Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00856973
First received: March 4, 2009
Last updated: June 7, 2013
Last verified: May 2013
  Purpose

A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.


Condition Intervention Phase
Insomnia
Attention Deficit Hyperactivity Disorder
Drug: eszopiclone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo Controlled, Double Blind, Fixed Dose Study of the Efficacy and Safety of Eszopiclone in Children (6 to 11 Years) and Adolescents (12 to 17 Years) With Attention Deficit/Hyperactivity Disorder Associated Insomnia

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Change From Baseline to the End of the Double- Blind Treatment Period (Week 12) in Polysomnography (PSG) Defined Latency to Persistent Sleep (LPS). [ Time Frame: Baseline (Day 0) to Week 12 ] [ Designated as safety issue: No ]
    A central scoring facility was used to derive the PSG sleep parameters Latency to Persistent Sleep (LPS) from the epochs and stages collected via the PSG recordings. Each epoch is 30 seconds. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Change from BL at Week 12 in LPS was derived from Week 12 LPS subtracted by BL LPS. Latency to persistent sleep (LPS; minutes): time from lights out to the first of 20 consecutive epochs (10 minutes) of non-wake, as determined by PSG recordings.


Secondary Outcome Measures:
  • Change From Baseline (Day 0) to Week 12 in PSG Defined Wake Time After Sleep Onset (WASO) [ Time Frame: Baseline (Day 0) to Week 12 ] [ Designated as safety issue: No ]
    A central scoring facility was used to derive the PSG sleep parameters Wake Time After Sleep Onset (WASO) from the epochs and stages collected via the PSG recordings. Each epoch is 30 seconds. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Change from BL at Week 12 in WASO was derived from Week 12 WASO subtracted by BL WASO. Wake time after sleep onset (WASO; minutes): The number of wake epochs after the onset of persistent sleep to the end of the recording, divided by 2.

  • Change From Baseline in Clinical Global Improvement (CGI)-Parent/Caregiver at Week 12 [ Time Frame: Baseline (Day 0) to Week 12 ] [ Designated as safety issue: No ]
    The CGI-I Parent/Caregiver was completed by the investigator based on interviews and interactions with the subject's parent or caregiver and represented their assessment of severity and improvement in the subject's symptoms since the start of the study. A 7 point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).

  • Change From Baseline in CGI-Child at Week 12 [ Time Frame: Baseline (Day 0) to Week 12 ] [ Designated as safety issue: No ]
    The CGI - I Child was completed by the investigator based on interviews and interactions with the subject and represented the subject's assessment of improvement in his/her symptoms since the start of the study. A 7 point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).

  • Change From Baseline (Day 0) to Week 12 in Conners' ADHD Inattention Rating Scale. [ Time Frame: Baseline (Day 0) to Week 12 ] [ Designated as safety issue: No ]
    The Conners' 3 -Parent Short Form was completed by the parent and provided an assessment of Attention-Deficit/ Hyperactivity Disorder (ADHD) and the most common comorbid problems and disorders in children and adolescents. It is a multi-informant assessment of children and adolescents between 6 and 18 years of age that took into account home, social and school settings. The short version of the Conners' 3 -Parent Short Form was a subset of items from the full-length form, and included the Conners' 3 Content Scales of Inattention, Hyperactivity/Impulsivity, Learning Problems, Executive Functioning, Aggression, and Peer/Family Relations. The scale scores were presented as standardized age and gender based t scores. Inattention score was used for this endpoint. The lowest scale score is 40 (best) and the highest is 90 (worse)].

  • Change From Baseline to Week 12 in Subjective SL (Sleep Latency) [ Time Frame: Baseline (Day 0) to Week 12 ] [ Designated as safety issue: No ]
    A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of SL over a pre-defined time period. SL is subjective time to fall asleep.

  • Change From Baseline to Week 12 in Subjective Wake Time After Sleep Onset (WASO). [ Time Frame: Baseline (Day 0) to Week 12 ] [ Designated as safety issue: No ]
    A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of WASO over a pre-defined time period. WASO is the aggregate duration of awakenings from the time subjects fall asleep until last awakening. Wake time after sleep onset (WASO; minutes): The number of wake epochs after the onset of persistent sleep to the end of the recording, divided by 2.

