Parkinson's DiseasePhase 2NCT02271503
A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease
A Phase 2 study testing CD-LD IR, IPX203 180 mg and IPX203 270 mg in people with Parkinson's Disease, run by Impax Laboratories, LLC at 11 sites in United States.
Trial summary
This is a randomized, open-label, rater-blinded, multicenter, 3-treatment, 3 period, single-dose crossover study. Approximately 51 qualified immediate-release (IR) CD-LD-experienced advanced Parkinson's disease patients will be randomized to 1 of 3 dosing sequences. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- CD-LD IR, IPX203 180 mg and IPX203 270 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 11 sitesUnited States
- Study dates
- Nov 2015to Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects diagnosed with idiopathic PD with motor complications, who are currently being treated chronically with stable regimens of CD-LD.
- Requiring at least 400 mg but not more than 1600 mg LD per day during the waking hours; and at least 100 mg but not more than 250 mg LD from IR CD-LD for the first morning dose.
- Dosing frequency of IR CD-LD of at least 4 times daily excluding nighttime dosing.
- Have an average of at least 2 hours per day "off" time during the waking hours and at least 1 hour "off" time per day, based on the PD diary collected for 3 consecutive days prior to Visit 1.
Who cannot join
- Have used first morning dose of controlled-release (CR) CD-LD or Rytary for at least 4 weeks prior to Visit 1.
- Female subjects who are currently breastfeeding or lactating.
- Had prior functional neurosurgical treatment for PD (ablation or deep brain stimulation) or if such procedure(s) are planned or anticipated during the study period.
- Allergic to study drugs
- History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy or small-bowel resection.
- History of peptic ulcer disease or upper gastrointestinal hemorrhage.
Show all 12Show fewer
- History of narrow angle glaucoma.
- History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias; neuroleptic malignant syndrome; or nontraumatic rhabdomyolysis.
- History of psychosis.
- Employees or family members of the Investigator, study site, or Sponsor.
- Subjects who, in the opinion of the clinical investigator, should not participate in the study.
- Based on clinical assessment, subject does not adequately comprehend the terminology needed to complete the PD diary.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Georgia Regents University
Augusta, Georgia, 30912
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Duke University Movement Disorders Clinic
Durham, North Carolina, 27705
QUEST Research Institute
Farmington Hills, Michigan, 48334
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, 92708
Clinical Trials, Inc.
Little Rock, Arkansas, 72205
Collier Neurologic Specialists
Naples, Florida, 34102
Muhammad Ali Movement Disorder Center (MAMDC)
Phoenix, Arizona, 85013
Premier Clinical Research
Spokane, Washington, 99202
University of South Florida Parkinson's Disease and Movement Disorder Center
Tampa, Florida, 33613
About this study
Official title: A Study to Assess the Pharmacokinetics and Pharmacodynamics of a Single Dose of IPX203 in Patients With Advanced Parkinson's Disease
This is a randomized, open-label, rater-blinded, multicenter, 3-treatment, 3 period, single-dose crossover study. Approximately 51 qualified immediate-release (IR) CD-LD-experienced advanced Parkinson's disease patients will be randomized to 1 of 3 dosing sequences.
Objectives:
- Assess the pharmacodynamics and pharmacokinetics (PK) of IPX203 (carbidopa and levodopa) in subjects with advanced Parkinson's disease.
- Characterize the safety of IPX203 in subjects with advanced Parkinson's disease.
Read the detailed description
IPX203 contains two different drugs called levodopa and carbidopa in one capsule.
- levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease.
- carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.
- Conditions
- Parkinson's Disease
- Being tested
- CD-LD IR, IPX203 180 mg, IPX203 270 mg, Rytary 195 mg, Rytary 145 mg
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD-LD IRDrug
Also called Sinemet
CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
IPX203 180 mgDrug
Also called CD-LD ER 180 mg
IPX203 containing 45 mg carbidopa and180 mg levodopa
IPX203 270 mgDrug
Also called CD-LD ER 270 mg
IPX203 containing 67.5 mg carbidopa and 270 mg levodopa
Rytary 195 mgDrug
Rytary 48.75Mg-195Mg Extended-Release Capsule
Rytary 145 mgDrug
Rytary 36.25Mg-145Mg Extended-Release Capsule
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Other | Subject received a single dose of IPX203 180 mg and/or IPX203 270mg in Period 1, a single dose of CD-LD IR in Period 2, and a single dose of Rytary 145 mg and/or Rytary 195 mg in Period 3. Receives: Drug: CD-LD IR; Drug: IPX203 180 mg; Drug: IPX203 270 mg; Drug: Rytary 195 mg; Drug: Rytary 145 mg |
| Sequence 2 | Other | Subject received a single dose of a single dose of CD-LD IR in Period 1, a single dose of Rytary 145 mg and/or Rytary 195 mg in Period 2, and a single dose of IPX203 180 mg and/or IPX203 270mg in Period 3. Receives: Drug: CD-LD IR; Drug: IPX203 180 mg; Drug: IPX203 270 mg; Drug: Rytary 195 mg; Drug: Rytary 145 mg |
| Sequence 3 | Other | Subject received a single dose of a single dose of Rytary 145 mg and/or Rytary 195 mg in Period 1, a single dose of IPX203 180 mg and/or IPX203 270mg in Period 2, and a single dose of CD-LD IR in Period 3. Receives: Drug: CD-LD IR; Drug: IPX203 180 mg; Drug: IPX203 270 mg; Drug: Rytary 195 mg; Drug: Rytary 145 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Off" time per the Assessment of Subject's Motor State
Measured: Up to 10 hours
Secondary outcomes (2)
Duration of effect estimated using the timepoint at which an improvement of at least 4 points in the MDS-UPDRS Part III score from predose is first observed and continuing until the timepoint at which the improvement is no longer observed
Measured: Up to 10 hours
Change from predose value in the number of finger-taps at each timepoint
Measured: Up to 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startNov 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 26 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
- NCT02271503
- Sponsor's protocol ID
- IPX203-B14-02
- Status last verified
- Sep 2017
- First submitted
- 13 Oct 2014
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Pharmacokinetics and Pharmacodynamics of a Single Dose of IPX203 in Patients With Advanced Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02271503
- Acronym / sponsor ID
- IPX203-B14-02
- Conditions
- Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Impax Laboratories, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label, rater-blinded, multicenter, 3-treatment, 3 period, single-dose crossover study. Approximately 51 qualified immediate-release (IR) CD-LD-experienced advanced Parkinson's disease patients will be randomized to 1 of 3 dosing sequences.
