Attention Deficit Hyperactivity DisorderPhase 4NCT00299234
Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for ALL
A Phase 4 study testing Atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by Monarch Medical Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Atomoxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Monarch Medical Research - Child and Adolescent Neurology
Norfolk, Virginia, 23510
About this study
Official title: Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for Acute Lymphocytic Leukemia
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.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Atomoxetine
- Keywords
- Attention Deficit Hyperactivity Disorder
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtomoxetineDrug
titration schedule: 0.5 to 1.5 mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | placebo Receives: Drug: Atomoxetine |
| 1 | Experimental | atomoxetine Receives: Drug: Atomoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the change in the ADHD-RS total score from baseline to completion of the study.
Measured: 5 weeks
Secondary outcomes (1)
The secondary outcome is the difference in CGI categories by the treatment versus placebo group.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: Insufficient number of interested potentital subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monarch Medical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Investigators
- Donald W Lewis, MD, Principal investigator, Monarch Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299234
- Sponsor's protocol ID
- B4Z-MC-X040
- Status last verified
- Apr 2007
- First submitted
- 2 Mar 2006
- Last updated
- 26 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Mulhern RK, Friedman AG, Stone PA. Acute lymphoblastic leukemia: long-term psychological outcome. Biomed Pharmacother. 1988;42(4):243-6.
PubMed 3056531Schuler 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.
PubMed 2304419Goff 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.
PubMed 6941969
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for Acute Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00299234
- Acronym / sponsor ID
- B4Z-MC-X040
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient number of interested potentital subjects
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Monarch Medical ResearchUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Jun 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: Atomoxetineplacebo |
| 1 | Experimental | Drug: Atomoxetineatomoxetine |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atomoxetinetitration schedule: 0.5 to 1.5 mg/kg/day | Drug | 1, 2 |
Primary outcome
The primary outcome is the change in the ADHD-RS total score from baseline to completion of the study.
Time frame: 5 weeks
1 secondary outcome
The secondary outcome is the difference in CGI categories by the treatment versus placebo group.
Time frame: 5 weeks
Results and safety
The study was stopped early (reason given: Insufficient number of interested potentital subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2012.
- Background: PubMed 3056531Mulhern RK, Friedman AG, Stone PA. Acute lymphoblastic leukemia: long-term psychological outcome. Biomed Pharmacother. 1988;42(4):243-6.
- Background: PubMed 2304419Schuler 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.
- Background: PubMed 6941969Goff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald W Lewis, MD principal investigator
Monarch Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by Monarch Medical Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient number of interested potentital subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the change in the ADHD-RS total score from baseline to completion of the study. (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00299234, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2012.