Status:
COMPLETED
Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With Insomnia
Lead Sponsor:
Sanofi
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
6-17 years
Phase:
PHASE1
Brief Summary
Given the potential age-related differences in safety, tolerability, pharmacokinetics, and differences in sleep architecture in young children versus adolescent versus adult, studies to identify the a...
Eligibility Criteria
Inclusion
- Children with a diagnosis of insomnia of various origins.
- Complaint of childhood insomnia as defined by repeated difficulty with sleep initiation or consolidation that occurs despite adequate age appropriate time and opportunity for sleep. The existence of sleep difficulty will be supported by statements from the child and/or the caregiver that sleep is not properly initiated or maintained.
- Written consent must be obtained from the parent/legal guardian.
- Written assent must be obtained from children of the appropriate age who are capable of giving assent as determined by parent/legal guardian.
Exclusion
- The sleep disturbance must not be attributable to either the direct physiologic effect of a drug of abuse or misuse of a prescribed medication.
- Subject, if female of childbearing potential, which are unwilling to abstain from sexual intercourse or practice a double contraception method for the length of the study.
- Mental retardation.
- The presence of any untreated or uncompensated clinically significant renal, endocrine, hepatic, respiratory, cardiovascular, neurologic (excluding ADHD), hematologic, immunologic, cerebrovascular disease, or malignancy.
- Subjects with a history of any significant gastrointestinal disease.
- Presence of drug or alcohol abuse within one year before inclusion.
- Current history of substance abuse/dependence.
- Pregnant or breast-feeding.
- Use of any hypnotics/psychotropics, antihistamines, melatonin, herbal products, or other sleep aids including clonidine for initiation or maintenance of sleep within one week or five half lives (whichever is longer), prior to screening and unwillingness to discontinue them at the screening visit.
- Subject tested positive at screening or at baseline or at Day 1, on urine drug screen for drugs known to alter sleep (amphetamine/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates and alcohol).
- Inability to swallow a pill in similar size as the tablets to be administered for this study.
- Current or recent (\<60 days) participation in another clinical trial receiving an investigational drug.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00913614
Start Date
June 1 2009
End Date
December 1 2009
Last Update
November 30 2010
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807