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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

Primary Purpose

Excessive Sleepiness, Parkinson Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
JZP-110
Placebo
Sponsored by
Jazz Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Excessive Sleepiness

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of idiopathic PD according to the UK PDS Brain Bank Criteria.
  2. Hoehn and Yahr stage 1, 2, or 3.
  3. Screening and Baseline ESS scores >11.

Exclusion Criteria:

  1. Diagnosis of other degenerative Parkinsonian syndromes (e.g., progressive supranuclear palsy, multiple system atrophy [MSA], or dementia with Lewy bodies [DLB]).
  2. Usual nightly time in bed of <6 hours, including the night before the Baseline visit.
  3. Untreated or inadequately treated moderate to severe OSA.
  4. 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.

Sites / Locations

  • Southern California Institute For Respiratory Diseases, Inc.
  • Pacific Research Network, Inc
  • Alpine Clinical Research Center
  • Rocky Mountain Movement Disorders Center, PC
  • Parkinson's Disease and Movement Disorders Center of Boca Raton
  • PAB Clinical Research
  • MD Clinical
  • QPS MRA (Miami Research Associates)
  • Bioclinica Research
  • USF Health Byrd Institute
  • Rush University Medical Center
  • University of Kansas Medical Center Research Institute, Inc.
  • Center for Sleep & Wake Disorders
  • QUEST Research Institute
  • Clinical Neurophysiology Services, P.C.
  • Henry Ford Medical Center - West Bloomfield
  • St. Lukes Hospital Medical Center
  • Montefiore Sleep-Wake Disorders Center
  • Strong Sleep Disorders Center
  • Lynn Health Science Institute
  • Parkinson's Disease Research Unit - Thomas Jefferson University
  • SleepMed of South Carolina
  • Villages at Vanderbilt
  • Evergreen Hospital Medical Center
  • Premier Clinical Research - Sherman

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Arm A

Arm B

Arm C

Arm Description

JZP-110 and Placebo

JZP-110 and Placebo

Placebo

Outcomes

Primary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation

Secondary Outcome Measures

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.

Full Information

First Posted
January 23, 2017
Last Updated
January 3, 2020
Sponsor
Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03037203
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jazz Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Excessive Sleepiness, Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
JZP-110 and Placebo
Arm Title
Arm B
Arm Type
Experimental
Arm Description
JZP-110 and Placebo
Arm Title
Arm C
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
JZP-110
Intervention Description
75 mg, 150 mg, 300 mg
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation
Time Frame
Up to Day 35
Secondary Outcome Measure Information:
Title
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score
Description
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.
Time Frame
Baseline to Weeks 1, 2, 3, and 4
Other Pre-specified Outcome Measures:
Title
Change From Baseline in the Mean Sleep Latency Time (in Minutes) on the Maintenance of Wakefulness Test (MWT)
Description
Change from Baseline mean sleep latency (in minutes) on the MWT 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 MWT is the standard objective measure of an individual's ability to remain awake during the daytime in a darkened, quiet environment. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicated greater ability to stay awake.
Time Frame
Baseline to Weeks 1, 2, 3, and 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Millie Gottwald, PharmD
Organizational Affiliation
Jazz Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Southern California Institute For Respiratory Diseases, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pacific Research Network, Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Alpine Clinical Research Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
Rocky Mountain Movement Disorders Center, PC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Parkinson's Disease and Movement Disorders Center of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
PAB Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
QPS MRA (Miami Research Associates)
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Bioclinica Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
USF Health Byrd Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Kansas Medical Center Research Institute, Inc.
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Center for Sleep & Wake Disorders
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
QUEST Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Clinical Neurophysiology Services, P.C.
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48314
Country
United States
Facility Name
Henry Ford Medical Center - West Bloomfield
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
St. Lukes Hospital Medical Center
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Montefiore Sleep-Wake Disorders Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Strong Sleep Disorders Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Parkinson's Disease Research Unit - Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
SleepMed of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Villages at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Evergreen Hospital Medical Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Premier Clinical Research - Sherman
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34191352
Citation
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.
Results Reference
derived

Learn more about this trial

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

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