Clinical trial NCT01130493: A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066
Official title: A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Lead sponsor: Impax Laboratories, LLC
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 110
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.

Detailed description: This is a randomized, double-blind, double-dummy, 2 treatment, 2-period crossover study followed by an open-label extension study period.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with idiopathic Parkinson's Disease (PD).
2. At least 30 years old at the time of PD diagnosis.
3. Currently being treated with carbidopa/levodopa/entacapone (CLE) and on a stable regimen of conventional LD for at least 4 weeks and:

   * Requiring a total daily levodopa (LD) dose of at least 400 mg
   * Having a minimum dosing frequency of four times per day.
   * Individual CD-LD or CLE doses that contain an LD dose which is a multiple of 50 mg.
4. Able to differentiate "on" state from "off" state.
5. Have predictable "off" periods.
6. Amantadine, anticholinergics, selective monoamine oxidase (MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists are 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.
7. Agrees to use a medically acceptable method of contraception throughout the study and for 1 month afterward.

Exclusion Criteria:

1. Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.
2. Nonresponsive to LD therapy.
3. Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation.
4. Received within 4 weeks of Screening or planning to take during participation in the clinical study: any controlled-release LD product, tolcapone, apomorphine, nonselective MAO inhibitors, or antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
5. Allergy or hypersensitivity to CD, LD, entacapone, riboflavin, Yellow Dye #5 (tartrazine), citrus fruit or grape juice.
6. History of or currently active psychosis.
7. Active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedures that would interfere with LD absorption.
8. Active or history of narrow-angle glaucoma.
9. History of malignant melanoma or a suspicious undiagnosed skin lesion.
10. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome or nontraumatic rhabdomyolysis.
11. Received any investigational medications during the 4 weeks prior to Screening.
12. Unable to swallow large pills (e.g., large vitamin pills).
13. Pregnant or breastfeeding.
14. Subjects who are unable to complete a symptom diary.

Primary outcomes:
measure: Percentage of "OFF" Time During Waking Hours
timeFrame: 3 days of data immediately prior to the end of each 2 week treatment period
Secondary outcomes:
measure: Total "OFF" Time During Waking Hours
timeFrame: 3 days of data immediately prior to the end of each 2 week treatment period
measure: Total "On" With No Troublesome Dyskinesia
timeFrame: 3 days of data immediately prior to the end of each 2 week treatment period
measure: UPDRS Part II Plus Part III
timeFrame: End of each double-blind treatment period.
measure: Subject Preference
timeFrame: End of Study (week 11)
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Margolin Brain Institute
state: California
city: Sunnyvale
country: United States
facility: The Parkinson's Institute in Sunnyvale
state: California
city: Miami
country: United States
facility: UM Movement Disorders Center
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Neurological Services
state: Florida
city: Tampa
country: United States
facility: USF Parkinson's and Movement Disorders Center
state: Florida
city: Bingham Farms
country: United States
facility: Quest Research Institute
state: Michigan
city: Las Vegas
country: United States
facility: University Health Systems
state: Nevada
city: Commack
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Long Island
state: New York
city: Kingston
country: United States
facility: Kingston Neurological Associates
state: New York
city: Cincinnati
country: United States
facility: University Neurology, Inc
state: Ohio
city: Virginia Beach
country: United States
facility: Sentara Neurological Associates
state: Virginia
city: Kirkland
country: United States
facility: Booth Gardner Parkinson's Care Center
state: Washington
city: Clermont-Ferrand Cedex 1
country: France
facility: Hôpital Gabriel Montpied-Service de Neurologie A-
city: Marseille
country: France
facility: Service de neurologie-Hôpital de la Timone-
city: Achim
country: Germany
facility: Praxis für Neurologie, Psychiatrie und Psychotherapie Achim
city: Bochum
country: Germany
facility: Praxis Dres. Bitter/Schumann
city: München
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München
city: Stadtroda
country: Germany
facility: Klinik für Neurologie, Stadtroda
city: Ulm
country: Germany
facility: RKU, Neurologische Klinik der Universität Ulm
city: Arcugnano
country: Italy
facility: Casa di Cura Villa Margherita
city: Cassino
country: Italy
facility: San Raffaele Cassino, San Raffaele Cassino,
city: Chieti
country: Italy
facility: Dipartimento di Oncologia e Neuroscienze, Università G. D'Annunzio
city: Grosseto
country: Italy
facility: Ospedale della Misericordia
city: Roma
country: Italy
facility: IRCCS San Raffaele Pisana
Study officials:
affiliation: Impax Laboratories, LLC
name: Impax Study Director
role: STUDY_DIRECTOR
References:
citation: Morgan JC, Dhall R, Rubens R, Khanna S, Gupta S. Dosing Patterns during Conversion to IPX066, Extended-Release Carbidopa-Levodopa (ER CD-LD), in Parkinson's Disease with Motor Fluctuations. Parkinsons Dis. 2018 Oct 22;2018:9763057. doi: 10.1155/2018/9763057. eCollection 2018.