A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy
Status: | Active, not recruiting |
---|---|
Healthy: | No |
Age Range: | 7 - 17 |
Updated: | 6/29/2018 |
Start Date: | October 1, 2014 |
End Date: | June 2019 |
The purpose of this trial is to assess the efficacy and safety of Xyrem in pediatrics
subjects with narcolepsy that includes cataplexy.
subjects with narcolepsy that includes cataplexy.
Inclusion Criteria:
1. Male or female subjects aged 7-16 years at Visit 2 for subjects on Xyrem at study
entry and at Visit 1.1 for Xyrem-naïve subjects (to ensure subjects are <18 years of
age at the end of the study)
2. Have a primary diagnosis of narcolepsy with cataplexy that meets International
Classification of Sleep Disorders (ICSD)-2 or ICSD-3 criteria, whichever was in effect
at the time of the diagnosis or, with the permission of the Medical Monitor, completes
a Multiple Sleep Latency Test (MSLT) during Screening to confirm the diagnosis of Type
1 narcolepsy by ICSD-3 criteria (i.e., the subject meets all other ICSD-3 criteria for
Type 1 narcolepsy)
3. Have given documented assent indicating that he/she was aware of the investigational
nature of the study and the required procedures and restrictions before participation
in any protocol-related activities
4. Have parent(s)/guardian(s) who have given informed consent for his/her/their child's
participation in the study
5. Be willing to spend the required number of nights (2 to 3) in a sleep laboratory for
PSG evaluations
6. If currently treated with Xyrem, must have been taking unchanged doses (twice nightly
dosing no higher than 9 g/night) of Xyrem, and stimulants, if applicable, for the
treatment of narcolepsy symptoms for at least 2 months prior to screening
In addition to the above inclusion criteria, subjects participating in the PK evaluation
must meet the following inclusion criteria:
7. Be willing to spend 2 additional nights in the clinic for PK evaluation
Exclusion Criteria:
1. Inability to understand assent or follow study instructions for any reason, in the
opinion of the Investigator
2. Parent(s) or guardian(s) unable to comply with the requirements of the study for any
reason, in the opinion of the Investigator
3. Other documented clinically significant condition (including an unstable medical
condition, chronic disease other than narcolepsy with cataplexy, or history or
presence of another neurological disorder) that might affect the subject's safety
and/or interfere with the conduct of the study in the opinion of the Investigator
4. Treatment with benzodiazepines, non-benzodiazepine anxiolytics/ hypnotics/sedatives,
neuroleptics, opioids, barbiturates, diclofenac, valproate, phenytoin, ethosuximide
within 2 weeks prior to enrollment (discontinuation for the purpose of study
enrollment is permitted only if considered safe by the Investigator and approved by
the Medical Monitor)
5. Treatment with any other medications that have anticataplectic effect (e.g.,
serotonin-norepinephrine reuptake inhibitors [SNRIs], selective serotonin reuptake
inhibitors [SSRIs], or tricyclic antidepressants [TCAs]) within 1 month before
Screening
6. Unsafe for the subject to receive placebo treatment for 2 weeks, in the opinion of the
Investigator
In addition to the above exclusion criteria, subjects participating in the PK evaluation
must not demonstrate the following:
We found this trial at
33
sites
1720 2nd Ave S
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 934-4011
Principal Investigator: David Lozano, MD
Phone: 205-638-9583
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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3550 Jerome Avenue
Bronx, New York 10467
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Michael Thorpy, MD
Phone: 718-920-4841
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Principal Investigator: Narong Simakajornboon, MD
Phone: 513-636-0607
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Miami Children's Hospital Welcome to Miami Children
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601 Children's Lane
Norfolk, Virginia 23507
Norfolk, Virginia 23507
(757) 668-7000
Principal Investigator: Michael Strunc, MD
Phone: 757-668-7732
Children's Hospital of The King's Daughters Children
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Ann Arbor, Michigan 48109
Principal Investigator: Fauziya Hassan, MD
Phone: 734-615-4302
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13123 E 16th Ave
Aurora, Colorado 80045
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Ann Halbower, MD
Phone: 720-777-8486
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Austin, Texas 78703
Principal Investigator: John Hudson, MD
Phone: 916-934-0569
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300 Longwood Ave
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Kiran Maski, MD
Phone: 617-355-9184
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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225 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 227-4000
Principal Investigator: Stephen Sheldon, MD
Phone: 312-227-4177
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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225 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Columbia, South Carolina 29201
Principal Investigator: RIchard Bogan, MD
Phone: 803-251-3093
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Durham, North Carolina 27710
Principal Investigator: Sujay Kansagra, MD
Phone: 919-684-3747
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Greenville, South Carolina 29615
Principal Investigator: K. Ford Shippey, MD
Phone: 864-454-5660
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Huntersville, North Carolina 28078
Principal Investigator: Thomas Stern, MD
Phone: 704-817-2200
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Long Beach, California 90806
Principal Investigator: Gary Feldman, MD
Phone: 562-933-5607
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Louisville, Kentucky 40217
Principal Investigator: David Winslow, MD
Phone: 502-479-1217
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Metairie, Louisiana 70006
Principal Investigator: Morteza Shamsnia, MD
Phone: 601-341-9130
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New York, New York 10021
Principal Investigator: Sanjeev Kothare, MD
Phone: 917-525-8049
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Oceanside, California 92054
Principal Investigator: Milton Erman, MD
Phone: 858-224-1851
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Orange, California 92868
Principal Investigator: Andrew Schreiber, MD
Phone: 714-834-1565
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Plano, Texas 75024
Principal Investigator: Rajdeep Kakar, MD
Phone: 972-473-7300
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Redwood City, California 94063
Principal Investigator: Chad Ruoff, MD
Phone: 650-721-7550
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4800 Sand Point Way NE
Seattle, Washington 98105
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Maida Chen, MD
Phone: 206-987-2174
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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