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NarcolepsyPhase 1NCT01624480

Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy

A Phase 1 study testing Armodafinil in people with Narcolepsy, run by Teva Branded Pharmaceutical Products R&D, Inc. at 24 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to evaluate the pharmacokinetics, pharmacodynamics, and safety of single and multiple doses of armodafinil (50, 100, and 150 mg/day) in children and adolescents with excessive sleepiness associated with narcolepsy. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Narcolepsy
What is being tested?
Armodafinil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
24 sitesin 2 countries
Study dates
Jul 2012to Dec 2015
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

  • Written informed consent is obtained from each patient's parent or legal guardian and written assent is obtained from each patient.
  • The patient is a male or female 6 through 17 years of age with a body mass index (BMI) equal to or greater than 10th percentile for age and gender, inclusive.
  • The patient has a diagnosis of narcolepsy with cataplexy or narcolepsy without cataplexy according to the criteria established by the International Classification of Sleep Disorders (ICSD)-2 for narcolepsy.

Who cannot join

  • The patient has any clinically significant uncontrolled medical condition (treated or untreated) other than narcolepsy.
  • The patient has a clinically significant deviation from normal in ECG, physical examination or vital sign findings, as determined by the investigator or medical monitor.
  • The patient is pregnant or lactating. (Any patient becoming pregnant during the study will be withdrawn from the study)
  • The patient has any history of seizures, including febrile seizures, or a family history of seizures (in parents or siblings) which is not a consequence of trauma, stroke, or metabolic disturbance.
  • The patient has a history of head trauma associated with loss of consciousness.
  • The patient has current suicidal ideation, a history of a suicidal ideation, or a history of a suicide attempt.
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  • The patient has a history of major depressive disorder, bipolar disorder, other significant mood disorders, schizophrenia and other psychotic disorders, eating disorders, or has a family history of suicide.
  • The patient has left ventricular hypertrophy or the patient has mitral valve prolapse and has experienced mitral valve prolapse syndrome.
  • The patient has received any investigational drug within 30 days or 5 half-lives (whichever is longer) before the 1st dose of study drug, or in the case of a new chemical entity, 3 months or 5 half-lives (whichever is longer) before the 1st dose of study drug.
  • The patient has used any monoamine oxidase inhibitors (MAOIs) or stimulants within 14 days or 5 half-lives (whichever is longer) of the baseline visit.
  • The patient has used modafinil or armodafinil within 4 weeks of the baseline visit.
  • The patient has used an inducer of CYP3A4/5 within 28 days prior to study drug administration.
  • The patient has used an inhibitor of CYP3A4/5 within 14 days or 5 half lives (whichever is longer) prior to study drug administration.
  • The patient has a known sensitivity or idiosyncratic reaction to any compound present in modafinil or armodafinil, their related compounds, or to any metabolites or compound listed as being present in these medications.
  • The patient has a history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reactions
  • Other criteria apply, please contact the investigator for additional information

Trial locations and contacts

24 sites in 2 countries.

24 sites in 2 countries

United States23 sites

  • Teva Investigational Site 1

    Atlanta, Georgia

  • Teva Investigational Site 2

    Atlanta, Georgia

  • Teva Investigational Site 12

    Birmingham, Alabama

  • Teva Investigational Site 17

    Birmingham, Alabama

  • Teva Investigational Site 9

    Clearwater, Florida

  • Teva Investigational Site 27

    Everett, Washington

  • Teva Investigational Site 15

    Grand Blanc, Michigan

  • Teva Investigational Site 8

    Houston, Texas

  • Teva Investigational Site 7

    Little Rock, Arkansas

  • Teva Investigational Site 20

    Louisville, Kentucky

  • Teva Investigational Site 26

    Miami Lakes, Florida

  • Teva Investigational Site 13

    Oklahoma City, Oklahoma

  • Teva Investigational Site 18

    Orange, California

  • Teva Investigational Site 23

    Raleigh, North Carolina

  • Teva Investigational Site 14

    San Antonio, Texas

  • Teva Investigational Site 16

    San Diego, California

  • Teva Investigational Site 24

    Seattle, Washington

  • Teva Investigational Site 5

    Spring Hill, Florida

  • Teva Investigational Site 4

    Stanford, California

  • Teva Investigational Site 10

    Toledo, Ohio

  • Teva Investigational Site 19

    West Chester, Pennsylvania

  • Teva Investigational Site 3

    West Seneca, New York

  • Teva Investigational Site 25

    Winter Park, Florida

Other trials in United States

Finland1 site

  • Teva Investigational Site 200

    Helsinki

Other trials in Finland

About this study

Official title: A Randomized, Open-Label Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Single and Multiple Doses of Armodafinil (50, 100, and 150 mg/Day) in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy

This study is to evaluate the pharmacokinetics, pharmacodynamics, and safety of single and multiple doses of armodafinil (50, 100, and 150 mg/day) in children and adolescents with excessive sleepiness associated with narcolepsy.

