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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: |
NCT00880620 |
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Date of registration:
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03/04/2009 |
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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 Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease
APEX-PD |
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Scientific title:
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A Placebo-Controlled Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease |
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Date of first enrolment:
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April 2009 |
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Target sample size:
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381 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00880620 |
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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: Parallel 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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Canada
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Estonia
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Latvia
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Lithuania
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Romania
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Ukraine
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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. Able to understand and willing to voluntarily sign an informed consent form (ICF) and
Health Insurance Portability and Accountability Act (HIPAA) authorization or local
equivalent if applicable.
2. Diagnosed with idiopathic PD.
3. LD-naïve: defined as subjects not exposed to LD or catechol-O-methyl transferase
inhibitors for more than 30 days and the exposure is not within 4 weeks prior to study
enrollment.
4. If currently taking anticholinergic therapy, amantadine, or a monoamine oxidase type B
(MAO-B) inhibitor, maintains a stable regimen for at least 4 weeks prior to Baseline,
and agrees to maintain the stable regimen throughout study participation.
5. Agrees to use a medically acceptable method of contraception throughout the study and
for 1 month after completing the study.
6. Able and willing to comply with the protocol, including availability for all scheduled
clinic visits and telephone calls.
Exclusion Criteria:
1. Pregnant or breastfeeding.
2. Diagnosed with atypical Parkinsonism or any known secondary parkinsonian syndrome.
3. Prior functional neurosurgical treatment for PD or if such procedures are anticipated
during study participation.
4. Use of nonselective MAO inhibitors.
5. Use of dopamine agonists within 30 days prior to Screening.
6. Unable to tolerate a placebo regimen, in the Investigator's opinion.
7. Treatment of psychosis with any antipsychotic.
8. History of seizure or epilepsy.
9. Active or prior medical condition or prior surgical procedure that would interfere
with LD absorption.
10. History of narrow-angle glaucoma.
11. Subjects with a history of malignant melanoma.
12. History of myocardial infarction with residual atrial, nodal, or ventricular
arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome.
13. Received any investigational medications during the 30 days prior to Screening.
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: IPX066 145 mg LD
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Drug: IPX066 245 mg LD
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Drug: Placebo
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Drug: IPX066 195 mg LD
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Drug: IPX066 95 mg LD
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Primary Outcome(s)
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Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III at Week 30
[Time Frame: Week 30]
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Secondary Outcome(s)
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Summary of Change From Baseline to End of Study in Mean Parkinson's Disease Questionnaire-39 (PDQ-39) Score
[Time Frame: Baseline and Week 30 (or End of Study)]
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Secondary ID(s)
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IPX066-B08-05
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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