetine (Drug)
1
Experimental
atomoxetine
Intervention: Atomoxetine (Drug)
Outcomes
Primary Outcomes
The primary outcome is the change in the ADHD-RS total score from baseline to completion of the study.
Time Frame: 5 weeks
Secondary Outcomes
- The secondary outcome is the difference in CGI categories by the treatment versus placebo group.(5 weeks)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 4
Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid DyslexiaDyslexiaAttention Deficit Hyperactivity DisorderNCT00607919Eli Lilly and Company209
Completed
Phase 4
Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) With Atomoxetine in Young Adults and Its Effects on Functional OutcomesAttention Deficit Hyperactivity DisorderNCT00510276Eli Lilly and Company445
Completed
Phase 4
Atomoxetine Versus Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents With Autism Spectrum DisorderAutistic DisorderAttention Deficit Disorder With HyperactivityNCT00380692Eli Lilly and Company97
Completed
Phase 3
Effectiveness of Atomoxetine in Treating ADHD Symptoms in Children and Adolescents With AutismAutismNCT00498173Massachusetts General Hospital60
Completed
Phase 4
Placebo-Controlled Study of Atomoxetine Hydrochloride in the Treatment of Adults With ADHD and Comorbid Social Anxiety DisorderComorbid Social Anxiety DisorderAttention Deficit Hyperactivity DisorderNCT00190879Eli Lilly and Company440