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

Parkinson's Disease Clinical Trial

Official title:

A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974974
• Other study ID #: IPX066-B09-02
• Status: Completed
• Phase: Phase 3
• Start date: September 2009
• Est. completion date: March 2011

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 471
• Est. completion date: March 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• IPX066
extended-release carbidopa-levodopa capsules
• IR CD-LD
immediate-release carbidopa-levodopa tablets

Locations

Country	Name	City	State
Canada	Investigator 24	London	Ontario
Canada	Investigator 18	Ottawa	Ontario
Canada	Investigator 26	Quebec
France	Investigator 22	Dijon	Bourgogne
France	Investigator 52	Lille	NORD Pas-de-calais
France	Investigator 58	Paris	Ile-de-france
France	Investigator 32	Strasbourg Cedex	Alsace
France	Investigator 33	Toulouse	Midi-pyrenees
Germany	Investigator 23	Berlin
Germany	Investigator 28	Berlin
Germany	Investigator 67	Berlin
Germany	Investigator 72	Berlin
Germany	Investigator 30	Sachsen	Dresden
Germany	Investigator 27	Westerstede	Niedersachsen
Poland	Investigator 48	Bydgoszcz	Kujawsko-pomorskie
Poland	Investigator 34	Katowice
Poland	Investigator 37	Kraków	Malopolskie
Poland	Investigator 59	Lublin	Lubelskie
Poland	Investigator 35	Mosina	Wielkopoloskie
Poland	Investigator 54	Szczecin	Zachodniopomorskie
Poland	Investigator 36	Warszawa	Mazowieckie
Romania	Investigator 68	Brasov
Romania	Investigator 62	Bucuresti
Romania	Investigator 63	Târgu Mures
Romania	Investigator 69	Târgu-Mures	Mures
Spain	Investigator 45	Barcelona
Spain	Investigator 57	Barcelona
Spain	Investigator 70	Barcelona
Spain	Investigator 50	Madrid
Spain	Investigator 53	Madrid
Spain	Investigator 43	Terrassa	Barcelona
Ukraine	Investigator 55	Dnepropetrovsk	Dnipropetrovsk
Ukraine	Investigator 71	Donetsk
Ukraine	Investigator 44	Kharkiv
Ukraine	Investigator 66	Odessa
Ukraine	Investigator 56	Vinnitsa	Vinnytsya
Ukraine	Investigator 41	Zaporozhye
Ukraine	Investigator 47	Zaporozhye	Zaporizhzhya
United States	Investigator 25	Albany	New York
United States	Investigator 46	Augusta	Georgia
United States	Investigator 51	Aurora	Colorado
United States	Investigator 1	Bingham Farms	Michigan
United States	Investigator 17	Birmingham	Alabama
United States	Investigator 38	Boise	Idaho
United States	Investigator 64	Bradenton	Florida
United States	Investigator 14	Charleston	South Carolina
United States	Investigator 19	Chicago	Illinois
United States	Investigator 40	Chicago	Illinois
United States	Investigator 20	Cincinnati	Ohio
United States	Investigator 8	Commack	New York
United States	Investigator 16	Dallas	Texas
United States	Investigator 39	Des Moines	Iowa
United States	Investigator 11	Durham	North Carolina
United States	Investigator 61	Hollywood	Florida
United States	Investigator 13	Houston	Texas
United States	Investigator 29	Kansas City	Kansas
United States	Investigator 3	La Jolla	California
United States	Investigator 7	Little Rock	Arkansas
United States	Investigator 2	Milwaukee	Wisconsin
United States	Investigator 21	New Brunswick	New Jersey
United States	Investigator 10	New Haven	Connecticut
United States	Investigator 12	New York	New York
United States	Investigator 5	Ocala	Florida
United States	Investigator 49	Phoenix	Arizona
United States	Investigator 15	Port Charlotte	Florida
United States	Investigator 8	Port Charlotte	Florida
United States	Investigator 9	Raleigh	North Carolina
United States	Investigator 4	Saint Petersburg	Florida
United States	Investigator 31	Sunnyvale	California
United States	Investigator 65	Tacoma	Washington
United States	Investigator 42	Toledo	Ohio
United States	Investigator 6	Torrance	California
United States	Investigator 60	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Impax Laboratories, LLC

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Poland,  Romania,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of "Off" Time During Waking Hours at End of Study	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)."	22 weeks
Secondary	"Off" Time	"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)."	22 weeks
Secondary	"On" Time Without Troublesome Dyskinesia	"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."	22 weeks