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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01130493 |
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Date of registration:
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24/05/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066
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Scientific title:
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A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson's Disease |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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110 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01130493 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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France
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Germany
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Italy
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United States
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Contacts
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Name:
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Impax Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Impax Laboratories, LLC |
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Key inclusion & exclusion criteria
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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.
Age minimum:
30 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: CLE
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Drug: IPX066
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Primary Outcome(s)
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Percentage of "OFF" Time During Waking Hours
[Time Frame: 3 days of data immediately prior to the end of each 2 week treatment period]
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Secondary Outcome(s)
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UPDRS Part II Plus Part III
[Time Frame: End of each double-blind treatment period.]
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Total "On" With No Troublesome Dyskinesia
[Time Frame: 3 days of data immediately prior to the end of each 2 week treatment period]
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Subject Preference
[Time Frame: End of Study (week 11)]
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Total "OFF" Time During Waking Hours
[Time Frame: 3 days of data immediately prior to the end of each 2 week treatment period]
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Secondary ID(s)
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IPX066-B09-06
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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