A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease
NCT ID: NCT00880620
Last Updated: 2019-10-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
381 participants
INTERVENTIONAL
2009-04-30
2010-11-30
Brief Summary
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Detailed Description
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Total of 427 subjects were screened and 381 were randomized and received one of the four treatment groups (1) placebo (N=92), (2) IPX066 145 mg LD (N=87) (3) IPX066 245 mg LD (N=104) (4) IPX066 390 mg LD (N=98) three times a day.
Study duration is approximately 30 weeks for each subject including 4 weeks of titration (up to 3 weeks of dose escalation and I week of stabilization for safe escalation to the allocated dose), and 26 weeks of maintenance.
During the titration phase:
The following dose strengths were used to titrate up to the final three strengths that were assigned to the three IPX066 treatment arms.
IPX066 95 mg LD capsule containing 95 mg LD and 23.75 mg CD. IPX066 145 mg LD capsule containing 145 mg LD and 36.25 mg CD. IPX066 195 mg LD capsule containing 195 mg LD and 48.75 mg CD. IPX066 245 mg LD capsule containing 245 mg LD and 61.25 mg CD.
During the maintenance phase:
IPX066 145 mg LD treatment arm received 145 mg LD and 36.25 mg CD. IPX066 245 mg LD treatment arm received 245 mg LD and 61.25 mg CD. IPX066 390 mg LD treatment arm received 390 mg LD and 97.50 mg CD.
Primary efficacy outcome measure was change from baseline in the sum of UPDRS Part II and Part III scores at the end of study or last value reported if subject discontinued prematurely.
Summary of Change From Baseline to End of Study in Mean Parkinson's Disease Questionnaire-39 (PDQ-39) Score.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
One Placebo capsule was given TID for the first 21 days. Two placebo capsules were given TID on days 22 till end of study (week 30).
Placebo
Placebo
IPX066 145 mg LD
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-21. One IPX066 145 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).
Placebo
Placebo
IPX066 95 mg LD
IPX066 capsule containing 95 mg LD/23.75 mg CD
IPX066 145 mg LD
IPX066 capsule containing 145 mg LD/36.25 mg CD
IPX066 245 mg LD
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. One IPX066 245 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).
Placebo
Placebo
IPX066 95 mg LD
IPX066 capsule containing 95 mg LD/23.75 mg CD
IPX066 145 mg LD
IPX066 capsule containing 145 mg LD/36.25 mg CD
IPX066 195 mg LD
IPX066 capsule containing 195 mg LD/48.75 mg CD
IPX066 245 mg LD
IPX066 capsule containing 245 mg LD/61.25 mg CD
IPX066 390 mg LD
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. Two IPX066 195 mg LD capsules were given TID on days 22 till end of study (week 30).
IPX066 95 mg LD
IPX066 capsule containing 95 mg LD/23.75 mg CD
IPX066 145 mg LD
IPX066 capsule containing 145 mg LD/36.25 mg CD
IPX066 195 mg LD
IPX066 capsule containing 195 mg LD/48.75 mg CD
IPX066 245 mg LD
IPX066 capsule containing 245 mg LD/61.25 mg CD
Interventions
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Placebo
Placebo
IPX066 95 mg LD
IPX066 capsule containing 95 mg LD/23.75 mg CD
IPX066 145 mg LD
IPX066 capsule containing 145 mg LD/36.25 mg CD
IPX066 195 mg LD
IPX066 capsule containing 195 mg LD/48.75 mg CD
IPX066 245 mg LD
IPX066 capsule containing 245 mg LD/61.25 mg CD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
30 Years
ALL
No
Sponsors
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Impax Laboratories, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Impax Study Director
Role: STUDY_DIRECTOR
Impax Laboratories, LLC
Locations
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University of Alabama at Birmingham, Dept. of Neurology
Birmingham, Alabama, United States
HOPE Research Institute, LLC
Phoenix, Arizona, United States
Collaborative NeuroScience Network, Inc.
Garden Grove, California, United States
Coastal Neurological Medical Group
La Jolla, California, United States
Coordinated Clinical Research
La Jolla, California, United States
The Parkinson's Institute
Sunnyvale, California, United States
Yale Neurology Clinics, Temple Medical Center
New Haven, Connecticut, United States
Bradenton Research Center, Inc.
Bradenton, Florida, United States
Sunrise Clinical Research, Inc.
