Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With Insomnia (PKiDs)

• ClinicalTrials.gov Identifier: NCT00913614
• Recruitment Status: Completed
• First Posted: June 4, 2009
• Last Update Posted: November 30, 2010
• Sponsor: Sanofi
• Information provided by: Sanofi

Study Description

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 appropriate drug and dosage for children of all ages are essential in addressing this health problem that impacts the child and their family. The objective of this study is to evaluate the safety, pharmacokinetics and preliminary efficacy of eplivanserin.

Primary objective: to assess the safety and tolerability after administration of single ascending oral doses of eplivanserin to children aged 6-17 years with insomnia of various origins.

To assess the pharmacokinetics of eplivanserin (and active metabolite: SR141342) after administration of single ascending oral doses of eplivanserin to children aged 6-17 years with insomnia of various origins.

Secondary objective: to assess the effect of single ascending oral doses of eplivanserin on global sleep parameters and sleep architecture measured via polysomnography recordings in children aged 6-17 years old with insomnia of various origins.

Condition or disease	Intervention/treatment	Phase
Sleep Initiation and Maintenance Disorders	Drug: Eplivanserin (SR46349)	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Single Dose, Open Label Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Three Different Eplivanserin Doses in Children Aged 6-17 Years With Insomnia of Various Origins
• Study Start Date: June 2009
• Actual Primary Completion Date: December 2009
• Actual Study Completion Date: December 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Age Group 6-11 year old - Dose level 1	Drug: Eplivanserin (SR46349); Oral administration
Experimental: Age Group 6-11 year old - Dose Level 2	Drug: Eplivanserin (SR46349); Oral administration
Experimental: Age Group 6-11 year old - Dose Level 3	Drug: Eplivanserin (SR46349); Oral administration
Experimental: Age Group 12-17 year old - Dose level 1	Drug: Eplivanserin (SR46349); Oral administration
Experimental: Age Group 12-17 year old - Dose level 2	Drug: Eplivanserin (SR46349); Oral administration
Experimental: Age Group 12-17 year old - Dose level 3	Drug: Eplivanserin (SR46349); Oral administration

Outcome Measures

Primary Outcome Measures :

1. Safety in terms of adverse events, laboratory tests, vital signs, ECGs [ Time Frame: Up to 12 days following single dose administration ]
2. Pharmacokinetics parameters [ Time Frame: on Day 1, Day 2, Day 5, Day 7 and Day 10 ]

Secondary Outcome Measures :

1. Global sleep parameters [ Time Frame: Immediately following single dose administration ]
2. Sleep architecture [ Time Frame: Immediately following single dose administration ]

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.

Contacts and Locations

Locations

United States, New Jersey

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States, 08807

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: ICD CSD; Sanofi

More Information

• Responsible Party: International Clinical Development Study Director, sanofi-aventis
• ClinicalTrials.gov Identifier: NCT00913614
• Other Study ID Numbers: PKD10491
• First Posted: June 4, 2009
• Last Update Posted: November 30, 2010
• Last Verified: November 2010

Keywords provided by Sanofi:

insomnia pediatric safety

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; SR 46349B; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Physiological Effects of Drugs