Objectives:
- Assess the pharmacodynamics and pharmacokinetics (PK) of IPX203 (carbidopa and levodopa) in subjects with advanced Parkinson's disease.
- Characterize the safety of IPX203 in subjects with advanced Parkinson's disease.
Detailed description
IPX203 contains two different drugs called levodopa and carbidopa in one capsule.
- levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease.
- carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Other | Drug: CD-LD IR, Drug: IPX203 180 mg, Drug: IPX203 270 mg, Drug: Rytary 195 mg, Drug: Rytary 145 mgSubject received a single dose of IPX203 180 mg and/or IPX203 270mg in Period 1, a single dose of CD-LD IR in Period 2, and a single dose of Rytary 145 mg and/or Rytary 195 mg in Period 3. |
| Sequence 2 | Other | Drug: CD-LD IR, Drug: IPX203 180 mg, Drug: IPX203 270 mg, Drug: Rytary 195 mg, Drug: Rytary 145 mgSubject received a single dose of a single dose of CD-LD IR in Period 1, a single dose of Rytary 145 mg and/or Rytary 195 mg in Period 2, and a single dose of IPX203 180 mg and/or IPX203 270mg in Period 3. |
| Sequence 3 | Other | Drug: CD-LD IR, Drug: IPX203 180 mg, Drug: IPX203 270 mg, Drug: Rytary 195 mg, Drug: Rytary 145 mgSubject received a single dose of a single dose of Rytary 145 mg and/or Rytary 195 mg in Period 1, a single dose of IPX203 180 mg and/or IPX203 270mg in Period 2, and a single dose of CD-LD IR in Period 3. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects diagnosed with idiopathic PD with motor complications, who are currently being treated chronically with stable regimens of CD-LD.
- Requiring at least 400 mg but not more than 1600 mg LD per day during the waking hours; and at least 100 mg but not more than 250 mg LD from IR CD-LD for the first morning dose.
- Dosing frequency of IR CD-LD of at least 4 times daily excluding nighttime dosing.
- Have an average of at least 2 hours per day "off" time during the waking hours and at least 1 hour "off" time per day, based on the PD diary collected for 3 consecutive days prior to Visit 1.
Key exclusion criteria (12 listed)
- Have used first morning dose of controlled-release (CR) CD-LD or Rytary for at least 4 weeks prior to Visit 1.
- Female subjects who are currently breastfeeding or lactating.
- Had prior functional neurosurgical treatment for PD (ablation or deep brain stimulation) or if such procedure(s) are planned or anticipated during the study period.
- Allergic to study drugs
- History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy or small-bowel resection.
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 |
|---|---|---|
| CD-LD IRAlso: SinemetCD-LD IR containing 25 mg carbidopa and 100 mg levodopa | Drug | Sequence 1, Sequence 2, Sequence 3 |
| IPX203 180 mgAlso: CD-LD ER 180 mgIPX203 containing 45 mg carbidopa and180 mg levodopa | Drug | Sequence 1, Sequence 2, Sequence 3 |
| IPX203 270 mgAlso: CD-LD ER 270 mgIPX203 containing 67.5 mg carbidopa and 270 mg levodopa | Drug | Sequence 1, Sequence 2, Sequence 3 |
| Rytary 195 mgRytary 48.75Mg-195Mg Extended-Release Capsule | Drug | Sequence 1, Sequence 2, Sequence 3 |
| Rytary 145 mgRytary 36.25Mg-145Mg Extended-Release Capsule | Drug | Sequence 1, Sequence 2, Sequence 3 |
Primary outcome
"Off" time per the Assessment of Subject's Motor State
Time frame: Up to 10 hours
2 secondary outcomes
Duration of effect estimated using the timepoint at which an improvement of at least 4 points in the MDS-UPDRS Part III score from predose is first observed and continuing until the timepoint at which the improvement is no longer observed
Time frame: Up to 10 hours
Change from predose value in the number of finger-taps at each timepoint
Time frame: Up to 10 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Individual participant dataSharing planned: No
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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
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CD-LD IR, IPX203 180 mg and IPX203 270 mg in people with Parkinson's Disease, run by Impax Laboratories, LLC at 11 sites in United States.
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 4 inclusion and 12 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 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
"Off" time per the Assessment of Subject's Motor State (time frame: Up to 10 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2019.