Parkinson's DiseasePhase 2NCT00253084
Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease
A Phase 2 study testing IPX054 200 mg and CD-LD IR in people with Parkinson's Disease, run by Impax Laboratories, LLC at 2 sites in United States.
Trial summary
The purpose of this study is to compare the clinical efficacy of IPX054 to immediate-release carbidopa-levodopa in subjects with 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?
- IPX054 200 mg and CD-LD IR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2005to Dec 2007
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with idiopathic Parkinson's disease based on CAPIT (Core Assessment Program for Intracerebral Transplantations) criteria.
- Currently being treated with immediate-release carbidopa-levodopa with a stable dosing regimen over the past 4 weeks.
Who cannot join
- Diagnosed with atypical parkinsonism.
- Allergic or non-responsive to previous carbidopa-levodopa therapy.
- Active or history of narrow-angle or wide-angle glaucoma.
- History of seizure or epilepsy, or is currently taking an anti-convulsant for treatment of seizure.
- Requires concomitant therapy with tricyclic antidepressants, MAO-B inhibitors, COMT inhibitors or anticholinergics.
- Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 6 months.
- Treatment with any dopaminergic blocking agent within the previous 6 months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Site 2
Charleston, South Carolina, 29425
Site 1
Chicago, Illinois, 60612
About this study
Official title: A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease
The purpose of this study is to compare the clinical efficacy of IPX054 to immediate-release carbidopa-levodopa in subjects with Parkinson's disease.
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
- Parkinson's Disease
- Being tested
- IPX054 200 mg, CD-LD IR, IPX054 Placebo, CD-LD IR Placebo
- 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 200 mgDrug
Also called CD-LD ER 200 mg
IPX054 containing 50 mg carbidopa and 200 mg levodopa
CD-LD IRDrug
CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
IPX054 PlaceboDrug
Placebo to match IPX054 200 mg
CD-LD IR PlaceboDrug
Placebo to match CD-LD IR
| Study group | Role | What they receive |
|---|---|---|
| IPX054 - CD-LD IR | Other | Subjects received IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks and then received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks. Receives: Drug: IPX054 200 mg; Drug: CD-LD IR; Drug: IPX054 Placebo; Drug: CD-LD IR Placebo |
| CD-LD IR - IPX054 | Other | Subjects received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks and then IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks. Receives: Drug: IPX054 200 mg; Drug: CD-LD IR; Drug: IPX054 Placebo; Drug: CD-LD IR Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
"ON" time without disabling dyskinesias
Measured: 2 weeks
Secondary outcomes (3)
UPDRS analysis
Measured: 2 weeks
Mean time to "ON"
Measured: 2 weeks
Mean time to "wearing OFF"
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startNov 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 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- 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
- NCT00253084
- Sponsor's protocol ID
- IPX054-B04-07
- Status last verified
- Jan 2017
- First submitted
- 11 Nov 2005
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- 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
- A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00253084
- Acronym / sponsor ID
- IPX054-B04-07
- Conditions
- Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Impax Laboratories, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Nov 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 purpose of this study is to compare the clinical efficacy of IPX054 to immediate-release carbidopa-levodopa in subjects with Parkinson's disease.
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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPX054 - CD-LD IR | Other | Drug: IPX054 200 mg, Drug: CD-LD IR, Drug: IPX054 Placebo, Drug: CD-LD IR PlaceboSubjects received IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks and then received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks. |
| CD-LD IR - IPX054 | Other | Drug: IPX054 200 mg, Drug: CD-LD IR, Drug: IPX054 Placebo, Drug: CD-LD IR PlaceboSubjects received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks and then IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with idiopathic Parkinson's disease based on CAPIT (Core Assessment Program for Intracerebral Transplantations) criteria.
- Currently being treated with immediate-release carbidopa-levodopa with a stable dosing regimen over the past 4 weeks.
Key exclusion criteria (7 listed)
- Diagnosed with atypical parkinsonism.
- Allergic or non-responsive to previous carbidopa-levodopa therapy.
- Active or history of narrow-angle or wide-angle glaucoma.
- History of seizure or epilepsy, or is currently taking an anti-convulsant for treatment of seizure.
- Requires concomitant therapy with tricyclic antidepressants, MAO-B inhibitors, COMT inhibitors or anticholinergics.
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 200 mgAlso: CD-LD ER 200 mgIPX054 containing 50 mg carbidopa and 200 mg levodopa | Drug | CD-LD IR - IPX054, IPX054 - CD-LD IR |
| CD-LD IRCD-LD IR containing 25 mg carbidopa and 100 mg levodopa | Drug | CD-LD IR - IPX054, IPX054 - CD-LD IR |
| IPX054 PlaceboPlacebo to match IPX054 200 mg | Drug | CD-LD IR - IPX054, IPX054 - CD-LD IR |
| CD-LD IR PlaceboPlacebo to match CD-LD IR | Drug | CD-LD IR - IPX054, IPX054 - CD-LD IR |
Primary outcome
"ON" time without disabling dyskinesias
Time frame: 2 weeks
3 secondary outcomes
UPDRS analysis
Time frame: 2 weeks
Mean time to "ON"
Time frame: 2 weeks
Mean time to "wearing OFF"
Time frame: 2 weeks
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 2 study testing IPX054 200 mg and CD-LD IR in people with 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 2 inclusion and 7 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 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?
"ON" time without disabling dyskinesias (time frame: 2 weeks). 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.