Trial Outcomes & Findings for Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy (NCT NCT00132873)

NCT ID: NCT00132873

Last Updated: 2013-11-25

Results Overview

Number of Subjects with treatment-emergent adverse events.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 59 participants
• Primary outcome timeframe: continuous
• Results posted on: 2013-11-25

Participant Flow

Participant milestones

Measure	Xyrem (Sodium Oxybate)
Overall Study STARTED	59
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Xyrem (Sodium Oxybate)
Overall Study Adverse Event	3
Overall Study Lost to Follow-up	1
Overall Study Lack of Efficacy	1
Overall Study Withdrawal by Subject	3
Overall Study Planned Pregnancy	1

Baseline Characteristics

Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy

Baseline characteristics by cohort

Measure	Xyrem (Sodium Oxybate) n=59 Participants
Age Continuous	47.6 years STANDARD_DEVIATION 15.37 • n=5 Participants
Gender Female	41 participants n=5 Participants
Gender Male	17 participants n=5 Participants
Region of Enrollment Canada	59 participants n=5 Participants

PRIMARY outcome

Timeframe: continuous

Number of Subjects with treatment-emergent adverse events.

Outcome measures

Measure	Xyrem (Sodium Oxybate) n=58 Participants
Adverse Experiences	54 participants

PRIMARY outcome

Timeframe: At 1 year

Average Respiratory Rate at 1 year.

Outcome measures

Measure	Xyrem (Sodium Oxybate) n=49 Participants
Vital Signs	14.0 Breaths per minute Standard Deviation 2.40

Adverse Events

Xyrem (Sodium Oxybate)

Serious events: 11 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Measure	Xyrem (Sodium Oxybate) n=58 participants at risk
Cardiac disorders Coronary Artery Disease	1.7% 1/58
Gastrointestinal disorders Diverticulitis	1.7% 1/58
Musculoskeletal and connective tissue disorders Osteoarthritis	3.4% 2/58
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	1.7% 1/58
Infections and infestations Cellulitis	1.7% 1/58
Metabolism and nutrition disorders Dehydration	1.7% 1/58
Infections and infestations Enterocolitis Infectious	1.7% 1/58
Metabolism and nutrition disorders Obesity	1.7% 1/58
Musculoskeletal and connective tissue disorders Joint Swelling	1.7% 1/58
Gastrointestinal disorders Intestinal Obstruction	1.7% 1/58
Musculoskeletal and connective tissue disorders Arthritis	3.4% 2/58
Psychiatric disorders Delusional Disorder, Persecutory Type	1.7% 1/58
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Metastatic	1.7% 1/58
Musculoskeletal and connective tissue disorders Pathological Fracture	1.7% 1/58

Other adverse events

Measure	Xyrem (Sodium Oxybate) n=58 participants at risk
Gastrointestinal disorders Diarrhoea	5.2% 3/58
Gastrointestinal disorders Nausea	5.2% 3/58
General disorders Oedema Peripheral	5.2% 3/58
Infections and infestations Nasopharyngitis	22.4% 13/58
Infections and infestations Urinary Tract Infection	19.0% 11/58
Infections and infestations Influenza	8.6% 5/58
Investigations Blood Pressure Increased	5.2% 3/58
Investigations Weight Increase	5.2% 3/58
Musculoskeletal and connective tissue disorders Pain In Extremity	8.6% 5/58
Musculoskeletal and connective tissue disorders Arthralgia	6.9% 4/58
Musculoskeletal and connective tissue disorders Back Pain	5.2% 3/58
Nervous system disorders Sciatica	6.9% 4/58
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	5.2% 3/58
Vascular disorders Hypertension	10.3% 6/58

Additional Information

Mortimer Mamelak, MD

Jazz Pharmaceuticals, Inc.

Phone: 650 496 3777

Email: roman.skowronski@jazzpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60