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Clinical Trial Results:
A Long-Term, Safety and Maintenance of Efficacy Study of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy or Obstructive Sleep Apnea

Summary
EudraCT number	2014-005489-31
Trial protocol	FI DE NL FR
Global end of trial date	08 Dec 2017

Results information
Results version number	v1(current)
This version publication date	23 Dec 2018
First version publication date	23 Dec 2018
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

Top of page

Sponsor protocol code

14-005

ISRCTN number

-

US NCT number

NCT02348632

WHO universal trial number (UTN)

-

Sponsor organisation name

Jazz Pharmaceuticals

Sponsor organisation address

3180 Porter Drive, Palo Alto, United States, 94304

Public contact

Clinical Trial Disclosure & Transparency, Jazz Pharmaceuticals Inc., 001 2158323661,

Scientific contact

Clinical Trial Disclosure & Transparency, Jazz Pharmaceuticals Inc., 001 2158323661,

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

08 Dec 2017

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

08 Dec 2017

Was the trial ended prematurely?

No

Main objective of the trial

To evaluate the safety and tolerability of JZP-110 administered once daily for up to 52 weeks in doses of 75, 150, and 300 mg.

Protection of trial subjects

Safety was assessed by the incidence of observed and reported adverse events (AEs), and changes in physical examination findings, electrocardiograms (ECGs), clinical laboratory tests, vital signs, and the Columbia-Suicide Severity Rating Scale (C-SSRS). Safety was assessed throughout the study.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

01 Apr 2015

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

No

Number of subjects enrolled per country

Country: Number of subjects enrolled

Netherlands: 6

Country: Number of subjects enrolled

Finland: 17

Country: Number of subjects enrolled

France: 12

Country: Number of subjects enrolled

Germany: 31

Country: Number of subjects enrolled

Canada: 28

Country: Number of subjects enrolled

United States: 545

Country: Number of subjects enrolled

Italy: 4

Worldwide total number of subjects

643

EEA total number of subjects

70

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

547

From 65 to 84 years

96

85 years and over

0

Subject disposition

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Recruitment details

Note: Subjects who had completed prior studies with JZP-110 (14-002, 14-003, 14-004, 15-004, 15-005, ADX‑N05 201, or ADX‑N05 202) and met the screening criteria were eligible to enroll. 643 subjects comprised the safety population.

Screening details

The Screening phase involved a standard medical screening visit.

Period 1 title

Open-label period

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Combined JZP-110

Arm description

Subjects completed a 2-week titration phase. They then entered the maintenance phase of up to 50 weeks at the stable dose that was reached at the end of the Titration Phase.

Arm type

Experimental

Investigational medicinal product name

JZP-110

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Titration phase: Start at 75 mg, titrate up 1 dose level once every 3 days to a maximum of 300 mg. Subjects could also titrate down if needed. Subjects entered the maintenance phase at the stable dose that was reached at the end of the Titration Phase. Only 3 dose adjustments were allowed during the first 12 weeks of the maintenance phase after which no changes were permitted.

Number of subjects in period 1	Combined JZP-110
Started	643
Completed	458
Not completed	185
Consent withdrawn by subject	27
Adverse event, non-fatal	61
Other	1
Lost to follow-up	14
Treatment noncompliant	7
Sponsor decision	10
Lack of efficacy	54
Protocol deviation	11

Period 2 title

Randomized Withdrawal Period

Is this the baseline period?

No

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Subject

Are arms mutually exclusive

Yes

Placebo

Arm description

Placebo administered orally, QD, for the 2-week randomized withdrawal period.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Placebo administered orally, QD, for the 2-week randomized withdrawal period.

JZP-110

Arm description

JZP-110 administered orally, QD, for the 2-week randomized withdrawal period, at the same dose subjects were currently receiving.

Arm type

Experimental

Investigational medicinal product name

JZP-110

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

JZP-110 administered orally, QD, at the dose subjects were receiving during the open-label maintenance phase.

Number of subjects in period 2 ^[1]	Placebo	JZP-110
Started	142	140
Completed	141	137
Not completed	1	3
Consent withdrawn by subject	-	1
Lost to follow-up	1	-
Treatment noncompliant	-	1
Protocol deviation	-	1

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: 282 subjects were treated in the Randomized Withdrawal Period, and 278 subjects completed the Randomized Withdrawal Period.

Baseline characteristics

Top of page

Reporting group title

Open-label period

Reporting group description

-

Reporting group values	Open-label period	Total
Number of subjects	643	643
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	547	547
From 65-84 years	96	96
85 years and over	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	49.31 ± 14.155	-
Gender categorical
Units: Subjects
Female	306	306
Male	337	337

End points

Top of page

Reporting group title

Combined JZP-110

Reporting group description

Subjects completed a 2-week titration phase. They then entered the maintenance phase of up to 50 weeks at the stable dose that was reached at the end of the Titration Phase.

Reporting group title

Placebo

Reporting group description

Placebo administered orally, QD, for the 2-week randomized withdrawal period.

