Evaluate the Safety and Efficacy of Modafinil in Children and Adolescents With ADHD
This study has been completed.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
First received: September 14, 2005
Last updated: July 25, 2012
Last verified: July 2012
Primary objective of this study is to evaluate the safety of treatment with modafinil film-coated tablet.
Attention Deficit/Hyperactivity Disorder
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A 1-Year, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Continued Efficacy of Modafinil (Film-coated Tablet Formulation) in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (Followed by an Open-Ended Extension Period)
Primary Outcome Measures:
- Evaluate the safety of treatment with the modafinil film coated tablet.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2006 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||6 Years to 17 Years (Child)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
Inclusion Criteria: Patients are included in the study if they participated in a previous qualifying study with modafinil and, in the opinion of the investigator, will continue to benefit from treatment with modafinil. In addition, the following criteria must be met:
- a boy or girl 6 to 17 years of age, inclusive, and English-speaking
- weight and height between the 5th and 95th percentile on the National Center for Health Statistics (NCHS) growth chart for age, height, and weight
- if more than 6 months since last dose of study drug, meets the full DSM-IV crieria for ADHD (combined typd, predominantly inattentive type, or predominantly hyperactive - impulsive type) at screening, as manifested by a psychiatric/clinical evaluation and confirmed by a structured diagnostic interview, namely, the Diagnostic Interview Schedule for Children, Fourth Edition (DISC-IV).
- are in good health (except for a diagnosis of ADHD) as determined by medical and psychiatric history, physical examination, ECG, serum chemistry, hematology, urinalysis
- girls of child bearing potential (Tanner scale >3) OR all girls 8 years of age and older have a negative urine pregnancy test at screening, must be using a medically acceptable method of birth control, and must agree to continue use of this method for the duration of the study (and for 30 days after participation in the study). (NOTE: For conducting pregnancy tests, the investigator has the option of determining the sexual maturity all girls 8 years of age and older.) Acceptable methods of birth control include: barrier method with spermicide; steroidal contraceptive (eg, oral, transdermal, implanted, and injected) in conjunction with a barrier method; intrauterine device (IUD); or abstinence
- have a parent or legal guardian who is willing to participate in the study.
Exclusion Criteria: Patients are excluded from participating in this study if 1 or more of the following criteria are met:
- a history or current diagnosis of pervasive developmental disorder, schizophrenia, or other psychotic disorders, or a clinical assessment of current suicide risk
- any current psychiatric comorbidity, including but not limited to depression or other mood disorder, anxiety disorder, or pervasive mental disorder, that requires pharmacotherapy
- a clinically significant drug sensitivity to stimulants such as amphetamine, dextroamphetamine, methylphenidate, pemoline
- failure to respond to 2 or more adequate courses (dose or duration) of ADHD therapy
- use of any other prescription medications for ADHD (e.g., amphetamine, dextroamphetamine, methylphenidate, pemoline, atomoxetine) after the screening visit
- use of any MAO inhibitors or SSRIs within 2 weeks of the baseline visit
- hypertension, defined as follows (SBP = systolic blood pressure and DBP = diastolic blood pressure):
- ages 6-9 years SBP > 122mmHg or DBP>78mmHg
- ages 10-12 years SBP > 126mmHg or DBP>82mmHg
- ages 13-17 years SBP > 136mmHg or DBP>86mmHg
- hypotension, defined as sitting systolic blood pressure (taken after resting for 5 minutes) of less than 50mmHg for children under 12 years of age or less than 80mmHg for children 12 and older
- a sitting pulse outside the range of 60 through 115 bpm after resting for 5 minutes
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00214981
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 14, 2005
||July 25, 2012
Keywords provided by Teva Pharmaceutical Industries:
Attention Deficit/Hyperactivity Disorder
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 27, 2017
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs