A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

A Study to Assess the Pharmacokinetics and Pharmacodynamics of a Single Dose of IPX203 in Patients With Advanced Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271503
• Other study ID #: IPX203-B14-02
• Status: Completed
• Phase: Phase 2
• Start date: November 2015
• Est. completion date: August 2016

Study information

• Verified date: September 2017
• Source: Impax Laboratories, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

IPX203 contains two different drugs called levodopa and carbidopa in one capsule.

• levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease.

• carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion criteria:

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• CD-LD IR
CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
• IPX203 180 mg
IPX203 containing 45 mg carbidopa and180 mg levodopa
• IPX203 270 mg
IPX203 containing 67.5 mg carbidopa and 270 mg levodopa
• Rytary 195 mg
Rytary 48.75Mg-195Mg Extended-Release Capsule
• Rytary 145 mg
Rytary 36.25Mg-145Mg Extended-Release Capsule

Locations

Country	Name	City	State
United States	Georgia Regents University	Augusta	Georgia
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Duke University Movement Disorders Clinic	Durham	North Carolina
United States	QUEST Research Institute	Farmington Hills	Michigan
United States	The Parkinson's and Movement Disorder Institute	Fountain Valley	California
United States	Clinical Trials, Inc.	Little Rock	Arkansas
United States	Collier Neurologic Specialists	Naples	Florida
United States	Muhammad Ali Movement Disorder Center (MAMDC)	Phoenix	Arizona
United States	Premier Clinical Research	Spokane	Washington
United States	University of South Florida Parkinson's Disease and Movement Disorder Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Impax Laboratories, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with Adverse Events		Screening through end of study approximately 6 weeks per subject
Other	Maximum concentration (Cmax)		Up to 10 hours
Other	Area under the curve (AUC)		Up to 10 hours
Primary	"Off" time per the Assessment of Subject's Motor State		Up to 10 hours
Secondary	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
Secondary	Change from predose value in the number of finger-taps at each timepoint		Up to 10 hours