Parkinson's DiseasePhase 3APEX-PDNCT00880620
A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease
A Phase 3 study testing IPX066 95 mg LD, IPX066 145 mg LD and IPX066 195 mg LD in people with Parkinson's Disease, run by Impax Laboratories, LLC at 60 sites in 7 countries.
Trial summary
This study examines the efficacy of three doses of IPX066 as compared to placebo in Parkinson's disease. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- IPX066 95 mg LD, IPX066 145 mg LD and IPX066 195 mg LD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 381 participants
- Where
- 60 sitesin 7 countries
- Study dates
- Apr 2009to Nov 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Diagnosed with idiopathic PD.
- 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.
- 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.
- Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study.
- Able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.
Who cannot join
- Pregnant or breastfeeding.
- Diagnosed with atypical Parkinsonism or any known secondary parkinsonian syndrome.
- Prior functional neurosurgical treatment for PD or if such procedures are anticipated during study participation.
- Use of nonselective MAO inhibitors.
- Use of dopamine agonists within 30 days prior to Screening.
- Unable to tolerate a placebo regimen, in the Investigator's opinion.
Show all 13Show fewer
- Treatment of psychosis with any antipsychotic.
- History of seizure or epilepsy.
- Active or prior medical condition or prior surgical procedure that would interfere with LD absorption.
- History of narrow-angle glaucoma.
- Subjects with a history of malignant melanoma.
- History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome.
- Received any investigational medications during the 30 days prior to Screening.
Trial locations and contacts
60 sites in 7 countries.
60 sites in 7 countries
United States27 sites
Quest Research Institute
Bingham Farms, Michigan, 48025
University of Alabama at Birmingham, Dept. of Neurology
Birmingham, Alabama, 35233
Idaho Elks Rehabilitation Hospital
Boise, Idaho, 83702
Boston University School of Medicine
Boston, Massachusetts, 02118
Bradenton Research Center, Inc.
Bradenton, Florida, 34205
Rush University Medical Center, Dept. of Neurological Sciences
Chicago, Illinois, 60612
Duke University Medical Center Movement Disorders Center
Durham, North Carolina, 27705
Collaborative NeuroScience Network, Inc.
Garden Grove, California, 92845
Struthers Parkinson's Center
Golden Valley, Minnesota, 55427
Sunrise Clinical Research, Inc.
Hollywood, Florida, 23021
Baylor College of Medicine, Parkinson's Disease Center
Houston, Texas, 77030
Landon Center on Aging, Dept. of Neurology, Parkinson's Disease Center
Kansas City, Kansas, 66160-7314
Coastal Neurological Medical Group
La Jolla, California, 92037
Coordinated Clinical Research
La Jolla, California, 92037
Wisconsin Institute for Neurologic and Sleep Disorders
Milwaukee, Wisconsin, 53233
UMDNJ Robert Wood Johnson Medical Center, Department of Neurology
New Brunswick, New Jersey, 08901
Yale Neurology Clinics, Temple Medical Center
New Haven, Connecticut, 06510
Mount Sinai School of Medicine
New York, New York, 10029
Columbia University
New York, New York, 10032
Renstar Medical Research
Ocala, Florida, 34471
HOPE Research Institute, LLC
Phoenix, Arizona, 85050
Charlotte Neurological Services
Port Charlotte, Florida, 33952
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33713
The Parkinson's Institute
Sunnyvale, California, 94085
State University of New York Upstate Medical University, Dept. of Neurology
Syracuse, New York, 13210
University of South Florida
Tampa, Florida, 33612
University of Toledo
Toledo, Ohio, 43614
Ukraine9 sites
Neurology department of Regional hospital named after Mechnikov
Dnipro, 49005
Department of Psychiatry and Medical Psychology of Donetsk National Medical University
