Evaluate the Safety and Efficacy of Modafinil in Children and Adolescents With ADHD

Sponsor

Cephalon (Industry)

Overall Status

Completed

CT.gov ID

NCT00214981

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

Brief Summary

Primary objective of this study is to evaluate the safety of treatment with modafinil film-coated tablet.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit/Hyperactivity Disorder ADHD	Drug: Modafinil	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Study Start Date :

Sep 1, 2003

Actual Primary Completion Date :

Sep 1, 2006

Actual Study Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

Evaluate the safety of treatment with the modafinil film coated tablet. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama Birmingh	Birmingham	Alabama	United States	35025
2	Pivotal Research Center	Mesa	Arizona	United States	85210
3	River Valley Neurology	Fort Smith	Arkansas	United States	72901
4	Clinical Study Centers, LLC	Little Rock	Arkansas	United States	72205
5	UCI Child Development Center	Irvine	California	United States	92612
6	BMR HealthQuest	San Diego	California	United States	92123
7	University of CA San Francisco	San Francisco	California	United States	94143
8	Encompass Clinical Research	Spring Valley	California	United States	91978
9	Alpine Clinical Research	Boulder	Colorado	United States	80304
10	Sarkis Clinical Trials	Gainesville	Florida	United States	32607
11	Amedica Research Inst.	Hialeah	Florida	United States	33013
12	Children's Developmental Cente	Maitland	Florida	United States	32751
13	Miami Research Associates	Miami	Florida	United States	33173
14	Clinical Neuroscience Solution	West Palm Beach	Florida	United States	33407
15	Child Neurology Assoc.	Atlanta	Georgia	United States	30342
16	Mountainview Center for Resear	Decatur	Georgia	United States	30033
17	Foothills Psychiatry	Boise	Idaho	United States	83702
18	Consultants in Neurology, Ltd.	Northbrook	Illinois	United States	60062
19	Midwest Neurology, Inc.	Danville	Indiana	United States	46122
20	Cientifica at Prarie View	Newton	Kansas	United States	67114
21	Vince and Associates Clinical	Overland Park	Kansas	United States	66211
22	Kentucky Pediatric/Adult Resea	Bardstown	Kentucky	United States	40004
23	Michael J. Rieser, MD	Lexington	Kentucky	United States	40509
24	Pedia Research, LLC	Owensboro	Kentucky	United States	42301
25	Four Rivers Clinical Research	Paducah	Kentucky	United States	42003
26	Dolby Providers, Inc.	New Orleans	Louisiana	United States	70128
27	NeuroScience, Inc.	Bethesda	Maryland	United States	20814
28	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
29	Clinical Neurophysiology Svcs	Troy	Michigan	United States	48085
30	University of Nebraska	Omaha	Nebraska	United States	68198-7630
31	Clinical Research Center of NV	Las Vegas	Nevada	United States	89014
32	Radiant Research Las Vegas	Las Vegas	Nevada	United States	89146-5611
33	CNS Research Institute	Clementon	New Jersey	United States	08021
34	Children's Specialized Hospita	Toms River	New Jersey	United States	08755
35	University of Buffalo	Buffalo	New York	United States	14214
36	New York Psychiatric Inst	New York	New York	United States	10032
37	University of Rochester	Rochester	New York	United States	14642
38	North Carolina Neuropsychiatry	Chapel Hill	North Carolina	United States	27514
39	North Carolina Neuropsychiatry	Charlotte	North Carolina	United States	28209
40	Psychiatric Professional Servi	Cincinnati	Ohio	United States	45267-0559
41	Pahl Pharmaceutical Research	Oklahoma City	Oklahoma	United States	73118
42	OCCI Eugene	Eugene	Oregon	United States	97401
43	Summit Research Network Inc.	Portland	Oregon	United States	97210
44	OCCI, Inc.	Salem	Oregon	United States	97309
45	CNS Research Institute PC	Philadelphia	Pennsylvania	United States	19149
46	Primary Physicians Research	Pittsburgh	Pennsylvania	United States	15241
47	Rhode Island Hospital	Providence	Rhode Island	United States	02903
48	Clinical Neuroscience Solution	Memphis	Tennessee	United States	38119
49	Vanderbilt University Medical	Nashville	Tennessee	United States	37232
50	Dallas Pediatric Neurology	Dallas	Texas	United States	75230
51	UT Health Science Center	San Antonio	Texas	United States	78229-3900
52	Radiant Research Salt Lake	Salt Lake City	Utah	United States	84107
53	Otter Creek Clinical Studies	Burlington	Vermont	United States	05401
54	Monarch Research Associates	Norfolk	Virginia	United States	23510
55	James A. Knutson, MD	Kirkland	Washington	United States	98033
56	Pacific Institute of Mental He	Seattle	Washington	United States	98133-9009
57	Marshfield Clinical Research	Marshfield	Wisconsin	United States	54449