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

Use our guide to learn which trials are right for you!

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
3411 Wayne Avenue
Bronx, New York 10467
Phone: 718-920-2880
?
mi
from
Bronx, NY
Click here to add this to my saved trials
1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
790 Montclair Road
Birmingham, Alabama 35213
205-599-1020
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Alameda, California 94501
?
mi
from
Alameda, CA
Click here to add this to my saved trials
Anniston, Alabama 36207
?
mi
from
Anniston, AL
Click here to add this to my saved trials
Atlanta, Georgia 30342
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Auburn, Alabama 36832
?
mi
from
Auburn, AL
Click here to add this to my saved trials
Boulder, Colorado 80301
Phone: 601-520-1333
?
mi
from
Boulder, CO
Click here to add this to my saved trials
Charleston, South Carolina 29425
Principal Investigator: Thomas Udhe
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Chesterfield, Missouri
Phone: 314-205-6325
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
Chevy Chase, Maryland 20815
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44194
Phone: 216-844-5112
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Columbia, South Carolina 29201
?
mi
from
Columbia, SC
Click here to add this to my saved trials
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...
?
mi
from
Danville, PA
Click here to add this to my saved trials
Dublin, Ohio 43017
Phone: 614-766-0773
?
mi
from
Dublin, OH
Click here to add this to my saved trials
Fort Wayne, Indiana 46805
Phone: 260-460-3214
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
Houston, Texas 77063
Phone: 713-465-9282
?
mi
from
Houston, TX
Click here to add this to my saved trials
9801 Kincey Avenue
Huntersville, North Carolina 28078
Phone: 704-817-2200
?
mi
from
Huntersville, NC
Click here to add this to my saved trials
Kissimmee, Florida 34741
Phone: 407-624-4831
?
mi
from
Kissimmee, FL
Click here to add this to my saved trials
Little Rock, Arkansas 72205
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Los Angeles, California 90048
Phone: 310-657-1230
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40218
Phone: 502-479-1217
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Miami, Florida 33186
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33126
Phone: 305-994-1825
?
mi
from
Miami, FL
Click here to add this to my saved trials
New York, New York 10019
Principal Investigator: Maha Ahmad
Phone: 212-994-4560
?
mi
from
New York, NY
Click here to add this to my saved trials
8 Devine Street
North Haven, Connecticut 06473
?
mi
from
North Haven, CT
Click here to add this to my saved trials
?
mi
from
Panama City, FL
Click here to add this to my saved trials
?
mi
from
Peoria, IL
Click here to add this to my saved trials
Phoenix, Arizona
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Raleigh, North Carolina 27607
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
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...
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
450 Broadway
Redwood City, California 94063
?
mi
from
Redwood City, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63110
Phone: 314-922-4951
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Ramon, California 94583
Phone: 925-415-5353
?
mi
from
San Ramon, CA
Click here to add this to my saved trials
Santa Ana, California 92705
Phone: 714-834-1565
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Stockbridge, Georgia 30281
Phone: 770-507-8344
?
mi
from
Stockbridge, GA
Click here to add this to my saved trials
?
mi
from
Sydney,
Click here to add this to my saved trials
1788 West Fairbanks Avenue
Winter Park, Florida 32789
?
mi
from
Winter Park, FL
Click here to add this to my saved trials
Winter Park, Florida 32789
?
mi
from
Winter Park, FL
Click here to add this to my saved trials