A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130493
• Other study ID #: IPX066-B09-06
• Status: Completed
• Phase: Phase 3
• Start date: May 2010
• Est. completion date: January 2012

Study information

• Verified date: September 2017
• Source: Impax Laboratories, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• IPX066
experimental product
• CLE
active comparator

Locations

Country	Name	City	State
France	Hôpital Gabriel Montpied-Service de Neurologie A-	Clermont-Ferrand Cedex 1
France	Service de neurologie-Hôpital de la Timone-	Marseille
Germany	Praxis für Neurologie, Psychiatrie und Psychotherapie Achim	Achim
Germany	Praxis Dres. Bitter/Schumann	Bochum
Germany	Klinikum rechts der Isar der Technischen Universität München	München
Germany	Klinik für Neurologie, Stadtroda	Stadtroda
Germany	RKU, Neurologische Klinik der Universität Ulm	Ulm
Italy	Casa di Cura Villa Margherita	Arcugnano
Italy	San Raffaele Cassino, San Raffaele Cassino,	Cassino
Italy	Dipartimento di Oncologia e Neuroscienze, Università G. D'Annunzio	Chieti
Italy	Ospedale della Misericordia	Grosseto
Italy	IRCCS San Raffaele Pisana	Roma
United States	Quest Research Institute	Bingham Farms	Michigan
United States	University Neurology, Inc	Cincinnati	Ohio
United States	Parkinson's Disease and Movement Disorders Center of Long Island	Commack	New York
United States	Margolin Brain Institute	Fresno	California
United States	Kingston Neurological Associates	Kingston	New York
United States	Booth Gardner Parkinson's Care Center	Kirkland	Washington
United States	University Health Systems	Las Vegas	Nevada
United States	UM Movement Disorders Center	Miami	Florida
United States	Charlotte Neurological Services	Port Charlotte	Florida
United States	The Parkinson's Institute in Sunnyvale	Sunnyvale	California
United States	USF Parkinson's and Movement Disorders Center	Tampa	Florida
United States	Sentara Neurological Associates	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Impax Laboratories, LLC

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of "OFF" Time During Waking Hours	Using a Parkinson's disease diary, subjects recorded a state of "asleep", "OFF", "ON without dyskinesia," "ON with non-troublesome dyskinesia," or "ON with troublesome dyskinesia" every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.; Mean percentage of "OFF" Time During Waking Hours was calculated. "Off" Time is Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness.	3 days of data immediately prior to the end of each 2 week treatment period
Secondary	Total "OFF" Time During Waking Hours	Using a Parkinson's disease diary, subjects recorded a state of "asleep", "OFF", "ON without dyskinesia," "ON with non-troublesome dyskinesia," or "ON with troublesome dyskinesia" every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.; Mean Total "Off" Time During Waking Hours was calculated. "Off" Time is Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness.	3 days of data immediately prior to the end of each 2 week treatment period
Secondary	Total "On" With No Troublesome Dyskinesia	Using a Parkinson's disease diary, subjects recorded a state of "asleep", "OFF", "ON without dyskinesia," "ON with non-troublesome dyskinesia," or "ON with troublesome dyskinesia" every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.; Mean Total "On" with No Troublesome Dyskinesia was calculated. "On" Time is when medication is providing benefit with regard to mobility, slowness, and stiffness.	3 days of data immediately prior to the end of each 2 week treatment period
Secondary	UPDRS Part II Plus Part III	Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). Part II consists of 14 questions, each ranges from 0 (Normal/None) - 4 (Worst) with a total score of 0 - 72. Part III consists of 27 questions, each ranges from 0 (Normal/None) - 4 (Worst) with a total score of 0 - 108.; The UPDRS Part II Plus Part III scores ranged from 0 (no problems with daily living or mobility) to 180 (severe problems with daily living and mobility.	End of each double-blind treatment period.
Secondary	Subject Preference	Subjects who completed both treatments were asked to indicate a preference for Treatment Period 1 or Treatment Period 2 or no preference. Preferences for a particular treatment period were mapped to the associated treatment and reported.	End of Study (week 11)