  • Change From Baseline to Week 12 in PSG Defined Sleep Efficiency (SE) [ Time Frame: Baseline (Day 0) to Week 12 ] [ Designated as safety issue: No ]
    A central scoring facility was used to derive the PSG sleep parameter of Sleep Efficiency (SE) from the epochs and stages collected via the PSG recordings. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Sleep efficiency: (total sleep time)/(total recording time) x 100. For this endpoint, total sleep time was defined as the number of non-wake epochs from the beginning of recording to the end of recording divided by 2. If total recording time was greater than 960 epochs (480 minutes), total sleep time was calculated from the PSG truncated at 480 minutes.

  • Change From Baseline to Week 12 in PSG Defined Number of Awakenings After Sleep Onset (NAASO). [ Time Frame: Baseline (Day 0) to Week 12 ] [ Designated as safety issue: No ]
    A central scoring facility was used to derive the PSG sleep parameter of Number of Awakenings after Sleep Onset (NAASO). The PSG parameters provided an objective assessment of the subject's sleep on a given night. Number of awakenings: The number of times, after onset of persistent sleep, that there was a wake entry of at least one-minute duration. Each awakening must have been separated by an epoch of non rapid eye movement (NREM) sleep stage 2, 3/4, or rapid eye movement (REM) sleep.

  • Change From Baseline to Week 12 in PSG Defined Total Sleep Time (TST) [ Time Frame: Baseline (Day 0) to Week 12 ] [ Designated as safety issue: No ]
    A central scoring facility was used to derive the PSG sleep parameter of Total Sleep Time (TST) from the epochs and stages collected via the PSG recordings. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Total sleep time was defined as the number of non-wake epochs from the beginning of recording to the end of recording divided by 2. If total recording time was greater than 960 epochs (480 minutes), total sleep time was calculated from the PSG truncated at 480 minutes.

  • Change From Baseline to Week 12 in Subjective Total Sleep Time (TST). [ Time Frame: Baseline (Day 0) to Week 12 ] [ Designated as safety issue: No ]
    A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of TST over a pre-defined time period. TST is subjective total sleep time.

  • Change From Baseline to Week 11 in Subjective Sleep Latency (SL) Measured by Actigraphy Monitoring in the Actigraphy Population. [ Time Frame: Baseline (Day 0) to Week 11 ] [ Designated as safety issue: No ]
    A central scoring facility was used to derive the actigraphy sleep parameter of Sleep Latency (SL). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.

  • Change From Baseline to Week 11 in Subjective WASO From Actigraphy Population. [ Time Frame: Baseline (Day 0) to Week 11 ] [ Designated as safety issue: No ]
    A central scoring facility was used to derive the actigraphy sleep parameters Wake Time After Sleep Onset (WASO). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.

  • Change From Baseline to Week 11 in Total Sleep Time (TST) Measured by Actigraphy Monitoring in the Actigraphy Population. [ Time Frame: Baseline (Day 0) to Week 11 ] [ Designated as safety issue: No ]
    A central scoring facility was used to derive the actigraphy sleep parameter of Total Sleep Time (TST). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.

  • Change From Baseline to Week 12 in Pediatric Daytime Sleepiness Scale (PDSS) Total Score. [ Time Frame: Baseline (Day 0) to Week 12 ] [ Designated as safety issue: No ]
    The PDSS is a validated measure of excessive sleepiness specifically designed for use in school aged children. The scale allowed for measurement of sleepiness across several relatively sedentary activities and provided a means to unmask sleepiness that may not be recognized during more active situations. It consisted of 8 items that assessed the frequency of a sleep related behavior (eg, how often do you fall asleep or get drowsy during class periods; are you usually alert most of the day; how often do you think you need more sleep) using a 5-point Likert type scale (0 = never, 4 = always). All items were summed to obtain the PDSS total score. PDSS data were used for efficacy evaluation as well as for the evaluation of residual effects.The overall PDSS scores range from a low of 0 where the individual is endorsing each item at the lowest level of sleepiness to a high of 32 where the individual is endorsing each item at the highest level of sleepiness.

