Phase 2
Completed N=27
A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa
Source: ClinicalTrials.gov NCT00869791 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Pharmacokinetics Measurements to Determine Cmax for Carbidopa (CD) and Levodopa (LD) Plasma Concentrations From Samples Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Both Treatment Arms. — 238.852; 146.848; 313.222; 167.515 nanogram/milliliter
Summary
This study evaluated the pharmacokinetics, motor effects, and assessed the safety of IPX066 compared with an immediate-release cabridopa-levodopa formulation in subjects with advanced Parkinson's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics Measurements to Determine Cmax for Carbidopa (CD) and Levodopa (LD) Plasma Concentrations From Samples Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Both Treatment Arms. |
238.852; 146.848; 313.222; 167.515; 3000.000; 2356.444 | — |
| PRIMARY Pharmacokinetics Measurements to Determine Tmax for Levodopa and Carbidopa Plasma Concentrations From Samples Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Both Treatment Arms. |
2.944; 2.296; 3.815; 5.685; 2.037; 0.870 | — |
| PRIMARY Pharmacokinetics Measurements to Determine Area Under the Concentration-time Curve for the Dosing Interval for LD and CD Concentrations From Blood Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Treatment Arms. |
917.067; 401.694; 1344.436; 449.584; 10902.194; 3881.298 | — |
| SECONDARY 8-Hour Efficacy Using Day 1 Tapping |
4.74; 2.98 | — |
| SECONDARY 8-Hour Efficacy Using Day 1 Unified Parkinson's Disease Rating Scale Part III Score |
21.6; 25.5 | — |
| SECONDARY Result Summary of Day 1 Dyskinesia Evaluated by Investigator Assessment for Each Treatment Period |
1.90; 4.44; 2.94; 2.36; 2.62; 0.90 | — |
| SECONDARY "Off" Time Hours Reported by Subjects Using Parkinson's Patient Diary |
3.83; 5.83 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female diagnosed with idiopathic PD, without any known cause for Parkinsonism.
- If female and of childbearing potential, subject should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier). The subject must agree to take every precaution to ensure that pregnancy will not occur during the study.
- At least 30 years old at the time of diagnosis of PD.
- Mini Mental State Examination (MMSE) ≥ 26 at Screening Visit.
- A responder to LD and currently being chronically treated with stable dosage of commercially available standard, orally disintegrating, or controlled-release CD LD for at least 1 month.
- Must have predictable fluctuations between "on" and "off" states.
- Hoehn and Yahr Stage I-IV when "on".
- Able to provide informed consent and willing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization.
- Able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections.
Exclusion Criteria
- Pregnant or breastfeeding.
- Diagnosed with atypical parkinsonism.
- History, physical findings or laboratory results suggesting a diagnosis other than PD.
- Allergic or nonresponsive to previous CD-LD therapy.
- Any medical (e.g., liver or kidney impairment, peptic ulcer) or condition/history that, in the Investigator's opinion, may jeopardize the subject's safety.
- Exposure to any investigational agent within 30 days prior to Visit 1.
- Donated blood or plasma within 28 days.
- Had prior functional neurosurgical treatment for PD (ablation or Deep Brain Stimulation).
Data sourced from ClinicalTrials.gov (NCT00869791). 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.