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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00913614
First received: June 2, 2009
Last updated: November 29, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Sleep Initiation and Maintenance Disorders
Drug: Eplivanserin (SR46349)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Safety in terms of adverse events, laboratory tests, vital signs, ECGs [ Time Frame: Up to 12 days following single dose administration ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics parameters [ Time Frame: on Day 1, Day 2, Day 5, Day 7 and Day 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global sleep parameters [ Time Frame: Immediately following single dose administration ] [ Designated as safety issue: No ]
  • Sleep architecture [ Time Frame: Immediately following single dose administration ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: June 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
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
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: NCT00913614

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

No publications provided

Responsible Party: International Clinical Development Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00913614     History of Changes
Other Study ID Numbers: PKD10491
Study First Received: June 2, 2009
Last Updated: November 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
insomnia pediatric safety

Additional relevant MeSH terms:
SR 46349B
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014