  • Change From Baseline to Week 12 in Coding Copy Subtest / Digit Symbol Substitution Test (DSST) Scaled Score. [ Time Frame: Baseline (Day 0) to Week 12 ] [ Designated as safety issue: No ]
    These tests are standardized information processing tasks to assess recognition and recoding of sensory information. The subject was given 90 seconds to complete as many substitutions of symbols as possible according to a code provided on top of the sheet. The Coding Copy Subtest A was used for subjects 6-7 years of age and the Coding Copy Subtest B was used for subjects 8-16 years of age, and the DSST was used for subjects 17 years of age. The score is the number of squares filled in correctly. Individuals are measured against their own pre-treatment baseline to determine levels of impairment using the scaled score. Higher scores mean less impairment (or potentially improvement) as the number of correct substitutions generally improves as cognition improves. Scaled scores are used to account for age differences among test takers. Scaled scores range from 1 to 19, and higher scores indicate higher cognitive function.

  • Change From Baseline to Week 12 in Pediatric Quality-of-Life Scale (Short Form-10). [ Time Frame: Baseline (Day 0) to Week 12 ] [ Designated as safety issue: No ]
    The SF 10 Health Survey for Children is a 10 item care-giver completed assessment designed to measure children's health-related quality of life. The scale asked questions about the child's physical wellness, feelings, behavior, and activities at school and with family and friends. The SF 10 Physical and Psychosocial summary measures were scored such that higher scores indicated more favorable functioning.

  • Change From Baseline to Week 12 in Subjective Number of Awakenings After Sleep Onset (NAASO). [ Time Frame: Baseline (Day 0) to Week 12 ] [ Designated as safety issue: No ]
    A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of NAASO over a pre-defined time period.

  • Change in School Tardiness/Attendance Reports at Week 12 (Days) [ Time Frame: Baseline (Day 0) to Week 12 ] [ Designated as safety issue: No ]
    School tardiness/attendance reports were to be collected when subject was actively enrolled in school (fall and spring semesters only; summer school, camps or other school attendance was not recorded.) The School Tardiness Report captured the number of days that the subject was tardy to school, had partial attendance at school or was completely absent from school. Data were collected for the 30-day period prior to Baseline, 6-week period prior to Week 6, 6-week period prior to Week 12.

  • Change in School Tardiness/Attendance Reports at Week 12 (Hours) [ Time Frame: Baseline (Day 0) to Week 12 ] [ Designated as safety issue: No ]
    School tardiness/attendance reports were to be collected when subject was actively enrolled in school (fall and spring semesters only; summer school, camps or other school attendance was not recorded.) The School Tardiness Report captured the number of days that the subject was tardy to school, had partial attendance at school or was completely absent from school. Data were collected for the 30-day period prior to Baseline, 6-week period prior to Week 6, 6-week period prior to Week 12.


Enrollment: 486
Study Start Date: May 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose eszopiclone
1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
Drug: eszopiclone
1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
Experimental: High dose eszopiclone
2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
Drug: eszopiclone
2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
Placebo Comparator: Placebo
Placebo 6-17 years
Drug: Placebo
1 tablet per day for 12 weeks

Detailed Description:

