A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).

Phase 3

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: IPX066; Drug: IR CD-LD

• Registration Number: NCT00974974
• Lead Sponsor: Impax Laboratories, LLC

Brief Summary

This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's disease.

Detailed Description

A randomized, double-blind, active-control, parallel-group 13-week comparison of IPX066 versus regular carbidopa-levodopa (CD-LD). Prior to randomization, subjects on a stable regular LD regimen will enter a 3-week dose-adjustment period for IR CD-LD, followed by a 6-week dose-conversion period to IPX066.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-10
• Study First Posted: 2009-09-11
• Primary Completion: 2011-01
• Study Completion: 2011-03
• Disposition First Submitted: 2013-09-27
• Disposition First Submitted QC: 2013-09-27
• Disposition First Posted: 2013-10-28
• Results First Submitted: 2015-12-08
• Results First Submitted QC: 2015-12-08
• Results First Posted: 2016-01-14
• Status Verified: 2017-01
• Last Update Submitted: 2020-08-07
• Last Update Posted: 2020-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 471

Inclusion Criteria

1. Diagnosed with idiopathic PD.

2. At least 30 years old at the time of PD diagnosis.

3. Currently being treated with IR LD (CD-LD or benserazide-LD) and on a stable regimen of IR LD for at least 4 weeks and:

   • Requiring a total daily IR LD dose of at least 400 mg
   • Having a minimum dosing frequency of four times per day.

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 or planning to take during participation in the clinical study: any controlled-release LD product, additional CD (e.g., Lodosyn®) or benserazide (e.g. Serazide®), catechol-O-methyl transferase inhibitors (e.g., entacapone and tolcapone), nonselective MAO inhibitors, apomorphine, and antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
5. Allergic to Yellow Dye #5 (tartrazine).
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. A 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 and/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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IPX066	IR CD-LD	Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
IR CD-LD	IPX066	Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
IR CD-LD	IR CD-LD	Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
IPX066	IPX066	Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.

Primary Outcome Measures

Name	Time	Method
Percentage of "Off" Time During Waking Hours at End of Study	22 weeks	Percentage of "off" time during waking hours at end of study is measured by using the Parkinson's disease diary. "Off" time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)."

Secondary Outcome Measures

Name	Time	Method
"Off" Time	22 weeks	"Off" time hours is measured by using the Parkinson's disease diary. "Off" time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)."
"On" Time Without Troublesome Dyskinesia	22 weeks	"On" time without troublesome dyskinesiais measured by using the Parkinson's disease diary. "On" time without troublesome dyskinesia describes a period when the participant experiences decreased Parkinsonian symptoms (e.g. immobility or inability to move with ease) without dyskinesia (i.e. difficulty in performing voluntary movements) that affect daily living."

Trial Locations

Locations (72)

Investigator 17; 🇺🇸 Birmingham, Alabama, United States

Investigator 49; 🇺🇸 Phoenix, Arizona, United States

Investigator 7; 🇺🇸 Little Rock, Arkansas, United States

Investigator 3; 🇺🇸 La Jolla, California, United States

Investigator 31; 🇺🇸 Sunnyvale, California, United States

Investigator 6; 🇺🇸 Torrance, California, United States

Investigator 51; 🇺🇸 Aurora, Colorado, United States

Investigator 10; 🇺🇸 New Haven, Connecticut, United States

Investigator 64; 🇺🇸 Bradenton, Florida, United States

Investigator 61; 🇺🇸 Hollywood, Florida, United States

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