Sleep Initiation and Maintenance DisordersPhase 1PKiDsNCT00913614
Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With Insomnia
A Phase 1 study testing Eplivanserin (SR46349) in people with Sleep Initiation and Maintenance Disorders, run by Sanofi at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- Eplivanserin (SR46349)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
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
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.
Read more
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.
- Being tested
- Eplivanserin (SR46349)
- Keywords
- insomnia pediatric safety
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eplivanserin (SR46349)Drug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Age Group 6-11 year old - Dose level 1 | Experimental | Not described Receives: Drug: Eplivanserin (SR46349) |
| Age Group 6-11 year old - Dose Level 2 | Experimental | Not described Receives: Drug: Eplivanserin (SR46349) |
| Age Group 6-11 year old - Dose Level 3 | Experimental | Not described Receives: Drug: Eplivanserin (SR46349) |
| Age Group 12-17 year old - Dose level 1 | Experimental | Not described Receives: Drug: Eplivanserin (SR46349) |
| Age Group 12-17 year old - Dose level 2 | Experimental | Not described Receives: Drug: Eplivanserin (SR46349) |
| Age Group 12-17 year old - Dose level 3 | Experimental | Not described Receives: Drug: Eplivanserin (SR46349) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety in terms of adverse events, laboratory tests, vital signs, ECGs
Measured: Up to 12 days following single dose administration
Pharmacokinetics parameters
Measured: on Day 1, Day 2, Day 5, Day 7 and Day 10
Secondary outcomes (2)
Global sleep parameters
Measured: Immediately following single dose administration
Sleep architecture
Measured: Immediately following single dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913614
- Sponsor's protocol ID
- PKD10491
- Acronym
- PKiDs
- Status last verified
- Nov 2010
- First submitted
- 2 Jun 2009
- Last updated
- 30 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00913614
- Acronym / sponsor ID
- PKiDs / PKD10491
- Keywords
- insomnia pediatric safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Age Group 6-11 year old - Dose level 1 | Experimental | Drug: Eplivanserin (SR46349) |
| Age Group 6-11 year old - Dose Level 2 | Experimental | Drug: Eplivanserin (SR46349) |
| Age Group 6-11 year old - Dose Level 3 | Experimental | Drug: Eplivanserin (SR46349) |
| Age Group 12-17 year old - Dose level 1 | Experimental | Drug: Eplivanserin (SR46349) |
| Age Group 12-17 year old - Dose level 2 | Experimental | Drug: Eplivanserin (SR46349) |
| Age Group 12-17 year old - Dose level 3 | Experimental | Drug: Eplivanserin (SR46349) |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eplivanserin (SR46349)Oral administration | Drug | Age Group 12-17 year old - Dose level 1, Age Group 12-17 year old - Dose level 2, Age Group 12-17 year old - Dose level 3, Age Group 6-11 year old - Dose Level 2, Age Group 6-11 year old - Dose Level 3, Age Group 6-11 year old - Dose level 1 |
Primary outcome
Safety in terms of adverse events, laboratory tests, vital signs, ECGs
Time frame: Up to 12 days following single dose administration
Pharmacokinetics parameters
Time frame: on Day 1, Day 2, Day 5, Day 7 and Day 10
2 secondary outcomes
Global sleep parameters
Time frame: Immediately following single dose administration
Sleep architecture
Time frame: Immediately following single dose administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ICD CSD study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eplivanserin (SR46349) in people with Sleep Initiation and Maintenance Disorders, run by Sanofi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety in terms of adverse events, laboratory tests, vital signs, ECGs (time frame: Up to 12 days following single dose administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2010.