This is a multi center, randomized, double blind, placebo controlled, fixed dose study of eszopiclone in pediatric subjects 6-17 years of age, inclusive, with ADHD associated insomnia. Subjects will be randomized at approximately 1:1:1 to either low dose oral eszopiclone (1 mg for children ages 6-11 years, 2 mg for adolescents ages 12-17 years), high dose oral eszopiclone (2 mg for children ages 6-11 years, 3 mg for adolescents ages 12-17 years) or placebo. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is male or female 6 to 17 years of age, inclusive, at the time of consent.
  • Subject must have a diagnosis of ADHD as defined by DSM-IV criteria
  • Subject must have documented ADHD associated insomnia, defined as the subject or subject's parent/legal guardian having reported repeated difficulty with sleep initiation (sleep latency >30 minutes) or consolidation, (wake time after sleep onset >45 minutes) despite adequate age appropriate time and opportunity for sleep.
  • Subject's Baseline PSG must reveal either >30 minutes latency to persistent sleep (LPS) or >45 minutes wake after sleep onset (WASO).
  • Subject or subject's parent/legal guardian should have reported daytime functional impairment as a result of sleep problems.
  • Subject or subject's parent/legal guardian should have reported attempted and failed behavioral interventions for sleep problems, including a regular bedtime and rise time
  • Subject's sleep disturbance must not be attributable to either the direct physiologic effect of a drug of abuse or misuse of a prescribed medication whether it is being used as intended or in an illicit manner.(Female subjects ≥8 years of age must have a negative serum pregnancy test)
  • Subject must be in general good health
  • Subject must be able to swallow tablets.
  • If subject is currently taking medication for ADHD, they must be on a stable dose and regimen for a minimum of 1 month prior to the time of consent

Exclusion Criteria:

  • Subject with weight <10th percentile for age and gender
  • Subject has any clinically significant or unstable medical illness/abnormality or chronic disease.
  • Subject has a documented history of Bipolar I or II Disorder, major depression, conduct disorder, generalized anxiety disorder or any history of psychosis.
  • Subject has periodic limb movement >5 times per hour, as demonstrated on Baseline PSG.
  • Subject has sleep disordered breathing, as demonstrated on Baseline PSG.
  • Subject has another primary sleep disorder, a secondary sleep disorder, or any other known or suspected medical or psychiatric condition that has affected or may affect sleep
  • Subject has a history of circadian rhythm disorder or will travel across ≥3 time zones more than once during the study.
  • Subject has organic brain disease, or a history of febrile seizures.
  • Subject is, in the opinion of the investigator, at suicidal or homicidal risk.
  • Female subject who is pregnant or lactating or planning to become pregnant.
  • Subject has taken any psychotropic medication without an appropriate washout period (≥5 half-lives) prior to randomization.
  • Subject has a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
  • Subject has a history of allergic reaction or has a known or suspected sensitivity to racemic zopiclone, eszopiclone, or any substance that is contained in the formulation.
  • Subject has a history of alcohol or substance abuse within 3 months of study participation.
  Contacts and Locations
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: NCT00856973

