Trial Outcomes & Findings for Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy (NCT NCT00066170)
NCT ID: NCT00066170
Last Updated: 2011-12-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
231 participants
Primary outcome timeframe
Baseline to Week 8
Results posted on
2011-12-29
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
56
|
55
|
63
|
57
|
|
Overall Study
Intent to Treat
|
55
|
50
|
63
|
54
|
|
Overall Study
COMPLETED
|
49
|
45
|
59
|
48
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
4
|
9
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
4
|
1
|
7
|
|
Overall Study
Serious Adverse Event
|
0
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Non-Compliance with Trial Medicine
|
1
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
3
|
0
|
0
|
0
|
|
Overall Study
Other
|
1
|
5
|
2
|
0
|
Baseline Characteristics
Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy
Baseline characteristics by cohort
| Measure |
Xyrem Placebo + Modafinil Placebo
n=55 Participants
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
n=50 Participants
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
n=63 Participants
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
n=54 Participants
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.
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
41.0 years
STANDARD_DEVIATION 13.35 • n=5 Participants
|
35.1 years
STANDARD_DEVIATION 12.86 • n=7 Participants
|
38.9 years
STANDARD_DEVIATION 15.62 • n=5 Participants
|
38.9 years
STANDARD_DEVIATION 15.87 • n=4 Participants
|
38.6 years
STANDARD_DEVIATION 14.60 • n=21 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
115 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
107 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
43 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
195 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8The 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.
Outcome measures
| Measure |
Xyrem Placebo + Modafinil Placebo
n=56 Participants
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
n=55 Participants
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
n=63 Participants
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
n=57 Participants
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.
|
|---|---|---|---|---|
|
Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)
|
-2.72 Minutes
Standard Deviation 4.535
|
0.58 Minutes
Standard Deviation 5.675
|
-0.53 Minutes
Standard Deviation 4.358
|
2.68 Minutes
Standard Deviation 5.071
|
Adverse Events
Xyrem Placebo + Modafinil Placebo
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Xyrem + Modafinil Placebo
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Xyrem Placebo + Modafinil at Established Dose
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Xyrem + Modafinil at Established Dose
Serious events: 1 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Xyrem Placebo + Modafinil Placebo
n=56 participants at risk
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
n=55 participants at risk
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
n=63 participants at risk
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
n=57 participants at risk
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.
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Cardiac disorders
Palpitations
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Psychiatric disorders
Psychotic Disorder due to a General Condition
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
Other adverse events
| Measure |
Xyrem Placebo + Modafinil Placebo
n=56 participants at risk
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
n=55 participants at risk
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
n=63 participants at risk
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
n=57 participants at risk
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.
|
|---|---|---|---|---|
|
Eye disorders
Vision Blurred
|
1.8%
1/56
|
1.8%
1/55
|
1.6%
1/63
|
3.5%
2/57
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/56
|
21.8%
12/55
|
3.2%
2/63
|
21.1%
12/57
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/56
|
12.7%
7/55
|
3.2%
2/63
|
8.8%
5/57
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/56
|
3.6%
2/55
|
3.2%
2/63
|
5.3%
3/57
|
|
Gastrointestinal disorders
Dry Mouth
|
1.8%
1/56
|
0.00%
0/55
|
1.6%
1/63
|
5.3%
3/57
|
|
General disorders
Asthenia
|
3.6%
2/56
|
1.8%
1/55
|
0.00%
0/63
|
3.5%
2/57
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
4/56
|
9.1%
5/55
|
4.8%
3/63
|
3.5%
2/57
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
7.1%
4/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
1/56
|
7.3%
4/55
|
4.8%
3/63
|
0.00%
0/57
|
|
Nervous system disorders
Headache
|
21.4%
12/56
|
9.1%
5/55
|
11.1%
7/63
|
19.3%
11/57
|
|
Nervous system disorders
Dizziness
|
5.4%
3/56
|
7.3%
4/55
|
3.2%
2/63
|
21.1%
12/57
|
|
Nervous system disorders
Somnolence
|
7.1%
4/56
|
7.3%
4/55
|
3.2%
2/63
|
5.3%
3/57
|
|
Nervous system disorders
Tremor
|
0.00%
0/56
|
5.5%
3/55
|
0.00%
0/63
|
14.0%
8/57
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/56
|
7.3%
4/55
|
0.00%
0/63
|
3.5%
2/57
|
|
Psychiatric disorders
Anxiety
|
3.6%
2/56
|
0.00%
0/55
|
1.6%
1/63
|
7.0%
4/57
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
2/56
|
1.8%
1/55
|
1.6%
1/63
|
3.5%
2/57
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Cardiac disorders
Palpitations
|
3.6%
2/56
|
0.00%
0/55
|
1.6%
1/63
|
1.8%
1/57
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/56
|
3.6%
2/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/56
