Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy

This study has been completed.

Study NCT00066170 Information provided by Jazz Pharmaceuticals

First Received on August 4, 2003. Last Updated on December 21, 2011 History of Changes

Results First Received: October 21, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Narcolepsy
Interventions:	Drug: Xyrem Drug: Xyrem Placebo Drug: Modafinil at established dose Drug: Modafinil (Placebo)

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Xyrem Placebo + Modafinil Placebo	Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
Xyrem + Modafinil Placebo	Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
Xyrem Placebo + Modafinil at Established Dose	Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
Xyrem + Modafinil at Established Dose	Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.

Participant Flow: Overall Study

	Xyrem Placebo + Modafinil Placebo	Xyrem + Modafinil Placebo	Xyrem Placebo + Modafinil at Established Dose	Xyrem + Modafinil at Established Dose
STARTED	56	55	63	57
Intent to Treat	55	50	63	54
COMPLETED	49	45	59	48
NOT COMPLETED	7	10	4	9
Adverse Event	2	4	1	7
Serious Adverse Event	0	0	1	1
Lost to Follow-up	0	1	0	0
Non-Compliance with Trial Medicine	1	0	0	1
Protocol Violation	3	0	0	0
Other	1	5	2	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Xyrem Placebo + Modafinil Placebo	Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
Xyrem + Modafinil Placebo	Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
Xyrem Placebo + Modafinil at Established Dose	Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
Xyrem + Modafinil at Established Dose	Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.

Baseline Measures

	Xyrem Placebo + Modafinil Placebo	Xyrem + Modafinil Placebo	Xyrem Placebo + Modafinil at Established Dose	Xyrem + Modafinil at Established Dose	Total
Number of Participants [units: participants]	55	50	63	54	222
Age [units: years] Mean ± Standard Deviation	41.0 ± 13.35	35.1 ± 12.86	38.9 ± 15.62	38.9 ± 15.87	38.6 ± 14.60
Gender [units: participants]
Female	31	24	31	29	115
Male	24	26	32	25	107
Race/Ethnicity, Customized [units: Participants]
Caucasian	43	47	57	48	195
Black	11	2	5	3	21
Asian	0	1	0	0	1
Hispanic	1	0	0	1	2
Other	0	0	1	2	3

Outcome Measures

1. Primary:

Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT) [ Time Frame: Baseline to Week 8 ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No text entered.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Grace Wang, MD Director of Clinical Development & Medical Monitor
Organization: Jazz Pharmaceuticals, Inc
phone: 650-496-3777

Publications of Results:

Black J, Houghton WC. Sodium oxybate improves excessive daytime sleepiness in narcolepsy. Sleep. 2006 Jul;29(7):939-46.

Black J, Pardi D, Hornfeldt CS, Inhaber N. The nightly use of sodium oxybate is associated with a reduction in nocturnal sleep disruption: a double-blind, placebo-controlled study in patients with narcolepsy. J Clin Sleep Med. 2010 Dec 15;6(6):596-602.

Other Publications:

[No authors listed] A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002 Feb 1;25(1):42-9.

Scrima L, Hartman PG, Johnson FH Jr, Thomas EE, Hiller FC. The effects of gamma-hydroxybutyrate on the sleep of narcolepsy patients: a double-blind study. Sleep. 1990 Dec;13(6):479-90.

Lammers GJ, Arends J, Declerck AC, Ferrari MD, Schouwink G, Troost J. Gammahydroxybutyrate and narcolepsy: a double-blind placebo-controlled study. Sleep. 1993 Apr;16(3):216-20.

[No authors listed] A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep. 2003 Feb 1;26(1):31-5.

Responsible Party:	Senior Director Clinical Development, Jazz Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00066170 History of Changes
Other Study ID Numbers:	OMC-SXB-22
Study First Received:	August 4, 2003
Results First Received:	October 21, 2011
Last Updated:	December 21, 2011
Health Authority:	United States: Food and Drug Administration