Excessive SleepinessPhase 2NCT03037203
A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness
A Phase 2 study testing JZP-110 in people with Excessive Sleepiness and Parkinson Disease, run by Jazz Pharmaceuticals at 25 sites in United States.
Trial summary
This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult subjects with idiopathic PD. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Excessive Sleepiness, Parkinson Disease
- What is being tested?
- JZP-110
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 25 sitesUnited States
- Study dates
- Jan 2017to Aug 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic PD according to the UK PDS Brain Bank Criteria.
- Hoehn and Yahr stage 1, 2, or 3.
- Screening and Baseline ESS scores >11.
Who cannot join
- Diagnosis of other degenerative Parkinsonian syndromes (e.g., progressive supranuclear palsy, multiple system atrophy [MSA], or dementia with Lewy bodies [DLB]).
- Usual nightly time in bed of <6 hours, including the night before the Baseline visit.
- Untreated or inadequately treated moderate to severe OSA.
- Has evidence at screening of severe cognitive impairment or has cognitive impairment that in the opinion of the investigator would prevent completion of study procedures or the ability to provide informed consent.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Alpine Clinical Research Center
Boulder, Colorado, 80301
PAB Clinical Research
Brandon, Florida, 33511
St. Lukes Hospital Medical Center
Chesterfield, Missouri, 63017
Center for Sleep & Wake Disorders
Chevy Chase, Maryland, 20815
Rush University Medical Center
Chicago, Illinois, 60612
SleepMed of South Carolina
Columbia, South Carolina, 29201
Rocky Mountain Movement Disorders Center, PC
Englewood, Colorado, 80113
QUEST Research Institute
Farmington Hills, Michigan, 48334
MD Clinical
Hallandale, Florida, 33009
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160
Evergreen Hospital Medical Center
Kirkland, Washington, 98034
Southern California Institute For Respiratory Diseases, Inc.
Los Angeles, California, 90048
QPS MRA (Miami Research Associates)
Miami, Florida, 33143
Villages at Vanderbilt
Nashville, Tennessee, 37232
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Bioclinica Research
Orlando, Florida, 32806
Parkinson's Disease Research Unit - Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Strong Sleep Disorders Center
Rochester, New York, 14618
Pacific Research Network, Inc
San Diego, California, 92103
Premier Clinical Research - Sherman
Spokane, Washington, 99202
Clinical Neurophysiology Services, P.C.
Sterling Heights, Michigan, 48314
USF Health Byrd Institute
Tampa, Florida, 33613
Montefiore Sleep-Wake Disorders Center
The Bronx, New York, 10467
Henry Ford Medical Center - West Bloomfield
West Bloomfield, Michigan, 48322
About this study
Official title: A 4-Week, Double-blind, Placebo-controlled, Randomized, Multicenter, Crossover Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness
This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult subjects with idiopathic PD.
- Conditions
- Excessive Sleepiness, Parkinson Disease
- Being tested
- JZP-110, Placebo
- Medical subject headings
- Disorders of Excessive Somnolence, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JZP-110Drug
75 mg, 150 mg, 300 mg
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | JZP-110 and Placebo Receives: Drug: JZP-110; Other: Placebo |
| Arm B | Experimental | JZP-110 and Placebo Receives: Drug: JZP-110; Other: Placebo |
| Arm C | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation
Measured: Up to Day 35
Secondary outcomes (1)
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score
Change from Baseline ESS defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4).
The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions, asking subjects how likely they would be to doze off or fall asleep in different situations. Responses range from 0 = would never doze to 3 = high chance of dozing. Higher scores represent greater severity of excessive sleepiness. The total score ranges from 0 - 24, with higher scores representing greater severity of excessive sleepiness.
Measured: Baseline to Weeks 1, 2, 3, and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Excessive SleepinessStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Millie Gottwald, PharmD, Study director, Jazz Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037203
- Sponsor's protocol ID
- JZP166-201
- Status last verified
- Jan 2020
- First submitted
- 23 Jan 2017
- Last updated
- 9 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Videnovic A, Amara AW, Comella C, Schweitzer PK, Emsellem H, Liu K, Sterkel AL, Gottwald MD, Steinerman JR, Jochelson P, Zomorodi K, Hauser RA. Solriamfetol for Excessive Daytime Sleepiness in Parkinson's Disease: Phase 2 Proof-of-Concept Trial. Mov Disord. 2021 Oct;36(10):2408-2412. doi: 10.1002/mds.28702. Epub 2021 Jun 30.
PubMed 34191352
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-Week, Double-blind, Placebo-controlled, Randomized, Multicenter, Crossover Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness
- ClinicalTrials.gov ID
- NCT03037203
- Acronym / sponsor ID
- JZP166-201
- Conditions
- Excessive Sleepiness, Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Posted 9 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult subjects with idiopathic PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: JZP-110, Other: PlaceboJZP-110 and Placebo |
| Arm B | Experimental | Drug: JZP-110, Other: PlaceboJZP-110 and Placebo |
| Arm C | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of idiopathic PD according to the UK PDS Brain Bank Criteria.
- Hoehn and Yahr stage 1, 2, or 3.
- Screening and Baseline ESS scores >11.
Key exclusion criteria (4 listed)
- Diagnosis of other degenerative Parkinsonian syndromes (e.g., progressive supranuclear palsy, multiple system atrophy [MSA], or dementia with Lewy bodies [DLB]).
- Usual nightly time in bed of <6 hours, including the night before the Baseline visit.
- Untreated or inadequately treated moderate to severe OSA.
- Has evidence at screening of severe cognitive impairment or has cognitive impairment that in the opinion of the investigator would prevent completion of study procedures or the ability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JZP-11075 mg, 150 mg, 300 mg | Drug | Arm A, Arm B |
| Placebo | Other | Arm A, Arm B, Arm C |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation
Time frame: Up to Day 35
1 secondary outcome
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score
Time frame: Baseline to Weeks 1, 2, 3, and 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34191352Videnovic A, Amara AW, Comella C, Schweitzer PK, Emsellem H, Liu K, Sterkel AL, Gottwald MD, Steinerman JR, Jochelson P, Zomorodi K, Hauser RA. Solriamfetol for Excessive Daytime Sleepiness in Parkinson's Disease: Phase 2 Proof-of-Concept Trial. Mov Disord. 2021 Oct;36(10):2408-2412. doi: 10.1002/mds.28702. Epub 2021 Jun 30.
- Individual participant dataSharing planned: No
Related trials for Excessive Sleepiness
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
RecruitingPhase 2/3
A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia
Idiopathic Hypersomnia, Narcolepsy Type 1
RecruitingPhase 2/3
A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
Narcolepsy Type 1, Narcolepsy Type 2
Active, not recruitingPhase 3
A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
Narcolepsy Type 1 (NT1), Narcolepsy With Cataplexy
RecruitingPhase 2
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Millie Gottwald, PharmD study director
Jazz Pharmaceuticals
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JZP-110 in people with Excessive Sleepiness and Parkinson Disease, run by Jazz Pharmaceuticals at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation (time frame: Up to Day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03037203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.