Donetsk, 83037
Department of Neurological Diseases and Medical Genetic of Donetsk National Medical University
Donetsk, 83099
1st neurology department of Central Clinical Hospital of Ukrzaliznytsya
Kharkiv, Kharkiv
Institute of Gerontology Parkinson's Disease Center
Kiev, 04114
Neurology department of Lviv regional clinical hospital
Lviv, 79010
Neurology department of Medical Dental Academy based on Poltava regional hospital
Poltava, 36000
Neurology department of Vinnitsa Medical University
Vinnitsa, 21018
Neurology department, Zaporozhye State Medical University
Zaporizhzhya, 69035
Canada8 sites
Movement Disorders Clinic, Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5G 0B7
London Health Science Center
London, Ontario, N6A 5A5
Parkinson's and Neurodegenerative Disorders Clinic
Ottawa, Ontario, K1G 4G3
Ottawa Hospital Civic Site
Ottawa, Ontario, K1Y 4E9
Memory and Motor Skills Clinic
Québec, Quebec, G1R 3X5
University of Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Saint Boniface Clinic
Winnipeg, Manitoba, R3J2H7
Romania7 sites
Psychiatry and Neurology Hospital, Neurology Department
Brasov, 500123
Colentina Clinical Hospital Bucharest, II Neurology Department
Bucharest, 020125
County Emergency Clinical Hospital Cluj-Napoca, I Neurology Clinic
Cluj-Napoca, 400012
CFR Clinical Hospital Constanta
Constanța, 900123
Clinical Rehabilitation Hospital Iasi, Neurology Department
Iași
County Clinical Emergency Hospital, Targu Mures, II Neurology Department,
Târgu Mureş, 540136
County Clinical Emergency Hospital Timisoara
Timișoara, 300736
Lithuania5 sites
Kaunas Medical University Hospital
Kaunas, LT-50009
Siauliai Regional Hospital
Šiauliai, LT- 76231
Vilnius University Emergency Hospital
Vilnius, LT-04130
Vilnius University Centre of Gerontology and Rehabilitation
Vilnius, LT-08420
Vilnius University Hospital Santariskiu klinikos
Vilnius, LT-08661
Estonia2 sites
East Tallinn Central Hospital
Tallinn, 10138
West Tallin Central Hopsital
Tallinn, 10617
About this study
Official title: A Placebo-Controlled Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease
This study examines the efficacy of three doses of IPX066 as compared to placebo in Parkinson's disease.
Read the detailed description
A randomized, double-blind, placebo-controlled, fixed-dose, parallel-arm study of three doses of IPX066 versus placebo.
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
- Parkinson's Disease
- Being tested
- Placebo, IPX066 95 mg LD, IPX066 145 mg LD, IPX066 195 mg LD, IPX066 245 mg LD
- Keywords
- Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
IPX066 95 mg LDDrug
Also called CD-LD ER 95 mg
IPX066 capsule containing 95 mg LD/23.75 mg CD
IPX066 145 mg LDDrug
Also called CD-LD ER 145 mg
IPX066 capsule containing 145 mg LD/36.25 mg CD
IPX066 195 mg LDDrug
Also called CD-LD ER 195 mg
IPX066 capsule containing 195 mg LD/48.75 mg CD
IPX066 245 mg LDDrug
Also called CD-LD ER 245 mg
IPX066 capsule containing 245 mg LD/61.25 mg CD
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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). Receives: Drug: Placebo |
| IPX066 145 mg LD | Experimental | 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). Receives: Drug: Placebo; Drug: IPX066 95 mg LD; Drug: IPX066 145 mg LD |
| IPX066 245 mg LD | Experimental | 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). Receives: Drug: Placebo; Drug: IPX066 95 mg LD; Drug: IPX066 145 mg LD; Drug: IPX066 195 mg LD; Drug: IPX066 245 mg LD |
| IPX066 390 mg LD | Experimental | 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). Receives: Drug: IPX066 95 mg LD; Drug: IPX066 145 mg LD; Drug: IPX066 195 mg LD; Drug: IPX066 245 mg LD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III at Week 30
Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at Week 30 (End of Study).
Unified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome.