Hollywood, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Charlotte Neurological Services
Port Charlotte, Florida, United States
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, United States
University of South Florida
Tampa, Florida, United States
Idaho Elks Rehabilitation Hospital
Boise, Idaho, United States
Rush University Medical Center, Dept. of Neurological Sciences
Chicago, Illinois, United States
Landon Center on Aging, Dept. of Neurology, Parkinson's Disease Center
Kansas City, Kansas, United States
Boston University School of Medicine
Boston, Massachusetts, United States
Quest Research Institute
Bingham Farms, Michigan, United States
Struthers Parkinson's Center
Golden Valley, Minnesota, United States
UMDNJ Robert Wood Johnson Medical Center, Department of Neurology
New Brunswick, New Jersey, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University
New York, New York, United States
State University of New York Upstate Medical University, Dept. of Neurology
Syracuse, New York, United States
Duke University Medical Center Movement Disorders Center
Durham, North Carolina, United States
University of Toledo
Toledo, Ohio, United States
Baylor College of Medicine, Parkinson's Disease Center
Houston, Texas, United States
Wisconsin Institute for Neurologic and Sleep Disorders
Milwaukee, Wisconsin, United States
Movement Disorders Clinic, Glenrose Rehabilitation Hospital
Edmonton, Alberta, Canada
Saint Boniface Clinic
Winnipeg, Manitoba, Canada
London Health Science Center
London, Ontario, Canada
Parkinson's and Neurodegenerative Disorders Clinic
Ottawa, Ontario, Canada
Ottawa Hospital Civic Site
Ottawa, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Memory and Motor Skills Clinic
Québec, Quebec, Canada
University of Sherbrooke
Sherbrooke, Quebec, Canada
East Tallinn Central Hospital
Tallinn, , Estonia
West Tallin Central Hopsital
Tallinn, , Estonia
P.Stradina university hospital
Riga, , Latvia
Gailezers hospital
Riga, , Latvia
Kaunas Medical University Hospital
Kaunas, , Lithuania
Siauliai Regional Hospital
Šiauliai, , Lithuania
Vilnius University Emergency Hospital
Vilnius, , Lithuania
Vilnius University Centre of Gerontology and Rehabilitation
Vilnius, , Lithuania
Vilnius University Hospital Santariskiu klinikos
Vilnius, , Lithuania
Psychiatry and Neurology Hospital, Neurology Department
Brasov, , Romania
Colentina Clinical Hospital Bucharest, II Neurology Department
Bucharest, , Romania
County Emergency Clinical Hospital Cluj-Napoca, I Neurology Clinic
Cluj-Napoca, , Romania
CFR Clinical Hospital Constanta
Constanța, , Romania
Clinical Rehabilitation Hospital Iasi, Neurology Department
Iași, , Romania
County Clinical Emergency Hospital, Targu Mures, II Neurology Department,
Târgu Mureş, , Romania
County Clinical Emergency Hospital Timisoara
Timișoara, , Romania
Neurology department of Regional hospital named after Mechnikov
Dnipro, , Ukraine
Department of Psychiatry and Medical Psychology of Donetsk National Medical University
Donetsk, , Ukraine
Department of Neurological Diseases and Medical Genetic of Donetsk National Medical University
Donetsk, , Ukraine
1st neurology department of Central Clinical Hospital of Ukrzaliznytsya
Kharkiv, , Ukraine
Institute of Gerontology Parkinson's Disease Center
Kiev, , Ukraine
Neurology department of Lviv regional clinical hospital
Lviv, , Ukraine
Neurology department of Medical Dental Academy based on Poltava regional hospital
Poltava, , Ukraine
Neurology department of Vinnitsa Medical University
Vinnitsa, , Ukraine
Neurology department, Zaporozhye State Medical University
Zaporizhzhya, , Ukraine
Countries
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References
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Pahwa R, Lyons KE, Hauser RA, Fahn S, Jankovic J, Pourcher E, Hsu A, O'Connell M, Kell S, Gupta S; APEX-PD Investigators. Randomized trial of IPX066, carbidopa/levodopa extended release, in early Parkinson's disease. Parkinsonism Relat Disord. 2014 Feb;20(2):142-8. doi: 10.1016/j.parkreldis.2013.08.017. Epub 2013 Sep 5.
Other Identifiers
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IPX066-B08-05
Identifier Type: -
Identifier Source: org_study_id
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