Phase 3
Completed N=43
Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study
Source: ClinicalTrials.gov NCT01411137 ↗Enrolled (actual)
43
Serious AEs
13.9%
Results posted
Apr 2017
Primary outcomePrimary: Patient Global Impression (PGI) — 5.2; 5.4; 5.3; 2.8 units on a scale
◆ Published Evidence
Emerging
8citations · ~1 / year
Conversion to carbidopa and levodopa extended-release (IPX066) followed by its extended use in patients previously taking controlled-release carbidopa-levodopa for advanced Parkinson's disease.
Summary
The study had three distinct parts and is described as follows:
Part 1:
* To evaluate the dose conversion from CD-LD ER taken alone or in combination with CD-LD IR to IPX066 in subjects with advanced PD
* To evaluate the utility of the Objective Parkinson's Disease Measurement (OPDM), an exploratory computer-based system, in assessing dexterity and mobility in a subset of PD subjects.
Part 2:
• To evaluate the long-term safety and clinical utility of IPX066 under open-label conditions in eligible subjects who successfully completed Part 1 of the study.
Part 3:
• To further evaluate the long-term safety of IPX066 in eligible subjects who successfully completed Part 2.
Linked Publications
-
Conversion to carbidopa and levodopa extended-release (IPX066) followed by its extended use in patients previously taking controlled-release carbidopa-levodopa for advanced Parkinson's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Global Impression (PGI) |
5.2; 5.4; 5.3; 2.8 | — |
| PRIMARY Clinical Global Impression (CGI) |
5.5; 5.7; 5.6; 3.7 | — |
| PRIMARY Parkinson's Disease Questionnaire-8 (PDQ-8) |
9.6; 8.1; 8.5; 9.0; 11.8 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with idiopathic PD without any known cause for Parkinsonism.
- At least 30 years old at the time of PD diagnosis.
- Currently being treated with:
- an LD dosing frequency of at least four times a day
- at least one dose of CD-LD ER daily
- requiring a total daily LD dose of at least 400 mg
- stable regimen for at least 4 weeks prior to Screening
- Concomitant therapy with amantadine, anticholinergics, selective monoamine oxidase (MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists is allowed as long as the doses and regimens have been stable for at least 4 weeks prior to Screening and the therapy is intended to be constant throughout the course of the study.
- Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study.
Exclusion Criteria
- Pregnant or breastfeeding
- Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.
- Nonresponsive to LD therapy.
- Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation.
- Planning to take during participation in the clinical study: any controlled-release LD product, additional CD or benserazide, entacapone or tolcapone, nonselective MAO inhibitors, or antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
- Any evidence of suicidal behavior within 6 months of entering the study.
- Allergic or hypersensitive to to CD, LD, entacapone, riboflavin, Yellow Dye #5 (tartrazine), citrus fruit or grape juice.
- History of or currently active psychosis.
- Active or history of peptic ulcers or surgical procedure of the stomach, the small intestine or the large intestine.
- Active or history of narrow-angle glaucoma.
- History of malignant melanoma or a suspicious undiagnosed skin lesion.
- History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome and/or nontraumatic rhabdomyolysis.
- Abnormal kidney function
- Severe hepatic impairment.
- Received any investigational medications during the 4 weeks prior to Screening.
- Previously enrolled in IPX066 studies.
Data sourced from ClinicalTrials.gov (NCT01411137) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.