NCT02271503

Brief Summary

This is a randomized, open-label, rater-blinded, multicenter, 3-treatment, 3 period, single-dose crossover study. Approximately 51 qualified immediate-release (IR) CD-LD-experienced advanced Parkinson's disease patients will be randomized to 1 of 3 dosing sequences. Objectives:

  • Assess the pharmacodynamics and pharmacokinetics (PK) of IPX203 (carbidopa and levodopa) in subjects with advanced Parkinson's disease.
  • Characterize the safety of IPX203 in subjects with advanced Parkinson's disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
1 year until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 6, 2019

Status Verified

September 1, 2017

Enrollment Period

9 months

First QC Date

October 13, 2014

Last Update Submit

October 25, 2019

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • "Off" time per the Assessment of Subject's Motor State

    Up to 10 hours

Secondary Outcomes (2)

  • Duration of effect estimated using the timepoint at which an improvement of at least 4 points in the MDS-UPDRS Part III score from predose is first observed and continuing until the timepoint at which the improvement is no longer observed

    Up to 10 hours

  • Change from predose value in the number of finger-taps at each timepoint

    Up to 10 hours

Other Outcomes (3)

  • Number of Participants with Adverse Events

    Screening through end of study approximately 6 weeks per subject

  • Maximum concentration (Cmax)

    Up to 10 hours

  • Area under the curve (AUC)

    Up to 10 hours

Study Arms (3)

Sequence 1

OTHER

Subject received a single dose of IPX203 180 mg and/or IPX203 270mg in Period 1, a single dose of CD-LD IR in Period 2, and a single dose of Rytary 145 mg and/or Rytary 195 mg in Period 3.

Drug: CD-LD IRDrug: IPX203 180 mgDrug: IPX203 270 mgDrug: Rytary 195 mgDrug: Rytary 145 mg

Sequence 2

OTHER

Subject received a single dose of a single dose of CD-LD IR in Period 1, a single dose of Rytary 145 mg and/or Rytary 195 mg in Period 2, and a single dose of IPX203 180 mg and/or IPX203 270mg in Period 3.

Drug: CD-LD IRDrug: IPX203 180 mgDrug: IPX203 270 mgDrug: Rytary 195 mgDrug: Rytary 145 mg

Sequence 3

OTHER

Subject received a single dose of a single dose of Rytary 145 mg and/or Rytary 195 mg in Period 1, a single dose of IPX203 180 mg and/or IPX203 270mg in Period 2, and a single dose of CD-LD IR in Period 3.

Drug: CD-LD IRDrug: IPX203 180 mgDrug: IPX203 270 mgDrug: Rytary 195 mgDrug: Rytary 145 mg

Interventions

CD-LD IRDRUG

CD-LD IR containing 25 mg carbidopa and 100 mg levodopa

Also known as: Sinemet
Sequence 1Sequence 2Sequence 3
IPX203 180 mgDRUG

IPX203 containing 45 mg carbidopa and180 mg levodopa

Also known as: CD-LD ER 180 mg
Sequence 1Sequence 2Sequence 3
IPX203 270 mgDRUG

IPX203 containing 67.5 mg carbidopa and 270 mg levodopa

Also known as: CD-LD ER 270 mg
Sequence 1Sequence 2Sequence 3
Rytary 195 mgDRUG

Rytary 48.75Mg-195Mg Extended-Release Capsule

Sequence 1Sequence 2Sequence 3
Rytary 145 mgDRUG

Rytary 36.25Mg-145Mg Extended-Release Capsule

Sequence 1Sequence 2Sequence 3

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects diagnosed with idiopathic PD with motor complications, who are currently being treated chronically with stable regimens of CD-LD.
  • Requiring at least 400 mg but not more than 1600 mg LD per day during the waking hours; and at least 100 mg but not more than 250 mg LD from IR CD-LD for the first morning dose.
  • Dosing frequency of IR CD-LD of at least 4 times daily excluding nighttime dosing.
  • Have an average of at least 2 hours per day "off" time during the waking hours and at least 1 hour "off" time per day, based on the PD diary collected for 3 consecutive days prior to Visit 1.

You may not qualify if:

  • Have used first morning dose of controlled-release (CR) CD-LD or Rytary for at least 4 weeks prior to Visit 1.
  • Female subjects who are currently breastfeeding or lactating.
  • Had prior functional neurosurgical treatment for PD (ablation or deep brain stimulation) or if such procedure(s) are planned or anticipated during the study period.
  • Allergic to study drugs
  • History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy or small-bowel resection.
  • History of peptic ulcer disease or upper gastrointestinal hemorrhage.
  • History of narrow angle glaucoma.
  • History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias; neuroleptic malignant syndrome; or nontraumatic rhabdomyolysis.
  • History of psychosis.
  • Employees or family members of the Investigator, study site, or Sponsor.
  • Subjects who, in the opinion of the clinical investigator, should not participate in the study.
  • Based on clinical assessment, subject does not adequately comprehend the terminology needed to complete the PD diary.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Muhammad Ali Movement Disorder Center (MAMDC)

Phoenix, Arizona, 85013, United States

Location

Clinical Trials, Inc.

Little Rock, Arkansas, 72205, United States

Location

The Parkinson's and Movement Disorder Institute

Fountain Valley, California, 92708, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Collier Neurologic Specialists

Naples, Florida, 34102, United States

Location

University of South Florida Parkinson's Disease and Movement Disorder Center

Tampa, Florida, 33613, United States

Location

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

QUEST Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Duke University Movement Disorders Clinic

Durham, North Carolina, 27705, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Impax Study Director

    Impax Laboratories, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2014

First Posted

October 22, 2014

Study Start

November 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 6, 2019

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

US(11)