Idiopathic Parkinson's DiseasePhase 2NCT00279825

Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease

A Phase 2 study testing IPX054 200 mg, IPX054 250 mg and CD-LD IR in people with Idiopathic Parkinson's Disease, run by Impax Laboratories, LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to compare the pharmacokinetics and pharmacodynamics of IPX054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa controlled-release tablets in subjects with idiopathic Parkinson's disease. 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 200 mg, IPX054 250 mg and CD-LD IR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 2 sitesUnited States
Study dates: Jan 2006to 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.
Currently being treated with immediate-release or controlled-release carbidopa-levodopa and not requiring more than 200 mg levodopa per dose.
Must experience "wearing OFF" between doses of medication.

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 seizures.
Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 12 months.
Treatment with any dopaminergic blocking agent within the previous 3 months.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Quest Research Institute
Bingham Farms, Michigan, 48025
Oregon Health Sciences University - Parkinson's Center of Oregon
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Compare IPX054 200 mg and 250 mg to CD-LD IR 200 (2x100) mg Tablets and CD-LD CR 200 mg Tablet 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: Idiopathic Parkinson's Disease
Being tested: IPX054 200 mg, IPX054 250 mg, CD-LD IR, CD-LD CR, IPX054 200 mg 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
IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa
IPX054 250 mgDrug
IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa
CD-LD IRDrug
Also called Carbidopa-levodopa immediate-release tablets
Active comparator containing 25 mg carbidopa and 100 mg levodopa
CD-LD CRDrug
Also called Carbidopa-levodopa controlled-release tablets
Active comparator containing 50 mg carbidopa and 200 mg levodopa
IPX054 200 mg PlaceboDrug
Placebo to match IPX054 200 mg
IPX054 250 mg PlaceboDrug
Placebo to match IPX054 250 mg
CD-LD IR PlaceboDrug
Placebo to match CD-LD IR
CD-LD CR PlaceboDrug
Placebo to match CD-LD CR

Study groups in NCT00279825
Study group	Role	What they receive
Sequence 1	Other	Subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. Receives: Drug: IPX054 200 mg; Drug: IPX054 250 mg; Drug: CD-LD IR; Drug: CD-LD CR; Drug: IPX054 200 mg Placebo; Drug: IPX054 250 mg Placebo; Drug: CD-LD IR Placebo; Drug: CD-LD CR Placebo
Sequence 2	Other	Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. Receives: Drug: IPX054 200 mg; Drug: IPX054 250 mg; Drug: CD-LD IR; Drug: CD-LD CR; Drug: IPX054 200 mg Placebo; Drug: IPX054 250 mg Placebo; Drug: CD-LD IR Placebo; Drug: CD-LD CR Placebo
Sequence 3	Other	Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Third treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. Receives: Drug: IPX054 200 mg; Drug: IPX054 250 mg; Drug: CD-LD IR; Drug: CD-LD CR; Drug: IPX054 200 mg Placebo; Drug: IPX054 250 mg Placebo; Drug: CD-LD IR Placebo; Drug: CD-LD CR Placebo
Sequence 4	Other	Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. Receives: Drug: IPX054 200 mg; Drug: IPX054 250 mg; Drug: CD-LD IR; Drug: CD-LD CR; Drug: IPX054 200 mg Placebo; Drug: IPX054 250 mg Placebo; Drug: CD-LD IR Placebo; Drug: CD-LD CR Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Alternate tapping of keys
Measured: single dose

Secondary outcomes (3)

Timed walking
Measured: single dose
Tremor score
Measured: single dose
Dyskinesia rating scale
Measured: single dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2006Dec 2007

First posted20 Jan 2006 (estimated)
Study startJan 2006
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00279825
Sponsor's protocol ID: IPX054-B05-01
Status last verified: Jan 2017
First submitted: 18 Jan 2006
Last updated: 29 Oct 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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MediPD: An Online Mediterranean Diet Program for People Living With Parkinson's Disease
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All Idiopathic Parkinson's Disease trials

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, Placebo-Controlled, Crossover Study to Compare IPX054 200 mg and 250 mg to CD-LD IR 200 (2x100) mg Tablets and CD-LD CR 200 mg Tablet in Subjects With Parkinson's Disease
ClinicalTrials.gov ID: NCT00279825
Acronym / sponsor ID: IPX054-B05-01
Conditions: Idiopathic Parkinson's Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Impax Laboratories, LLCIndustry (pharma, biotech, devices)
Study start: Jan 2006
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 20 Jan 2006 (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.

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: 4

Arm	Type	Receives
Sequence 1	Other	Drug: IPX054 200 mg, Drug: IPX054 250 mg, Drug: CD-LD IR, Drug: CD-LD CR, Drug: IPX054 200 mg Placebo, Drug: IPX054 250 mg Placebo, Drug: CD-LD IR Placebo, Drug: CD-LD CR PlaceboSubjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR.
Sequence 2	Other	Drug: IPX054 200 mg, Drug: IPX054 250 mg, Drug: CD-LD IR, Drug: CD-LD CR, Drug: IPX054 200 mg Placebo, Drug: IPX054 250 mg Placebo, Drug: CD-LD IR Placebo, Drug: CD-LD CR PlaceboSubjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo.
Sequence 3	Other	Drug: IPX054 200 mg, Drug: IPX054 250 mg, Drug: CD-LD IR, Drug: CD-LD CR, Drug: IPX054 200 mg Placebo, Drug: IPX054 250 mg Placebo, Drug: CD-LD IR Placebo, Drug: CD-LD CR PlaceboSubjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Third treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo.
Sequence 4	Other	Drug: IPX054 200 mg, Drug: IPX054 250 mg, Drug: CD-LD IR, Drug: CD-LD CR, Drug: IPX054 200 mg Placebo, Drug: IPX054 250 mg Placebo, Drug: CD-LD IR Placebo, Drug: CD-LD CR PlaceboSubjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo.

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosed with idiopathic Parkinson's disease.
Currently being treated with immediate-release or controlled-release carbidopa-levodopa and not requiring more than 200 mg levodopa per dose.
Must experience "wearing OFF" between doses of medication.

Key exclusion criteria (6 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 seizures.
Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 12 months.

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 mgIPX054 tablet containing 50 mg carbidopa and 200 mg levodopa	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4
IPX054 250 mgIPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4
CD-LD IRAlso: Carbidopa-levodopa immediate-release tabletsActive comparator containing 25 mg carbidopa and 100 mg levodopa	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4
CD-LD CRAlso: Carbidopa-levodopa controlled-release tabletsActive comparator containing 50 mg carbidopa and 200 mg levodopa	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4
IPX054 200 mg PlaceboPlacebo to match IPX054 200 mg	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4
IPX054 250 mg PlaceboPlacebo to match IPX054 250 mg	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4
CD-LD IR PlaceboPlacebo to match CD-LD IR	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4
CD-LD CR PlaceboPlacebo to match CD-LD CR	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4

Primary outcome

Alternate tapping of keys
Time frame: single dose

3 secondary outcomes

Timed walking
Time frame: single dose
Tremor score
Time frame: single dose
Dyskinesia rating scale
Time frame: single dose

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

Related trials for Idiopathic Parkinson's Disease

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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, IPX054 250 mg and CD-LD IR 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 6 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?

Alternate tapping of keys (time frame: single dose). 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 NCT00279825.

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.