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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01411137 |
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Date of registration:
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04/08/2011 |
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Primary sponsor: |
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Public title:
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Carbidopa-Levodopa Extended-Release (CD-LD ER) Alone or in Combination With Carbidopa-Levodopa Immediate Release (IR) to IPX066 Followed by Extension Safety Study of IPX066 in Subjects With Advanced Parkinson's Disease
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Scientific title:
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An Open Label Conversion Study of Carbidopa-Levodopa Extended-Release (CD-LD ER) Taken Alone or in Combination With Carbidopa-Levodopa Immediate Release (IR) to IPX066 Followed by an Open-Label Extension Safety Study of IPX066 in Subjects With Advanced Parkinson's Disease |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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40 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01411137 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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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 Pharmaceuticals Division (Impax) , a Division of Impax Laboratories Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Diagnosed with idiopathic PD without any known cause for Parkinsonism.
2. At least 30 years old at the time of PD diagnosis.
3. Currently being treated with:
- an LD dosing frequency of at least four times a day
- at least one dose of CD-LD ER daily
- requiring a total daily LD dose of at least 400 mg
- stable regimen for at least 4 weeks prior to Screening
4. Concomitant therapy with amantadine, anticholinergics, selective monoamine oxidase
(MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists is
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.
5. Agrees to use a medically acceptable method of contraception throughout the study and
for 1 month after completing the study.
Exclusion Criteria:
1. Pregnant or breastfeeding
2. Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.
3. Nonresponsive to LD therapy.
4. Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain
stimulation) or if such procedures are anticipated during study participation.
5. Planning to take during participation in the clinical study: any controlled-release
LD product, additional CD or benserazide, entacapone or tolcapone, nonselective MAO
inhibitors, or antipsychotics including neuroleptic agents for the purpose of
treating psychosis or bipolar disorder.
6. Any evidence of suicidal behavior within 6 months of entering the study.
7. Allergic or hypersensitive to to CD, LD, entacapone, riboflavin, Yellow Dye #5
(tartrazine), citrus fruit or grape juice.
8. History of or currently active psychosis.
9. Active or history of peptic ulcers or surgical procedure of the stomach, the small
intestine or the large intestine.
10. Active or history of narrow-angle glaucoma.
11. History of malignant melanoma or a suspicious undiagnosed skin lesion.
12. History of myocardial infarction with residual atrial, nodal, or ventricular
arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome
and/or nontraumatic rhabdomyolysis.
13. Abnormal kidney function
14. Severe hepatic impairment.
15. Received any investigational medications during the 4 weeks prior to Screening.
16. Previously enrolled in IPX066 studies.
Age minimum:
30 Years
Age maximum:
N/A
Gender:
Both
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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: IPX066
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Primary Outcome(s)
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Clinical Global Impression
[Time Frame: 6 months]
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Parkinson's Disease Questionnaire- 8 (PDQ-8)
[Time Frame: 6 months]
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Patient Global Impression
[Time Frame: 6 months]
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Secondary ID(s)
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IPX066-B11-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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