Subscales II and III were summed:
Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25
Measured: Week 30
Secondary outcomes (1)
Summary of Change From Baseline to End of Study in Mean Parkinson's Disease Questionnaire-39 (PDQ-39) Score
Change from Baseline in Parkinson's disease Questionnaire 39 (PDQ-39) at Weeks 4, 9, 16, 23 and 30 or early discontinuation was collected. The PDQ-39 is a self-reported questionnaire consisting of 39 questions regarding the subjects mobility and the responses consist of "Never" (better in outcome), (value 0), "Occasionally" (value 1), "Sometimes" (value 2), , "Often" (value 3), and "Always" (value 4), (worse in outcome). The minimum possible score is "0" and the maximum is "156". The outcome measure calculated was the change from baseline to end of study in mean PDQ-39 score. Negative values indicate a better result.
Measured: Baseline and Week 30 (or End of Study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionOct 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Impax Laboratories, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Impax Study Director, Study director, Impax Laboratories, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880620
- Sponsor's protocol ID
- IPX066-B08-05
- Acronym
- APEX-PD
- Status last verified
- Aug 2017
- First submitted
- 3 Apr 2009
- Last updated
- 29 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24055014
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00880620
- Acronym / sponsor ID
- APEX-PD / IPX066-B08-05
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Impax Laboratories, LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 14 Apr 2009 (estimated)
- Results
- Posted 22 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the efficacy of three doses of IPX066 as compared to placebo in Parkinson's disease.
Detailed description
A randomized, double-blind, placebo-controlled, fixed-dose, parallel-arm study of three doses of IPX066 versus placebo.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboOne 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). |
| IPX066 145 mg LD | Experimental | Drug: Placebo, Drug: IPX066 95 mg LD, Drug: IPX066 145 mg LDOne 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). |
| IPX066 245 mg LD | Experimental | Drug: Placebo, Drug: IPX066 95 mg LD, Drug: IPX066 145 mg LD, Drug: IPX066 195 mg LD, Drug: IPX066 245 mg LDOne 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). |
| IPX066 390 mg LD | Experimental | Drug: IPX066 95 mg LD, Drug: IPX066 145 mg LD, Drug: IPX066 195 mg LD, Drug: IPX066 245 mg LDOne 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). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Diagnosed with idiopathic PD.
- 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.
- 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.
- Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study.
Key exclusion criteria (13 listed)
- Pregnant or breastfeeding.
- Diagnosed with atypical Parkinsonism or any known secondary parkinsonian syndrome.
- Prior functional neurosurgical treatment for PD or if such procedures are anticipated during study participation.
- Use of nonselective MAO inhibitors.
- Use of dopamine agonists within 30 days prior to Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo | Drug | IPX066 145 mg LD, IPX066 245 mg LD, Placebo |
| IPX066 95 mg LDAlso: CD-LD ER 95 mgIPX066 capsule containing 95 mg LD/23.75 mg CD | Drug | IPX066 145 mg LD, IPX066 245 mg LD, IPX066 390 mg LD |
| IPX066 145 mg LDAlso: CD-LD ER 145 mgIPX066 capsule containing 145 mg LD/36.25 mg CD | Drug | IPX066 145 mg LD, IPX066 245 mg LD, IPX066 390 mg LD |
| IPX066 195 mg LDAlso: CD-LD ER 195 mgIPX066 capsule containing 195 mg LD/48.75 mg CD | Drug | IPX066 245 mg LD, IPX066 390 mg LD |
| IPX066 245 mg LDAlso: CD-LD ER 245 mgIPX066 capsule containing 245 mg LD/61.25 mg CD | Drug | IPX066 245 mg LD, IPX066 390 mg LD |
Primary outcome
Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III at Week 30
Time frame: Week 30
Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at Week 30 (End of Study). Unified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome. Subscales II and III were summed: Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25
1 secondary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24055014Pahwa 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.
- Individual participant dataSharing planned: No
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Impax Study Director study director
Impax Laboratories, LLC
60 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IPX066 95 mg LD, IPX066 145 mg LD and IPX066 195 mg LD in people with Parkinson's Disease, run by Impax Laboratories, LLC at 60 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Ukraine, Canada, Romania, Lithuania and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III at Week 30 (time frame: Week 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00880620, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.