Idiopathic Parkinson's DiseasePhase 1/2NCT00239564
Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease
A Phase 1/2 study testing IPX054 100 mg, IPX054 150 mg and IPX054 200 mg in people with Idiopathic Parkinson's Disease, run by Impax Laboratories, LLC at 2 sites in United States.
Trial summary
The objective is to compare the pharmacokinetics and pharmacodynamics of IPX054 and carbidopa-levodopa immediate-release tablets in subjects with idiopathic Parkinson's disease who are currently being treated with a stable regimen of carbidopa-levodopa immediate-release tablets. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Idiopathic Parkinson's Disease
- What is being tested?
- IPX054 100 mg, IPX054 150 mg and IPX054 200 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2005to Dec 2007
- Phase
- Phase 1/2
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of idiopathic Parkinson's disease
- Currently being treated with a stable dosage regimen of immediate-release carbidopa-levodopa for at least 3 months.
- Must experience at least 3 episodes of "wearing OFF" symptoms and an average of at least 2 hours of "OFF" time per day.
Who cannot join
- Diagnosed with atypical parkinsonism
- Prior surgical interventions for Parkinson's disease
- Glaucoma
- Undiagnosed skin lesion or history of melanoma
- Epilepsy or history of seizures
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Site 102
Lawrence, Kansas, 66045
Site 101
Sunnyvale, California, 94089
About this study
Official title: An Open-Label Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease
The objective is to compare the pharmacokinetics and pharmacodynamics of IPX054 and carbidopa-levodopa immediate-release tablets in subjects with idiopathic Parkinson's disease who are currently being treated with a stable regimen of carbidopa-levodopa immediate-release tablets.
Read the detailed description
IPX054 contains two different drugs called levodopa and carbidopa in one tablet.
- 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
- Idiopathic Parkinson's Disease
- Being tested
- IPX054 100 mg, IPX054 150 mg, IPX054 200 mg, IPX054 250 mg, IPX054 300 mg
- Keywords
- IPX054, Parkinson disease, Levodopa
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPX054 100 mgDrug
Also called CD-LD ER 100 mg
IPX054 containing 25 mg carbidopa and 100 mg levodopa
IPX054 150 mgDrug
Also called CD-LD ER 150 mg
IPX054 containing 37.5 mg carbidopa and 150 mg levodopa
IPX054 200 mgDrug
Also called CD-LD ER 200 mg
CD-LD CR containing 50 mg carbidopa and 200 mg levodopa
IPX054 250 mgDrug
Also called CD-LD ER 250 mg
CD-LD CR containing 62.5 mg carbidopa and 250 mg levodopa
IPX054 300 mgDrug
Also called CD-LD ER 300 mg
CD-LD CR containing 75 mg carbidopa and 300 mg levodopa
| Study group | Role | What they receive |
|---|---|---|
| Experimental: carbidopa and levodopa | Experimental | Subjects receive IPX054 100 mg, IPX054 150 mg, IPX054 200 mg, IPX054 250 mg, or IPX054 300 mg to achieve optimum dosage and dosing frequency as directed by the Investigator for 5 weeks. Receives: Drug: IPX054 100 mg; Drug: IPX054 150 mg; Drug: IPX054 200 mg; Drug: IPX054 250 mg; Drug: IPX054 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parkinsonian disability at Visits 1 and 5
Measured: 36 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT00239564
- Sponsor's protocol ID
- IPX054-B04-06
- Status last verified
- Jan 2017
- First submitted
- 13 Oct 2005
- Last updated
- 29 Oct 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 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00239564
- Acronym / sponsor ID
- IPX054-B04-06
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- IPX054, Parkinson disease, Levodopa
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Impax Laboratories, LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 17 Oct 2005 (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.
The objective is to compare the pharmacokinetics and pharmacodynamics of IPX054 and carbidopa-levodopa immediate-release tablets in subjects with idiopathic Parkinson's disease who are currently being treated with a stable regimen of carbidopa-levodopa immediate-release tablets.
Detailed description
IPX054 contains two different drugs called levodopa and carbidopa in one tablet.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: carbidopa and levodopa | Experimental | Drug: IPX054 100 mg, Drug: IPX054 150 mg, Drug: IPX054 200 mg, Drug: IPX054 250 mg, Drug: IPX054 300 mgSubjects receive IPX054 100 mg, IPX054 150 mg, IPX054 200 mg, IPX054 250 mg, or IPX054 300 mg to achieve optimum dosage and dosing frequency as directed by the Investigator for 5 weeks. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of idiopathic Parkinson's disease
- Currently being treated with a stable dosage regimen of immediate-release carbidopa-levodopa for at least 3 months.
- Must experience at least 3 episodes of "wearing OFF" symptoms and an average of at least 2 hours of "OFF" time per day.
Key exclusion criteria (5 listed)
- Diagnosed with atypical parkinsonism
- Prior surgical interventions for Parkinson's disease
- Glaucoma
- Undiagnosed skin lesion or history of melanoma
- Epilepsy or history of seizures
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 |
|---|---|---|
| IPX054 100 mgAlso: CD-LD ER 100 mgIPX054 containing 25 mg carbidopa and 100 mg levodopa | Drug | Experimental: carbidopa and levodopa |
| IPX054 150 mgAlso: CD-LD ER 150 mgIPX054 containing 37.5 mg carbidopa and 150 mg levodopa | Drug | Experimental: carbidopa and levodopa |
| IPX054 200 mgAlso: CD-LD ER 200 mgCD-LD CR containing 50 mg carbidopa and 200 mg levodopa | Drug | Experimental: carbidopa and levodopa |
| IPX054 250 mgAlso: CD-LD ER 250 mgCD-LD CR containing 62.5 mg carbidopa and 250 mg levodopa | Drug | Experimental: carbidopa and levodopa |
| IPX054 300 mgAlso: CD-LD ER 300 mgCD-LD CR containing 75 mg carbidopa and 300 mg levodopa | Drug | Experimental: carbidopa and levodopa |
Primary outcome
Parkinsonian disability at Visits 1 and 5
Time frame: 36 Days
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 29 Oct 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IPX054 100 mg, IPX054 150 mg and IPX054 200 mg in people with Idiopathic Parkinson's Disease, run by Impax Laboratories, LLC at 2 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 3 inclusion and 5 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 2 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Parkinsonian disability at Visits 1 and 5 (time frame: 36 Days). 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 29 Oct 2019.