Trial Outcomes & Findings for A Study of JZP150 in Adults With Posttraumatic Stress Disorder (NCT NCT05178316)

Last Updated: 2024-12-31

Results Overview

Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) is a clinician administered, clinical interview where participants report on their symptoms of PTSD on a scale. The CAPS-5 total score ranges between 0 and 80. Higher scores indicate more severe PTSD symptoms. Change in CAPS-5 total score is being reported, where negative mean scores indicate an improvement in clinical outcome.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

282 participants

Primary outcome timeframe

Baseline to Week 12

Results posted on

2024-12-31

Participant Flow

A total of 282 participants who met all inclusion criteria and no exclusion criteria were randomized to treatment. Of those 282 participants, 277 received at least 1 dose of study intervention. Five participants did not receive any treatment.

Participant milestones

Participant milestones
Measure	JZP150 0.3 mg Participants who were randomized to JZP150 0.3 mg orally once daily for up to 12 weeks.	JZP150 4.0 mg Participants who were randomized to JZP150 4.0 mg orally once daily for up to 12 weeks.	Placebo Participants who were randomized to placebo orally once daily for up to 12 weeks.
Overall Study STARTED	55	113	109
Overall Study COMPLETED	38	74	78
Overall Study NOT COMPLETED	17	39	31

Reasons for withdrawal

Reasons for withdrawal
Measure	JZP150 0.3 mg Participants who were randomized to JZP150 0.3 mg orally once daily for up to 12 weeks.	JZP150 4.0 mg Participants who were randomized to JZP150 4.0 mg orally once daily for up to 12 weeks.	Placebo Participants who were randomized to placebo orally once daily for up to 12 weeks.
Overall Study Adverse Event	5	4	9
Overall Study Enrolled in Error	1	2	1
Overall Study Lost to Follow-up	3	15	11
Overall Study Noncompliance	1	3	1
Overall Study Other	0	1	0
Overall Study Physician Decision	0	3	2
Overall Study Protocol deviation	1	0	1
Overall Study Sponsor decision	1	0	1
Overall Study Withdrawal by Subject	5	11	5

Baseline Characteristics

Age Group 1 was assessed in the Safety Analysis Set.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	JZP150 0.3 mg n=54 Participants Participants who were randomized to JZP150 0.3 mg orally once daily for up to 12 weeks.	JZP150 4.0 mg n=113 Participants Participants who were randomized to JZP150 4.0 mg orally once daily for up to 12 weeks.	Placebo n=110 Participants Participants who were randomized to placebo orally once daily for up to 12 weeks.	Total n=277 Participants Total of all reporting groups
Age, Continuous	38.4 years STANDARD_DEVIATION 13.54 • n=5 Participants	38.6 years STANDARD_DEVIATION 12.45 • n=7 Participants	41.2 years STANDARD_DEVIATION 12.52 • n=5 Participants	39.6 years STANDARD_DEVIATION 12.72 • n=4 Participants
Age, Customized ≤65 years	53 Participants n=5 Participants • Age Group 1 was assessed in the Safety Analysis Set.	111 Participants n=7 Participants • Age Group 1 was assessed in the Safety Analysis Set.	106 Participants n=5 Participants • Age Group 1 was assessed in the Safety Analysis Set.	270 Participants n=4 Participants • Age Group 1 was assessed in the Safety Analysis Set.
Age, Customized >65 years	1 Participants n=5 Participants • Age Group 1 was assessed in the Safety Analysis Set.	2 Participants n=7 Participants • Age Group 1 was assessed in the Safety Analysis Set.	4 Participants n=5 Participants • Age Group 1 was assessed in the Safety Analysis Set.	7 Participants n=4 Participants • Age Group 1 was assessed in the Safety Analysis Set.
Age, Customized ≤45 years	37 Participants n=5 Participants • Age Group 2 was assessed in the Safety Analysis Set.	79 Participants n=7 Participants • Age Group 2 was assessed in the Safety Analysis Set.	72 Participants n=5 Participants • Age Group 2 was assessed in the Safety Analysis Set.	188 Participants n=4 Participants • Age Group 2 was assessed in the Safety Analysis Set.
Age, Customized >45 years	17 Participants n=5 Participants • Age Group 2 was assessed in the Safety Analysis Set.	34 Participants n=7 Participants • Age Group 2 was assessed in the Safety Analysis Set.	38 Participants n=5 Participants • Age Group 2 was assessed in the Safety Analysis Set.	89 Participants n=4 Participants • Age Group 2 was assessed in the Safety Analysis Set.
Sex: Female, Male Female	44 Participants n=5 Participants	85 Participants n=7 Participants	81 Participants n=5 Participants	210 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	28 Participants n=7 Participants	29 Participants n=5 Participants	67 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	12 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	12 Participants n=5 Participants	16 Participants n=7 Participants	15 Participants n=5 Participants	43 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized White	38 Participants n=5 Participants	92 Participants n=7 Participants	85 Participants n=5 Participants	215 Participants n=4 Participants
Race/Ethnicity, Customized Declined to state	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: CAPS-5 total symptom severity score was assessed in participants with available data in the Full Analysis Set 1.

