Trial · NCT00066170

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

NCT00066170, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2011-11-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy. Trials, record NCT00066170. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00066170

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy
NCT number: NCT00066170
Status: Completed
Phases: Phase 3
Enrollment: 231 participants, actual
Lead sponsor: Jazz Pharmaceuticals
Conditions: Narcolepsy
Interventions: Xyrem, Xyrem Placebo, Modafinil at established dose, Modafinil (Placebo)
First posted: 2003-08-06
Last updated: 2011-12-29
Results first posted: 2011-11-30

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)	Baseline to Week 8	The Maintenance of Wakefulness Test consisted of four 20 minute tests of the patient's ability to remain awake in soporific conditions. The Mean change from baseline to week 8 in the average MWT number of minutes until sleep onset was the primary endpoint.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)	Baseline to Week 8		Minutes	MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)	Xyrem Placebo + Modafinil Placebo	-2.72	Standard Deviation 4.535	Minutes
Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)	Xyrem + Modafinil Placebo	0.58	Standard Deviation 5.675	Minutes
Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)	Xyrem Placebo + Modafinil at Established Dose	-0.53	Standard Deviation 4.358	Minutes
Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)	Xyrem + Modafinil at Established Dose	2.68	Standard Deviation 5.071	Minutes

Source ClinicalTrials.gov

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Xyrem Placebo + Modafinil Placebo	56
Overall Study	STARTED	Xyrem + Modafinil Placebo	55
Overall Study	STARTED	Xyrem Placebo + Modafinil at Established Dose	63
Overall Study	STARTED	Xyrem + Modafinil at Established Dose	57
Overall Study	Intent to Treat	Xyrem Placebo + Modafinil Placebo	55
Overall Study	Intent to Treat	Xyrem + Modafinil Placebo	50
Overall Study	Intent to Treat	Xyrem Placebo + Modafinil at Established Dose	63
Overall Study	Intent to Treat	Xyrem + Modafinil at Established Dose	54
Overall Study	COMPLETED	Xyrem Placebo + Modafinil Placebo	49
Overall Study	COMPLETED	Xyrem + Modafinil Placebo	45

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events764

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Vision Blurred	Eye disorders	Xyrem Placebo + Modafinil Placebo	1	56
other	Vision Blurred	Eye disorders	Xyrem + Modafinil Placebo	1	55
other	Vision Blurred	Eye disorders	Xyrem Placebo + Modafinil at Established Dose	1	63
other	Vision Blurred	Eye disorders	Xyrem + Modafinil at Established Dose	2	57
other	Nausea	Gastrointestinal disorders	Xyrem Placebo + Modafinil Placebo	1	56
other	Nausea	Gastrointestinal disorders	Xyrem + Modafinil Placebo	12	55
other	Nausea	Gastrointestinal disorders	Xyrem Placebo + Modafinil at Established Dose	2	63
other	Nausea	Gastrointestinal disorders	Xyrem + Modafinil at Established Dose	12	57
other	Vomiting	Gastrointestinal disorders	Xyrem Placebo + Modafinil Placebo	0	56
other	Vomiting	Gastrointestinal disorders	Xyrem + Modafinil Placebo	7	55

1 to 10 of 764Source ClinicalTrials.gov

See all 764 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Xyrem Placebo + Modafinil Placebo
Total, all-cause mortality	Xyrem + Modafinil Placebo
Total, all-cause mortality	Xyrem Placebo + Modafinil at Established Dose
Total, all-cause mortality	Xyrem + Modafinil at Established Dose
Total, other adverse events	Xyrem Placebo + Modafinil Placebo	39	56
Total, other adverse events	Xyrem + Modafinil Placebo	33	55
Total, other adverse events	Xyrem Placebo + Modafinil at Established Dose	34	63
Total, other adverse events	Xyrem + Modafinil at Established Dose	45	57
Total, serious adverse events	Xyrem Placebo + Modafinil Placebo	2	56
Total, serious adverse events	Xyrem + Modafinil Placebo	0	55

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
2281247	BACKGROUND	PubMed
8506453	BACKGROUND	PubMed
11833860	BACKGROUND	PubMed
12627729	BACKGROUND	PubMed
16895262	RESULT	PubMed
21206549	RESULT	PubMed
29221779	DERIVED	PubMed
32356515	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00066170

GET https://conductscience.org/api/trials/v1/NCT00066170/events?page=2

API reference For AI assistants