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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02271503
• Date of registration: 13/10/2014
• Prospective Registration: Yes
• Primary sponsor: Impax Laboratories, LLC
• Public title: A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease
• Scientific title: A Study to Assess the Pharmacokinetics and Pharmacodynamics of a Single Dose of IPX203 in Patients With Advanced Parkinson's Disease
• Date of first enrolment: November 2015
• Target sample size: 26
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02271503
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Impax Study Director
• Affiliation: Impax Laboratories, LLC

Key inclusion & exclusion criteria

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.



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Rytary 145 mg

Drug: CD-LD IR

Drug: IPX203 180 mg

Drug: IPX203 270 mg

Drug: Rytary 195 mg

Primary Outcome(s)

"Off" time per the Assessment of Subject's Motor State [Time Frame: Up to 10 hours]

Secondary Outcome(s)

Change from predose value in the number of finger-taps at each timepoint [Time Frame: Up to 10 hours]

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 [Time Frame: Up to 10 hours]

Secondary ID(s)

IPX203-B14-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors