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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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
Address: 
Telephone:
Email:
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: Rytary 195 mg
Drug: IPX203 270 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
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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