Clinical Trial Details
Return to Clinical Trials Home| Actively Enrolling | Yes |
| Primary Investigator | Dunn,David |
| Title | A Long-Term, Open-Label Safety Study of LY2216684 in Pediatric Patients with Attention Deficit/Hyperactivity Disorder |
| Date Published | January 12th, 2010 |
| Contact Name | Pediatric Research |
| Contact Phone | 317-274-8785 |
| Compensation | Yes |
| Disease | (LY2216684) in Attention-Deficit/Hyperactivity Disorder (ADHD) |
| Healthy Volunteers | No |
| Inclusion / Exclusion | Inclusion criteria:
For the patients who have participated in and completed a previous LY2216684 study ("rollover patients"), the first 3 inclusion criteria must be met at the time of entry into their first LY2216684 study. For the patients who have never par...Inclusion criteria: For the patients who have participated in and completed a previous LY2216684 study ("rollover patients"), the first 3 inclusion criteria must be met at the time of entry into their first LY2216684 study. For the patients who have never participated in a previous LY2216684 study ("new patients"), the first 3 Inclusion criteria must be met at Visit 1 and/or Visit 2 of this study. 1. Patients must be at least 12 years and less than 18 years of age at the time the informed consent is signed for this trial for new patients. Patients who rollover from the previous pediatric LY2216684 studies must have met the age requirement of the parent trials at that enrollment. 2. Patients must meet DSM-IV diagnostic criteria for ADHD (inattentive, hyperactive/impulsive, or combined subtypes) based on an interview by an experienced clinician and confirmed using the K-SADS-PL at Visit 1 for new patients and in the parent trial for rollover patients. 3. Patients must have an ADHDRS-IV-Parent: Inv total score of at least 1.5 standard deviations above the age and gender norm at both Visit 1 and Visit 2 for new patients and in the parent trial for rollover patients. In addition, new patients must have a CGI-ADHD-S score ≥ 4 at both Visit 1 and Visit 2. 4. Male patients and female patients of child-bearing potential agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug. Additionally, female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a urine pregnancy test. 5. Patients must have laboratory results, including serum chemistries, hematology, and urinalysis, showing no clinically significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation) or that, in the judgment of the physician, should preclude a patient’s participation at study entry. 6. Parents and/or patients must have a degree of understanding sufficient to communicate suitably with the investigator and study coordinator. 7. Patients must be of normal intelligence, per the clinical judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit (specific learning disorders would not be considered to be general intellectual deficits) and expectation of achievement of a score of 80 or more if formal IQ testing were administered. 8. Patients and parents must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipunctures and examinations required by the protocol. 9. Patients must be able to swallow tablets (study drug). Exclusion criteria 1. Patients who weigh less than 16 kg at Visit 1 and Visit 2. 2. Female patients who are pregnant or who are breast-feeding. 3. Patients who have previously withdrawn or discontinued early from this study or any other study investigating LY2216684. 4. Patients who have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder. 5. Patients with a history of any seizure disorder (other than febrile seizures) or known electroencephalographic (EEG) abnormalities in the absence of seizures. 6. If the ECG assessed at Visit 1 shows an abnormality meeting 1 or more of the absolute Exclusion criteria listed in the Pediatric ECG Alert Criteria, the patient must be excluded from the study. For patients with other Alert Criteria, the investigator must consult with the Lilly research physician. 7. Patients who, in the opinion of the investigator, are at serious suicidal risk. 8. Patients with a history of severe allergies to more than 1 class of medications, or multiple adverse drug reactions, or known hypersensitivity to LY2216684. 9. Patients with a history of alcohol or drug abuse/dependence within the past 3 months of Visit 1 (excessive or compulsive use as judged by the investigator), or who are currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner that the investigator considers indicative of abuse/dependence. 10. Patients who screen positive for drugs of abuse cannot participate. Drug screen may be repeated once at the discretion of the investigator, and the patient may be allowed to enter the study if the repeat screen is negative. All patients must have a negative drug screen before enrollment in the study. 11. Patients who have a medical condition that would increase sympathetic nervous system activity markedly (for example, catecholamine-secreting neural tumor), or who are taking a medication on a daily basis (for example, albuterol, pseudoephedrine) that has sympathomimetic activity are excluded. Such medications can be taken on an as needed basis. 12. Patients with problems that would be exacerbated by increased norepinephrine tone including a history of cardiovascular disease (overt or hidden), thyroid dysfunction, glaucoma, or urinary retention. 13. Patients who at any time during the study are likely to need psychotropic medications apart from the drugs under study. 14. Patients who have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks (14 days) prior to Visit 2. 15. Patients with current or past history of clinically significant hypertension. Hypertension will be defined as average systolic or diastolic blood pressure measured on at least 2 occasions, greater than or equal to the 95th percentile for age and sex defined from standards of the National Heart, Lung, and Blood Institute (National High Blood Pressure Education Program Working Group on Hypertension Control in Children and Adolescents [2004]). Patients whose blood pressure is under control by antihypertensives at a stable dose for a minimum of 3 months prior to Visit 1 are allowed after consulting with Lilly research physician. 16. Patients who are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug (other than this study drug), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. 17. Patients whose family anticipates a move outside the geographic range of the investigative site during participation in the study or who plan extended travel inconsistent with the recommended visit intervals. 18. Investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. 19. Patients who, in the opinion of the investigator, are unsuitable in any other way to participate in this study. 20. Patients who are employed by Lilly (that is, employees, temporary contract workers, or designees responsible for conducting the study). Immediate family of Lilly employees may participate in Lilly sponsored clinical trials, but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. More |