Outcome measures

Outcome measures
Measure	JZP150 0.3 mg n=44 Participants Participants who were randomized to JZP150 0.3 mg orally once daily for up to 12 weeks.	JZP150 4.0 mg n=79 Participants Participants who were randomized to JZP150 4.0 mg orally once daily for up to 12 weeks.	Placebo n=85 Participants Participants who were randomized to placebo orally once daily for up to 12 weeks.
Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score	-17.0 score on a scale Standard Deviation 13.75	-17.8 score on a scale Standard Deviation 12.59	-17.6 score on a scale Standard Deviation 11.99

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: CGI-S was assessed in participants with available data in the Full Analysis Set 1 (defined as

Clinical Global Impression of Severity (CGI-S) is a clinician assessment used to assess the severity of the participants' PTSD on a scale range of 1 to 7, where 1 indicates "normal, not at all ill" and a 7 indicates "among the most extremely ill participants". Change in CGI-S is being reported with negative mean values indicating an improvement in clinical outcome.

Outcome measures

Outcome measures
Measure	JZP150 0.3 mg n=44 Participants Participants who were randomized to JZP150 0.3 mg orally once daily for up to 12 weeks.	JZP150 4.0 mg n=82 Participants Participants who were randomized to JZP150 4.0 mg orally once daily for up to 12 weeks.	Placebo n=85 Participants Participants who were randomized to placebo orally once daily for up to 12 weeks.
Mean Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)	-1.4 score on a scale Standard Deviation 1.10	-1.3 score on a scale Standard Deviation 1.27	-1.2 score on a scale Standard Deviation 1.08

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: PGI-S was assessed in participants with available data in the Full Analysis Set.

Patient Global Impression of Severity (PGI-S) is a patient assessment designed to evaluate severity of PTSD symptoms on a scale from 1 to 5, where 1 indicates "none" and 5 indicates "very severe". Change in PGI-S is being reported with negative mean values indicating an improvement in clinical outcome.

Outcome measures

Outcome measures
Measure	JZP150 0.3 mg n=44 Participants Participants who were randomized to JZP150 0.3 mg orally once daily for up to 12 weeks.	JZP150 4.0 mg n=81 Participants Participants who were randomized to JZP150 4.0 mg orally once daily for up to 12 weeks.	Placebo n=85 Participants Participants who were randomized to placebo orally once daily for up to 12 weeks.
Mean Change From Baseline to Week 12 in Patient Global Impression of Severity (PGI-S)	-1.0 score on a scale Standard Deviation 1.17	-1.1 score on a scale Standard Deviation 1.11	-1.0 score on a scale Standard Deviation 1.09

Adverse Events

JZP150 0.3 mg

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

JZP150 4.0 mg

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	JZP150 0.3 mg n=54 participants at risk Participants who were randomized to JZP150 0.3 mg orally once daily for up to 12 weeks.	JZP150 4.0 mg n=113 participants at risk Participants who were randomized to JZP150 4.0 mg orally once daily for up to 12 weeks.	Placebo n=110 participants at risk Participants who were randomized to placebo orally once daily for up to 12 weeks.
Nervous system disorders Seizure	1.9% 1/54 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	0.00% 0/113 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	0.00% 0/110 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.
Metabolism and nutrition disorders Dehydration	0.00% 0/54 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	0.88% 1/113 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	0.00% 0/110 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.
Investigations Blood potassium decreased	0.00% 0/54 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	0.88% 1/113 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	0.00% 0/110 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.
Infections and infestations Pneumonia staphylococcal	0.00% 0/54 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	0.00% 0/113 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	0.91% 1/110 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.
Infections and infestations Sepsis	0.00% 0/54 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	0.00% 0/113 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	0.91% 1/110 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.

Other adverse events

Other adverse events
Measure	JZP150 0.3 mg n=54 participants at risk Participants who were randomized to JZP150 0.3 mg orally once daily for up to 12 weeks.	JZP150 4.0 mg n=113 participants at risk Participants who were randomized to JZP150 4.0 mg orally once daily for up to 12 weeks.	Placebo n=110 participants at risk Participants who were randomized to placebo orally once daily for up to 12 weeks.
Gastrointestinal disorders Diarrhoea	7.4% 4/54 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	1.8% 2/113 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	9.1% 10/110 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.
Gastrointestinal disorders Nausea	5.6% 3/54 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	7.1% 8/113 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	3.6% 4/110 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.
General disorders Fatigue	5.6% 3/54 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	3.5% 4/113 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	2.7% 3/110 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.
Nervous system disorders Dizziness	5.6% 3/54 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	3.5% 4/113 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	0.00% 0/110 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.
Nervous system disorders Headache	7.4% 4/54 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	7.1% 8/113 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	5.5% 6/110 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.
Nervous system disorders Somnolence	5.6% 3/54 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	3.5% 4/113 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.	0.91% 1/110 • Adverse events were collected from baseline to Week 12. Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.

Additional Information

Clinical Trial Disclosure & Transparency

Jazz Pharmaceuticals

Phone: 215-832-3750

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place