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

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Initiation and Maintenance Disorders
• Intervention / Treatment: Drug: Eplivanserin (SR46349)

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Global sleep parameters	Immediately following single dose administration
Sleep architecture	Immediately following single dose administration

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: June 2, 2009
• First Submitted That Met QC Criteria: June 2, 2009
• First Posted (Estimate): June 4, 2009

Study Record Updates

• Last Update Posted (Estimate): November 30, 2010
• Last Update Submitted That Met QC Criteria: November 29, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: insomnia pediatric safety
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Serotonin Agents; Serotonin Antagonists; SR 46349B
• Other Study ID Numbers: PKD10491