  Hide Study Locations
Locations
United States, Alabama
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States, 35213
Dothan Behavioral Medicine Clinic
Dothan, Alabama, United States, 36303
United States, Arizona
Metropolitan Neuro Behavioral Institute
Chandler, Arizona, United States, 85226
PsyPharma Clinical Research
Phoenix, Arizona, United States, 85050
REM Medical Clinical Research
Tucson, Arizona, United States, 85712
United States, Arkansas
Paul E. Wylie
Little Rock, Arkansas, United States, 72211
United States, California
AV Institute, Inc.
Carson, California, United States, 90746
Clinical Innovations, Inc.
Costa Mesa, California, United States, 92626
Avastra Clinical Trials
Fountain Valley, California, United States, 92708
Behavioral Research Specialists, LLC
Glendale, California, United States, 91204
Pacific Institute for Medical Research Inc
Los Angeles, California, United States, 90024
North County Clinical Research (NCCR)
Oceanside, California, United States, 92056
Excell Research, Inc.
Oceanside, California, United States, 92056
Pacific Clinical Research Medical Group
Orange, California, United States, 92868
SDS Clinical Trials
Orange, California, United States, 92868
California Clinical Trials Medical Group
Paramount, California, United States, 90723
Clinical Innovations, Inc.
Riverside, California, United States, 92506
Clinical Innovations, Inc.
San Diego, California, United States, 92128
Artemis Institute for Clinical Research
San Diego, California, United States, 92123
Neuropsychiatric Research Center of Orange County
Santa Ana, California, United States, 92701
Clinical Innovations, Inc.
Santa Ana, California, United States, 92705
Elite Clinical Trials
Wildomar, California, United States, 92595
United States, Colorado
Delta Waves, INC
Colorado Springs, Colorado, United States, 80918
United States, Florida
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
MD Clinical
Hallandale Beach, Florida, United States, 33009
Florida Clinical Research Center LLC
Maitland, Florida, United States, 32751
Florida Institute for Clinical Research, LLC
Orlando, Florida, United States, 32822
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, United States, 33609
SomnoMedics, LLC
Tampa, Florida, United States, 33607
United States, Georgia
Neuro Trials Research, Inc.
Atlanta, Georgia, United States, 30342
Sleep Disorders Center of Georgia
Atlanta, Georgia, United States, 30342
United States, Idaho
Mountain West Clinical Trials
Eagle, Idaho, United States, 83616
United States, Illinois
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States, 60169
AMR Baber Research Inc.
Naperville, Illinois, United States, 60563
American Medical Research, Inc.
Oak Brook, Illinois, United States, 60523
United States, Indiana
Davis Clinic
Indianapolis, Indiana, United States, 46260
Goldpoint Clinical Research
Indianapolis, Indiana, United States, 46260
United States, Kansas
Psychiatric Associates
Overland Park, Kansas, United States, 66211
United States, Kentucky
Pedia Research LLC
Owensboro, Kentucky, United States, 42301
United States, Louisiana
Louisiana Research Associates, Inc.
New Orleans, Louisiana, United States, 70114
United States, Maryland
Clinical Insights
Glen Burnie, Maryland, United States, 21061
United States, Massachusetts
Neurocare, Inc.
Newton, Massachusetts, United States, 02459
United States, Michigan
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, United States, 48302
Mid-Michigan Sleep Center
Grand Blanc, Michigan, United States, 48439
Clinical Neurophysiology Services, P.C.
Troy, Michigan, United States, 48085
United States, Missouri
Midwest Research Group
St. Charles, Missouri, United States, 63301
United States, Nebraska
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, United States, 68510
United States, Nevada
Clinical Research Center of Nevada
Henderson, Nevada, United States, 89015
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States, 89128
United States, New Jersey
CRI Worldwide, LLC
Willingboro, New Jersey, United States, 08046
United States, New York
Synergy Clinical Research Center
Farmingdale, New York, United States, 11735
United States, Ohio
Tristate Sleep Disorders Center
Cincinnati, Ohio, United States, 45246
MD & Associates, Inc.
Garfield Heights, Ohio, United States, 44125
United States, Oklahoma
Eminence Research, LLC
Oklahoma City, Oklahoma, United States, 73139
IPS Reserach Company
Oklahoma City, Oklahoma, United States, 73103
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States, 73116
Pahl Pharmaceutical Professionals, LLC
Oklahoma City, Oklahoma, United States, 73112
Paradigm Research Professional, LLP
Tulsa, Oklahoma, United States, 74114
Tulsa Clinical Research
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Cyn3rgy Research
Gresham, Oregon, United States, 97030
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, United States, 97210
United States, Pennsylvania
CRI Worldwide
Philadelphia, Pennsylvania, United States, 19139
United States, South Carolina
Carolina Clinical Trials Inc.
Charleston, South Carolina, United States, 29405
United States, Texas
InSite Clinical Research LLC
DeSoto, Texas, United States, 75115
Claghorn-Lesem Research Clinic
Houston, Texas, United States, 77008
Todd J. Swick, MD, PA
Houston, Texas, United States, 77063
Allegiant Clinical Research, LLC
Houston, Texas, United States, 77024
MD
Houston, Texas, United States, 77042
MD
Lubbock, Texas, United States, 79423
The Mech Center
Plano, Texas, United States, 75024
United States, Utah
Aspen Clinical Research, LLC
Orem, Utah, United States, 84058
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Eastside Therapeutic Resource
Kirkland, Washington, United States, 98033
Sponsors and Collaborators
Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00856973     History of Changes
Other Study ID Numbers: 190-246
Study First Received: March 4, 2009
Results First Received: November 2, 2012
Last Updated: June 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Hypnotic
Eszopiclone
Attention Deficit/Hyperactivity Disorder
Insomnia
Children
Adolescent
Polysomnography
Actigraphy

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Sleep Initiation and Maintenance Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014