Reporting group title

JZP-110

Reporting group description

JZP-110 administered orally, QD, for the 2-week randomized withdrawal period, at the same dose subjects were currently receiving.

Primary: Change in Epworth Sleepiness Scale (ESS) Score

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End point title

Change in Epworth Sleepiness Scale (ESS) Score

End point description

Change in ESS score during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. A negative change from baseline represents improvement in excessive sleepiness.

End point type

Primary

End point timeframe

Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks)

End point values	Placebo	JZP-110
Number of subjects analysed	141	139
Units: points on a scale
least squares mean (standard error)	5.3 ± 0.41	1.6 ± 0.41

Change in ESS Score

Statistical analysis description

JZP-110 v. Placebo: <0.0001

Comparison groups

Placebo v JZP-110

Number of subjects included in analysis

280

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

ANCOVA

Confidence interval

Secondary: Subjects Reported as Worse on the Patient Global Impression of Change (PGIc)

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End point title

Subjects Reported as Worse on the Patient Global Impression of Change (PGIc)

End point description

Percentage of subjects reported as worse (minimally worse, much worse, or very much worse) on the PGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline.

End point type

Secondary

End point timeframe

Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)

End point values	Placebo	JZP-110
Number of subjects analysed	141	139
Units: percentage of subjects
number (not applicable)	64.5	28.2

No statistical analyses for this end point

Secondary: Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc)

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End point title

Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc)

End point description

Subjects reported as worse (very much worse, much worse, and minimally worse) on the CGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline.

End point type

Secondary

End point timeframe

Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)

End point values	Placebo	JZP-110
Number of subjects analysed	141	139
Units: percentage of subjects
number (not applicable)	63.8	28.7

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

The Safety Population consisted of all subjects who received at least 1 dose of study medication. Adverse events are reported across the entire study (e.g., the open-label and randomized withdrawal periods combined).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

18.0

Reporting group title

Placebo

Reporting group description

-

Reporting group title

Combined JZP-110

Reporting group description

-

Serious adverse events	Placebo	Combined JZP-110
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 142 (0.00%)	27 / 643 (4.20%)
number of deaths (all causes)	0	1
number of deaths resulting from adverse events		0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage I
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant melanoma
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Stillbirth
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chest discomfort
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Anaphylactic reaction
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Prostatomegaly
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Agitation
subjects affected / exposed	0 / 142 (0.00%)	2 / 643 (0.31%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bipolar I disorder
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hallucination, auditory
subjects affected / exposed	0 / 142 (0.00%)	2 / 643 (0.31%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Depression
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Anaemia postoperative
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol poisoning
subjects affected / exposed	0 / 142 (0.00%)	2 / 643 (0.31%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ear canal injury
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skull fracture
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skull fractured base
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural hypotension
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intentional overdose
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	0 / 142 (0.00%)	4 / 643 (0.62%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Cerebrovascular accident
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness
subjects affected / exposed	0 / 142 (0.00%)	2 / 643 (0.31%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Migraine
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cluster headache
subjects affected / exposed	0 / 142 (0.00%)	2 / 643 (0.31%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Retinal vein occlusion
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	0 / 142 (0.00%)	2 / 643 (0.31%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer haemorrhage
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal inflammation
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis acute
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Haematuria
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Bronchitis
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal infection
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	0 / 142 (0.00%)	1 / 643 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Placebo	Combined JZP-110
Total subjects affected by non serious adverse events
subjects affected / exposed	3 / 142 (2.11%)	269 / 643 (41.84%)
Nervous system disorders
Headache
subjects affected / exposed	0 / 142 (0.00%)	71 / 643 (11.04%)
occurrences all number	0	92
Gastrointestinal disorders
Nausea
subjects affected / exposed	1 / 142 (0.70%)	57 / 643 (8.86%)
occurrences all number	1	68
Dry mouth
subjects affected / exposed	0 / 142 (0.00%)	47 / 643 (7.31%)
occurrences all number	0	55
Psychiatric disorders
Anxiety
subjects affected / exposed	0 / 142 (0.00%)	46 / 643 (7.15%)
occurrences all number	0	52
Insomnia
subjects affected / exposed	1 / 142 (0.70%)	51 / 643 (7.93%)
occurrences all number	1	68
Infections and infestations
Nasopharyngitis
subjects affected / exposed	1 / 142 (0.70%)	54 / 643 (8.40%)
occurrences all number	1	65
Upper respiratory tract infection
subjects affected / exposed	0 / 142 (0.00%)	32 / 643 (4.98%)
occurrences all number	0	39
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	0 / 142 (0.00%)	32 / 643 (4.98%)
occurrences all number	0	33

More information

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Were there any global substantial amendments to the protocol? Yes

18 Feb 2015

This amendment made changes to clarify enrollment criteria.

11 Sep 2015

This amendment made changes to clarify enrollment criteria.

02 Feb 2016

This amendment added the randomized withdrawal period, along with additional study procedures and data analyses as a result of this period, and also increased the maximum enrollment. Changes to clarify the enrollment criteria were also made.

17 Nov 2016

This amendment was made to clarify the number of subjects to be randomized into the randomized withdrawal period.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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