Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:16 - Any
Updated:3/27/2019
Start Date:November 2016
End Date:September 2019
Contact:Siobhan O'Daly
Email:clinicaltrials@flamel.com
Phone:+353 1 4851210

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A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects With Narcolepsy

The purpose of this study is to determine whether FT218 is safe and effective for the
treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.


Inclusion Criteria:

1. Male or female subjects 16 years of age or older

2. Willing and able to give written informed consent for study participation. For young
adults (16 and 17 years old) who have not reached the age of majority they must be
capable of giving assent and consent from a legally authorized guardian must be
obtained, as required by local laws and regulations

3. Documented evidence of a diagnosis of NT1 or NT2 as, in part, determined by an
overnight PSG and next-day MSLT with 2 or more SOREMPs with mean sleep latency in the
pathological range i.e. < 8 minutes and meeting the NT1 and NT2 as defined by the
International Classification of Sleep Disorders -3 criteria.

4. Current continuing presence of EDS as defined by subject report for the last 3 months
and an ESS > 10

5. For NT1 only, current continuing presence of cataplexy as defined by subject report
for the last 3 months

6. Subjects may use concomitant stimulants, but must comply with the following:

1. They must be on a stable dose of stimulants for at least 3 weeks prior to
starting the screening process for this study; AND

2. They must use the same stimulant regimen throughout the entire study period,
including during screening and posttreatment periods

3. They must discontinue all anti cataplexy drugs

7. Addition inclusion criteria per protocol

Exclusion criteria

1. Any prior use of sodium oxybate is allowed in the study but within the following
exclusions:

1. Previous dosing must have been limited to no more than 4.5g per night

2. Patient should not have taken sodium oxybate for more than 2 weeks.

3. All previous dosing must not have occurred within the last year prior to entry to
the study.

2. Current use of sodium valproate

3. Any use of the following prohibited medications for the duration of the clinical
study:

1. Anticonvulsants

2. Clonidine

3. SSRIs and serotonin and norepinephrine re-uptake inhibitors (SNRIs)

4. MAOIs

5. TCAs

6. Hypnotics

7. Anxiolytics

8. Sedating antihistamines

9. Antipsychotics

10. Other experimental medications designed to treat narcolepsy, cataplexy or any
other condition

4. Treatment with any investigational products within 3 months before study enrollment

5. Any drug known to affect sleep-wake function. Concomitant stimulant use is permitted

6. Additional exclusion criteria per protocol
We found this trial at
41
sites
Little Rock, Arkansas 72205
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1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
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790 Montclair Road
Birmingham, Alabama 35213
205-599-1020
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Alameda, California 94501
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Anniston, Alabama 36207
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Atlanta, Georgia 30342
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Auburn, Alabama 36832
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Boulder, Colorado 80301
Phone: 601-520-1333
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3411 Wayne Avenue
Bronx, New York 10467
Phone: 718-920-2880
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Charleston, South Carolina 29425
Principal Investigator: Thomas Udhe
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Chesterfield, Missouri
Phone: 314-205-6325
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Chevy Chase, Maryland 20815
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Cincinnati, OH
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Cleveland, Ohio 44194
Phone: 216-844-5112
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Columbia, South Carolina 29201
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Phone: 570-271-8254
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Dublin, Ohio 43017
Phone: 614-766-0773
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Fort Wayne, Indiana 46805
Phone: 260-460-3214
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Houston, Texas 77063
Phone: 713-465-9282
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9801 Kincey Avenue
Huntersville, North Carolina 28078
Phone: 704-817-2200
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Kissimmee, Florida 34741
Phone: 407-624-4831
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Los Angeles, California 90048
Phone: 310-657-1230
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Louisville, Kentucky 40218
Phone: 502-479-1217
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Miami, Florida 33186
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Miami, Florida 33126
Phone: 305-994-1825
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New York, New York 10019
Principal Investigator: Maha Ahmad
Phone: 212-994-4560
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8 Devine Street
North Haven, Connecticut 06473
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Panama City, FL
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Phoenix, Arizona
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Raleigh, North Carolina 27607
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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450 Broadway
Redwood City, California 94063
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Saint Louis, Missouri 63110
Phone: 314-922-4951
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San Antonio, Texas 78229
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San Ramon, California 94583
Phone: 925-415-5353
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Santa Ana, California 92705
Phone: 714-834-1565
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Stockbridge, Georgia 30281
Phone: 770-507-8344
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1788 West Fairbanks Avenue
Winter Park, Florida 32789
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Winter Park, Florida 32789
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