Conditions
Narcolepsy
Being tested
Armodafinil
Keywords
Pediatric Narcolepsy
Medical subject headings
Narcolepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ArmodafinilDrug

    Also called R-modafinil, CEP-10953

    The armodafinil tablets to be used in this study contain 50 mg of armodafinil and the following inactive ingredients: lactose monohydrate, starch, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and povidone.

Study groups in NCT01624480
Study groupRoleWhat they receive
Armodafinil 50 mgExperimentalIn period 1, patients will receive a single 50-mg dose of armodafinil on day 1. In period 2, patients will receive a single 50-mg dose daily on days 1 through 42.
Receives: Drug: Armodafinil
Armodafinil 100 mgExperimentalIn period 1, patients will receive a single 100 mg dose of armodafinil on day 1. In period 2, patients will receive a single 50-mg dose on day 1 then daily 100-mg doses on days 2 through 42.
Receives: Drug: Armodafinil
Armodafinil 150 mgExperimentalIn period 1, patients will receive a single 150-mg dose of armodafinil on day 1. In period 2, patients will receive a single 50-mg dose on day 1, 100-mg doses on days 2 and 3, then daily 150-mg doses on days 4 through 42.
Receives: Drug: Armodafinil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum observed plasma drug concentration (Cmax) by inspection

    Measured: Day 1 + up to 72 hours after administration

  2. Time to maximum observed plasma drug concentration (tmax) by inspection

    Measured: Day 1 + up to 72 hours after administration

  3. Area under the plasma drug concentration by time curve from time 0 to infinity

    Measured: Day 1 + up to 72 hours after administration

  4. Area under the plasma drug concentration by time curve from time 0 to the time of the last measurable drug concentration

    Measured: Day 1 + up to 72 hours after administration

  5. Terminal half-life

    Measured: Day 1 + up to 72 hours after administration

  6. Terminal elimination rate constant

    Measured: Day 1 + up to 72 hours after administration

  7. Apparent total plasma clearance

    Measured: Day 1 + up to 72 hours after administration

  8. Apparent volume of distribution

    Measured: Day 1 + up to 72 hours after administration

  9. Predicted accumulation ratio

    Measured: Day 1 + up to 72 hours after administration

  10. Maximum observed plasma drug concentration (Cmax)

    Measured: Day 42 + up to 72 hours after administration

  11. Time to maximum observed plasma drug concentration

    Measured: Day 42 + up to 72 hours after administration

  12. AUC over 1 dosing interval

    Measured: Day 42 + up to 72 hours after administration

  13. AUC 0-t

    Measured: Day 42 + up to 72 hours after administration

  14. Observed accumulation ratio

    Measured: Day 42 + up to 72 hours after administration

  15. Steady-state accumulation ratio

    Measured: Day 42 + up to 72 hours after administration

Secondary outcomes (5)

  1. Mean sleep latency

    An objective assessment of sleepiness that measures the likelihood of falling asleep. The test consists of multiple naps performed on the day before study drug administration in period 1 and on the day of study drug administration in period 1. For each nap, sleep latency will be measured as the elapsed time from lights-out to the first epoch scored as sleep. Mean sleep latency is calculated for each day as the average of the sleep latencies from each nap on that day.

    Measured: 2 Days (Baseline + Day 1)

  2. Mean sleep latency

    An assessment by the investigator of change in the patient's severity of excessive sleepiness during the course of the study. The clinician will ask the guardian to assess the child's home behavior over the past week.

    Measured: Day 42

  3. Clinical Global Impression of Change (CGI-C)

    An assessment by the investigator of change in the patient's severity of excessive sleepiness during the course of the study. The clinician will ask the guardian to assess the child's home behavior over the past week.

    Measured: Day 1

  4. Clinical Global Impression of Change (CGI-C)

    The Clinical Global Impression of Change (CGI-C) is an assessment by the investigator of change in the patient's severity of excessive sleepiness during the course of the study. The clinician will ask the guardian to assess the child's home behavior over the past week. The CGI-C ratings will be assessed using the following 7 categories and scoring assignments: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse

    Measured: Outpatient Visits Weeks 1 through 5, once per week

  5. Clinical Global Impression of Change (CGI-C)

    The Clinical Global Impression of Change (CGI-C) is an assessment by the investigator of change in the patient's severity of excessive sleepiness during the course of the study. The clinician will ask the guardian to assess the child's home behavior over the past week. The CGI-C ratings will be assessed using the following 7 categories and scoring assignments: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse

    Measured: Day 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionSep 2015
  4. Study completionDec 2015

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01624480
Sponsor's protocol ID
C10953/1100
Other IDs
2012-005510-20
Status last verified
Nov 2021
First submitted
18 Jun 2012
Last updated
9 Nov 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Armodafinil in people with Narcolepsy, run by Teva Branded Pharmaceutical Products R&D, Inc. at 24 sites in 2 countries.

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 3 inclusion and 16 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 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Finland. 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?

Maximum observed plasma drug concentration (Cmax) by inspection (time frame: Day 1 + up to 72 hours after administration). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01624480.

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 9 Nov 2021.

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