Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03007888
Other study ID # IPX203-B16-01
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 14, 2016
Est. completion date August 1, 2017

Study information

Verified date February 2022
Source Impax Laboratories, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary Objective: To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD). Secondary Objectives: To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD. To compare the efficacy of IPX203 with IR CD-LD following multiple doses. To evaluate the safety of IPX203.


Description:

IPX203 is an investigational product containing CD-LD. IPX203-B16-01 Study Design: A randomized, open-label, rater-blinded, multicenter, 2-treatment, 2-period, multiple-dose crossover study. Approximately 30 qualified IR CD-LD-experienced advanced PD subjects will be randomized. The study duration will be approximately 8 weeks, including the screening period.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date August 1, 2017
Est. primary completion date August 1, 2017
Accepts healthy volunteers No
Gender All
Age group 40 Years to 100 Years
Eligibility Eligibility will be determined at screening and Visit 1 of the study. Inclusion Criteria: - Diagnosed with idiopathic PD at age = 40 years who are being chronically treated with stable regimens of CD-LD but experiencing motor complications. - Hoehn and Yahr Stages 2, 3, or 4 - Montreal Cognitive Assessment (MoCA) score = 24 at Screening Visit in "on" state. - For the 4 weeks prior to the Screening, the subject experiences daily "wearing-off" episodes with periods of bradykinesia and rigidity and experiences an "off" state upon awakening on most mornings by history. - Responsive to CD-LD therapy and currently being treated on a stable regimen with CD-LD for at least 4 weeks prior to Visit 1 - Typically experiences an "on" response with the first dose of IR CD-LD of the day (by subject history). - By history, efficacy of the first morning dose of IR CD-LD lasts less than 4 hours Exclusion Criteria: - History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy or proximal small-bowel resection. - Liver enzyme values = 2.5 x the upper limit of normal; or history of severe hepatic impairment. - History of drug or alcohol abuse within the 12 months prior to Screening. - Received within 4 weeks of Visit 1 or planning to take during participation in the clinical study: any doses of a controlled-release (CR) LD apart from a single daily bedtime dose or any doses of Rytary, additional CD (eg, Lodosyn) or benserazide (eg, Serazide), or catechol-O-methyl transferase inhibitors (entacapone or tolcapone) or medications containing these inhibitors (Stalevo). Received within 4 weeks of Visit 1 or planning to take during participation in the clinical study: nonselective monoamine oxidase (MAO) inhibitors, apomorphine, or dopaminergic blocking agents including antiemetics. - History of psychosis within the past 10 years. - Treatment with any dopamine antagonist antipsychotics for the purposes of psychosis or bipolar disorder within the last 2 years. - Based on clinical assessment, subject does not adequately comprehend the terminology needed to complete the PD Diary.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sinemet
Immediate Release Tablet containing carbidopa-levodopa flexible dosing
IPX203
Extended Release capsules containing carbidopa-levodopa flexible dosing

Locations

Country Name City State
United States Investigator 106 Boca Raton Florida
United States Investigator 109 Cleveland Ohio
United States Site 103 Durham North Carolina
United States Investigator 101 Farmington Hills Michigan
United States Site 115 Kirkland Washington
United States Investigator 110 Little Rock Arkansas
United States Site 114 Little Rock Arkansas
United States Investigator 112 Naples Florida
United States Investigator 113 Port Charlotte Florida
United States Investigator 104 Spokane Washington
United States Site 108 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
Primary Levodopa Cmax Following First Dose on Day 1 Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose Day 1
Primary Levodopa Tmax Following First Dose on Day 1 Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose Day 1
Primary Levodopa t1/2 Following First Dose on Day 1 Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose Day 1
Primary Levodopa AUCt Following First Dose on Day 1 Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose Day 1
Primary Levodopa AUCinf Following First Dose on Day 1 Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose Day 1
Primary Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1 Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose Day 1
Primary Carbidopa Cmax Following First Dose on Day 1 Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose Day 1
Primary Carbidopa Tmax Following First Dose on Day 1 Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose Day 1
Primary Carbidopa t1/2 Following First Dose on Day 1 Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose Day 1
Primary Carbidopa AUCt Following First Dose on Day 1 Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose Day 1
Primary Carbidopa AUCinf Following First Dose on Day 1 Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose Day 1
Primary Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1 Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose Day 1
Primary Levodopa Cmax Following First Dose on Day 15 Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose. Day 15
Primary Levodopa Tmax Following First Dose on Day 15 Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose. Day 15
Primary Levodopa AUCtau Following First Dose on Day 15 Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose. Day 15
Primary Carbidopa Cmax Following First Dose on Day 15 Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose. Day 15
Primary Carbidopa Tmax Following First Dose on Day 15 Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose. Day 15
Primary Carbidopa AUCtau Following First Dose on Day 15 Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose. Day 15
See also
  Status Clinical Trial Phase
Recruiting NCT02154724 - Clinical Study for Adaptive Deep Brain Stimulation (aDBS)Controlled by Intracerebral Activity in Parkinson's Disease N/A
Completed NCT02549092 - A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD) Phase 3
Completed NCT01960842 - A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian Medications Phase 3
Completed NCT01723904 - A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease Phase 3
Completed NCT01479127 - Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease Phase 2
Completed NCT00660673 - Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease Phase 3
Active, not recruiting NCT04802733 - Phase 1 Safety and Tolerability Study of MSK-DA01 Cell Therapy for Advanced Parkinson's Disease Phase 1
Completed NCT01736176 - A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's Disease Phase 3
Completed NCT02082249 - An Extension Study to Assess the Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medications Phase 3
Completed NCT02611713 - Observational Study Evaluating Long-Term Effectiveness of Duodopa/Duopa in Patients With Advanced Parkinson's Disease
Terminated NCT01536015 - Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction Phase 3
Completed NCT00357994 - Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Phase 3
Completed NCT00335153 - Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease Phase 3
Recruiting NCT06195124 - A Study on the Safety and Tolerability of RGL-193 in Patients With Advanced Parkinson's Disease Early Phase 1
Completed NCT00660387 - Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Phase 3