|
3.6%
2/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Eye disorders
Keratoconjunctivitis Sicca
|
0.00%
0/56
|
3.6%
2/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Eye disorders
Eye Discharge
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Eye disorders
Eye Redness
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Eye disorders
Glaucoma
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Eye disorders
Visual Disturbance
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.6%
2/56
|
0.00%
0/55
|
1.6%
1/63
|
1.8%
1/57
|
|
Gastrointestinal disorders
Constipation
|
3.6%
2/56
|
0.00%
0/55
|
0.00%
0/63
|
3.5%
2/57
|
|
Gastrointestinal disorders
Flatulence
|
1.8%
1/56
|
1.8%
1/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/56
|
0.00%
0/55
|
3.2%
2/63
|
1.8%
1/57
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
3.6%
2/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
2/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Gastrointestinal disorders
Loose Stools
|
3.6%
2/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Gastrointestinal disorders
Aptyalism
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Gastrointestinal disorders
Oral Mucosal Disorder
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Gastrointestinal disorders
Tongue Blistering
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Gastrointestinal disorders
Tongue Dry
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
General disorders
Fatigue
|
3.6%
2/56
|
0.00%
0/55
|
1.6%
1/63
|
1.8%
1/57
|
|
General disorders
Influenza like Illness
|
0.00%
0/56
|
3.6%
2/55
|
1.6%
1/63
|
1.8%
1/57
|
|
General disorders
Pyrexia
|
1.8%
1/56
|
1.8%
1/55
|
1.6%
1/63
|
1.8%
1/57
|
|
General disorders
Feeling Drunk
|
0.00%
0/56
|
1.8%
1/55
|
1.6%
1/63
|
1.8%
1/57
|
|
General disorders
Chest Pain
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
1.8%
1/57
|
|
General disorders
Oedema Peripheral
|
3.6%
2/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
General disorders
Pain
|
0.00%
0/56
|
1.8%
1/55
|
1.6%
1/63
|
0.00%
0/57
|
|
General disorders
Application Site Dermatitis
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
General disorders
Chest Discomfort
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
General disorders
Feeling Cold
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
General disorders
Feeling Hot
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
General disorders
Feeling Hot and Cold
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
General disorders
Gait Abnormal
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
General disorders
Lethargy
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
General disorders
Oedema
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
General disorders
Swelling
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
General disorders
Thirst
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
General disorders
Ulcer
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Infections and infestations
Influenza
|
1.8%
1/56
|
1.8%
1/55
|
1.6%
1/63
|
1.8%
1/57
|
|
Infections and infestations
Sinusitis
|
5.4%
3/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Infections and infestations
Bronchitis
|
1.8%
1/56
|
1.8%
1/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Infections and infestations
Urinary Tract Infection
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
3.5%
2/57
|
|
Infections and infestations
Herpes Simplex
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Infections and infestations
Adenoiditis
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Infections and infestations
Candidiasis
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Infections and infestations
Dental Caries
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Infections and infestations
Lung Infection
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Infections and infestations
Pneumonia
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Infections and infestations
Tracheitis
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Infections and infestations
Viral Infection
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/56
|
1.8%
1/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Injury, poisoning and procedural complications
Back Injury
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Injury, poisoning and procedural complications
Tooth Injury
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Investigations
Weight Increased
|
5.4%
3/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Investigations
White Blood Cell Count Increased
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Investigations
Blood Creatinine Increased
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Investigations
Blood Glucose Abnormal
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Investigations
Blood Lactate Dehydrogenase Abnormal
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Investigations
Blood Potassium Decreased
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Investigations
Eosinophil Count Increased
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Investigations
Heart Rate Increased
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Investigations
Lymphocyte Count Abnormal
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Food Craving
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/56
|
1.8%
1/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Metabolism and nutrition disorders
Fluid Retention
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Metabolism and nutrition disorders
Gout
