NCT00869791

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
7.8 years until next milestone

Results Posted

Study results publicly available

March 31, 2017

Completed
Last Updated

November 8, 2019

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

March 24, 2009

Results QC Date

January 25, 2016

Last Update Submit

October 25, 2019

Conditions

Parkinson's Disease

Keywords

Parkinson's

Outcome Measures

Primary Outcomes (3)

  • 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.

    For both treatment arms: Sequence 1 (IPX066, Washout, then IR CD-LD) and Sequence 2 (IR CD-LD, Washout, IPX066), blood samples for measurement of LD and CD plasma concentrations were collected pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, and 8 hours after dosing on Day 1 (referred to as Single-Dose data); and at pre-dose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing on Day 8 (referred to as Multiple-Dose data). Maximum (peak) drug concentration (Cmax in nanograms/milliliter) was estimated using Single-Dose data and Multiple-Dose data.

    Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm 2 (CD-LD IR first, washout, then IPX066)

  • 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.

    For both treatment arms: Sequence 1 (IPX066, Washout, then IR CD-LD) and Sequence 2 (IR CD-LD, Washout, IPX066), blood samples for measurement of LD and CD plasma concentrations were collected pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, and 8 hours after dosing on Day 1 (referred to as Single-Dose data); and at pre-dose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing on Day 8 (referred to as Multiple-Dose data). Time of maximum drug concentration (Tmax in hours) was estimated using Single-Dose data and Multiple-Dose data.

    Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm2 (CD-LD IR first, washout, then IPX066

  • 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.

    For both treatment arms: Sequence 1 (IPX066, Washout, then IR CD-LD) and Sequence 2 (IR CD-LD, Washout, IPX066), blood samples for measurement of LD and CD plasma concentrations were collected pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, and 8 hours after dosing on Day 1 (referred to as Single-Dose data); and at pre-dose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing on Day 8 (referred to as Multiple-Dose data). Area under the concentration-time curve for the dosing interval (AUC Tau) in hour\*nanogram/milliliter was estimated using Single-Dose data and Multiple-Dose data.

    Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm2 (CD-LD IR first, washout, then IPX066

Secondary Outcomes (4)

  • 8-Hour Efficacy Using Day 1 Tapping

    Day 1 of each treatment period - three times prior to dosing in the clinic, and at half-hour intervals through the 8-hour measurement period

  • 8-Hour Efficacy Using Day 1 Unified Parkinson's Disease Rating Scale Part III Score

    Pre dosing and at hourly intervals through the 8-hour measurement period on day 1

  • Result Summary of Day 1 Dyskinesia Evaluated by Investigator Assessment for Each Treatment Period

    Predose and then every 30 min upto 8 h after dosing on Day of 1 of each treatment period

  • "Off" Time Hours Reported by Subjects Using Parkinson's Patient Diary

    Last 3 days of each treatment period, every 30 minutes over a 24-hour day beginning at 6:00 AM

Study Arms (2)

Sequence 1

OTHER

Treatment Period 1: IPX066 - 7 days; Washout Period - 7 days; Treatment Period 2: IR CD-LD- 7 days

Drug: IPX066Drug: IR CD-LD

Sequence 2

OTHER

Treatment Period 1: IR CD-LD - 7 days; Washout period - 7 days; Treatment Period 2: IPX066- 7 days

Drug: IPX066Drug: IR CD-LD

Interventions

IPX066DRUG

experimental drug product: extended-release carbidopa-levodopa capsules

Also known as: ER CD-LD
Sequence 1Sequence 2
IR CD-LDDRUG

active comparator: immediate-release carbidopa-levodopa capsules

Also known as: immediate-release carbidopa-levodopa
Sequence 1Sequence 2

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IMPAX Laboratories

Hayward, California, 94544, United States

Location

Related Publications (1)

  • Hauser RA, Ellenbogen AL, Metman LV, Hsu A, O'Connell MJ, Modi NB, Yao HM, Kell SH, Gupta SK. Crossover comparison of IPX066 and a standard levodopa formulation in advanced Parkinson's disease. Mov Disord. 2011 Oct;26(12):2246-52. doi: 10.1002/mds.23861. Epub 2011 Jul 13.

    PMID: 21755537BACKGROUND

Related Links

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Limitations and Caveats

The limitations of this study include its relatively small size, multiple statistical testing, short study durations, and open-label design.

Results Point of Contact

Title
Michelle Landolfi, PhD. Sr. Director, Regulatory Affairs
Organization
Impax Laboratories, Inc.
Michelle.Landolfi@impaxlabs.com
(510) 240-6496

Study Officials

  • Impax Study Director

    Impax Laboratories, LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2009

First Posted

March 26, 2009

Study Start

November 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

November 8, 2019

Results First Posted

March 31, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)