A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).
This study has been completed.
Sponsor:
IMPAX Laboratories, Inc.
Information provided by:
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00974974
First received: September 10, 2009
Last updated: March 10, 2011
Last verified: March 2011
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Purpose
This is a study to evaluate the safety and efficacy of IPX066 in Advanced Parkinson's Disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: IPX066 Drug: regular carbidopa-levodopa |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease |
Resource links provided by NLM:
Further study details as provided by IMPAX Laboratories, Inc.:
Primary Outcome Measures:
- Parkinson's Disease Patient Diary [ Time Frame: Weeks 1-22 ] [ Designated as safety issue: No ]
| Enrollment: | 471 |
| Study Start Date: | September 2009 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: IPX066
IPX066
|
Drug: IPX066
IPX066
|
|
Active Comparator: regular Carbidopa-Levodopa
regular Carbidopa-Levodopa
|
Drug: regular carbidopa-levodopa
regular carbidopa-levodopa
|
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 regular CD-LD, followed by a 6-week Dose-Conversion period to IPX066.
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosed with idiopathic PD.
- At least 30 years old at the time of PD diagnosis.
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.
- Able to differentiate "on" state from "off" state.
- Have predictable "off" periods.
- 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.
- Agrees to use a medically acceptable method of contraception throughout the study and for 1 month afterward.
Exclusion Criteria:
- Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.
- Nonresponsive to LD therapy.
- Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation.
- 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.
- Allergic to Yellow Dye #5 (tartrazine).
- History of or currently active psychosis.
- Active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedures that would interfere with LD absorption.
- Active or history of narrow-angle glaucoma.
- A history of malignant melanoma or a suspicious undiagnosed skin lesion.
- History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome and/or nontraumatic rhabdomyolysis.
- Received any investigational medications during the 4 weeks prior to Screening.
- Unable to swallow large pills (e.g., large vitamin pills).
- Pregnant or breastfeeding.
- Subjects who are unable to complete a symptom diary.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974974
Show 73 Study Locations
Show 73 Study LocationsSponsors and Collaborators
IMPAX Laboratories, Inc.
Investigators
| Study Director: | Impax Study Director | Impax Pharmaceuticals, a division of Impx Laboratories. |
More Information
No publications provided
| Responsible Party: | Jeff Mulchahey, PhD/Sr. Director Regualtory Affairs, IMPAX Laboratories |
| ClinicalTrials.gov Identifier: | NCT00974974 History of Changes |
| Other Study ID Numbers: | IPX066-B09-02 |
| Study First Received: | September 10, 2009 |
| Last Updated: | March 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by IMPAX Laboratories, Inc.:
|
Parkinson's Disease |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Carbidopa Levodopa Carbidopa, levodopa drug combination Antiparkinson Agents |
Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Physiological Effects of Drugs Dopamine Agonists Adjuvants, Immunologic Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013