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.6%
2/56
|
0.00%
0/55
|
3.2%
2/63
|
0.00%
0/57
|
|
Musculoskeletal and connective tissue disorders
Cataplexy
|
1.8%
1/56
|
0.00%
0/55
|
3.2%
2/63
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
5.3%
3/57
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/56
|
1.8%
1/55
|
1.6%
1/63
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/56
|
3.6%
2/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/56
|
3.6%
2/55
|
1.6%
1/63
|
1.8%
1/57
|
|
Nervous system disorders
Ataxia
|
1.8%
1/56
|
1.8%
1/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Nervous system disorders
Hypoaesthesia
|
1.8%
1/56
|
1.8%
1/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Nervous system disorders
memory Impairment
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Nervous system disorders
Muscle Contractions Involuntary
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
1.8%
1/57
|
|
Nervous system disorders
Sinus Headache
|
1.8%
1/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Nervous system disorders
Amnesia
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Nervous system disorders
Burning Sensation
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Nervous system disorders
Disturbance in Attention
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Nervous system disorders
Hypertonia
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Nervous system disorders
Migraine
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Nervous system disorders
Sedation
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Nervous system disorders
Speech Disorder
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Nervous system disorders
Spinal Column Stenosis
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Nervous system disorders
Syncope
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Nervous system disorders
Tension Headache
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Psychiatric disorders
Confusional State
|
1.8%
1/56
|
1.8%
1/55
|
1.6%
1/63
|
1.8%
1/57
|
|
Psychiatric disorders
Disorientation
|
1.8%
1/56
|
1.8%
1/55
|
0.00%
0/63
|
3.5%
2/57
|
|
Psychiatric disorders
Insomnia
|
3.6%
2/56
|
1.8%
1/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Psychiatric disorders
Crying
|
0.00%
0/56
|
1.8%
1/55
|
1.6%
1/63
|
1.8%
1/57
|
|
Psychiatric disorders
Irritability
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
3.5%
2/57
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
3.5%
2/57
|
|
Psychiatric disorders
Sleep Disorder
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
3.5%
2/57
|
|
Psychiatric disorders
Affect Lability
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Psychiatric disorders
Agitation
|
0.00%
0/56
|
1.8%
1/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Psychiatric disorders
Abnormal Dreams
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Psychiatric disorders
Affective Disorder
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Psychiatric disorders
Belligerence
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Psychiatric disorders
Dissociation
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Psychiatric disorders
Euphoric Mood
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Psychiatric disorders
Hallucination
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Psychiatric disorders
Impulsive Behaviour
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Psychiatric disorders
Libido Increased
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Psychiatric disorders
Psychotic Disorder due to a General Medical Condition
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Psychiatric disorders
Restlessness
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Psychiatric disorders
Sleep Attacks
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Renal and urinary disorders
Enuresis
|
0.00%
0/56
|
3.6%
2/55
|
1.6%
1/63
|
1.8%
1/57
|
|
Renal and urinary disorders
Dysuria
|
1.8%
1/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Renal and urinary disorders
Pollakiura
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/56
|
0.00%
0/55
|
3.2%
2/63
|
0.00%
0/57
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
3.6%
2/56
|
1.8%
1/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
3.6%
2/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventialtion
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Passage Irritation
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Skin and subcutaneous tissue disorders
Dermatits Contact
|
1.8%
1/56
|
1.8%
1/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/56
|
3.6%
2/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.8%
1/56
|
1.8%
1/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Skin and subcutaneous tissue disorders
Oily Skin
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
0.00%
0/56
|
0.00%
0/55
|
1.6%
1/63
|
0.00%
0/57
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Vascular disorders
Hot Flush
|
1.8%
1/56
|
0.00%
0/55
|
3.2%
2/63
|
1.8%
1/57
|
|
Vascular disorders
Flushing
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
|
Vascular disorders
Hypertension
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Vascular disorders
Hypotension
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/63
|
1.8%
1/57
|
|
Vascular disorders
Peripheral Coldness
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/63
|
0.00%
0/57
|
Additional Information
Grace Wang, MD Director of Clinical Development & Medical Monitor
Jazz Pharmaceuticals, Inc
Phone: 650-496-3777
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER