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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: |
NCT00279825 |
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Date of registration:
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18/01/2006 |
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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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Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Compare IPX054 200 mg and 250 mg to CD-LD IR 200 (2x100) mg Tablets and CD-LD CR 200 mg Tablet in Subjects With Parkinson's Disease |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00279825 |
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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: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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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 Laboratories, LLC |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosed with idiopathic Parkinson's disease.
- Currently being treated with immediate-release or controlled-release
carbidopa-levodopa and not requiring more than 200 mg levodopa per dose.
- Must experience "wearing OFF" between doses of medication.
Exclusion Criteria:
- Diagnosed with atypical parkinsonism.
- Allergic or non-responsive to previous carbidopa-levodopa therapy.
- Active or history of narrow-angle or wide-angle glaucoma.
- History of seizure or epilepsy, or is currently taking an anti-convulsant for
treatment of seizures.
- Treatment with any neuroleptic agent, including atypical neuroleptics, within the
previous 12 months.
- Treatment with any dopaminergic blocking agent within the previous 3 months.
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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Idiopathic Parkinson's Disease
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Intervention(s)
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Drug: CD-LD IR Placebo
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Drug: CD-LD CR Placebo
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Drug: IPX054 200 mg Placebo
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Drug: IPX054 250 mg
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Drug: CD-LD CR
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Drug: IPX054 250 mg Placebo
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Drug: CD-LD IR
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Drug: IPX054 200 mg
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Primary Outcome(s)
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Alternate tapping of keys
[Time Frame: single dose]
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Secondary Outcome(s)
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Dyskinesia rating scale
[Time Frame: single dose]
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Timed walking
[Time Frame: single dose]
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Tremor score
[Time Frame: single dose]
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Secondary ID(s)
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IPX054-B05-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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