Advanced Parkinson's DiseasePhase 2NCT03007888

A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease

A Phase 2 study testing Sinemet and IPX203 in people with Advanced Parkinson's Disease, run by Impax Laboratories, LLC at 11 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

Primary Objective: To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD). Secondary Objectives: To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD. Read more about this study

Who is it for?: Ages 40 to 100 years
Conditions the study is for: Advanced Parkinson's Disease
What is being tested?: Sinemet and IPX203
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 11 sitesUnited States
Study dates: 14 Nov 2016to 1 Aug 2017
Phase: Phase 2
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 40 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with idiopathic PD at age ≥ 40 years who are being chronically treated with stable regimens of CD-LD but experiencing motor complications.
Hoehn and Yahr Stages 2, 3, or 4
Montreal Cognitive Assessment (MoCA) score ≥ 24 at Screening Visit in "on" state.
For the 4 weeks prior to the Screening, the subject experiences daily "wearing-off" episodes with periods of bradykinesia and rigidity and experiences an "off" state upon awakening on most mornings by history.
Responsive to CD-LD therapy and currently being treated on a stable regimen with CD-LD for at least 4 weeks prior to Visit 1
Typically experiences an "on" response with the first dose of IR CD-LD of the day (by subject history).
By history, efficacy of the first morning dose of IR CD-LD lasts less than 4 hours

Who cannot join

History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy or proximal small-bowel resection.
Liver enzyme values ≥ 2.5 x the upper limit of normal; or history of severe hepatic impairment.
History of drug or alcohol abuse within the 12 months prior to Screening.
Received within 4 weeks of Visit 1 or planning to take during participation in the clinical study: any doses of a controlled-release (CR) LD apart from a single daily bedtime dose or any doses of Rytary, additional CD (eg, Lodosyn) or benserazide (eg, Serazide), or catechol-O-methyl transferase inhibitors (entacapone or tolcapone) or medications containing these inhibitors (Stalevo). Received within 4 weeks of Visit 1 or planning to take during participation in the clinical study: nonselective monoamine oxidase (MAO) inhibitors, apomorphine, or dopaminergic blocking agents including antiemetics.
History of psychosis within the past 10 years.
Treatment with any dopamine antagonist antipsychotics for the purposes of psychosis or bipolar disorder within the last 2 years.
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.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Investigator 106
Boca Raton, Florida, 33486
Investigator 109
Cleveland, Ohio, 44106
Site 103
Durham, North Carolina, 27705
Investigator 101
Farmington Hills, Michigan, 48334
Site 115
Kirkland, Washington, 98034
Investigator 110
Little Rock, Arkansas, 72205
Site 114
Little Rock, Arkansas, 72205
Investigator 112
Naples, Florida, 34102
Investigator 113
Port Charlotte, Florida, 33980
Investigator 104
Spokane, Washington, 99202
Site 108
Tampa, Florida, 33613

Other trials in United States

About this study

Official title: A Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease

Primary Objective:

To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD).

Secondary Objectives:

To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD.

To compare the efficacy of IPX203 with IR CD-LD following multiple doses.

To evaluate the safety of IPX203.

Read the detailed description

IPX203 is an investigational product containing CD-LD.

IPX203-B16-01 Study Design:

A randomized, open-label, rater-blinded, multicenter, 2-treatment, 2-period, multiple-dose crossover study.

Approximately 30 qualified IR CD-LD-experienced advanced PD subjects will be randomized.

The study duration will be approximately 8 weeks, including the screening period.

Conditions: Advanced Parkinson's Disease
Being tested: Sinemet, IPX203
Keywords: IPX203 (carbidopa-levodopa) Extended-Release capsules

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SinemetDrug
Also called IR CD-LD Tablets
Immediate Release Tablet containing carbidopa-levodopa flexible dosing
IPX203Drug
Also called IPX203 ER CD-LD Capsules
Extended Release capsules containing carbidopa-levodopa flexible dosing

Study groups in NCT03007888
Study group	Role	What they receive
IPX203 then Sinemet	Experimental	Participants first received IPX203 ER CD-LD Capsules for 15 days After a Washout Period of 7 days; participants then received Sinemet (IR CD-LD) Tablet for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours. Receives: Drug: Sinemet; Drug: IPX203
Sinemet then IPX203	Experimental	Participants first received Sinemet Capsules for 15 days After a Washout Period of 7 days; participants then received IPX203 ER CD-LD Capsules for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours. Receives: Drug: Sinemet; Drug: IPX203

What is being measured

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

Levodopa Cmax Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Measured: Day 1
Levodopa Tmax Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Measured: Day 1
Levodopa t1/2 Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Measured: Day 1
Levodopa AUCt Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Measured: Day 1
Levodopa AUCinf Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Measured: Day 1
Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Measured: Day 1
Carbidopa Cmax Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Measured: Day 1
Carbidopa Tmax Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Measured: Day 1
Carbidopa t1/2 Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Measured: Day 1
Carbidopa AUCt Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Measured: Day 1
Carbidopa AUCinf Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Measured: Day 1
Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Measured: Day 1
Levodopa Cmax Following First Dose on Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Measured: Day 15
Levodopa Tmax Following First Dose on Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Measured: Day 15
Levodopa AUCtau Following First Dose on Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Measured: Day 15
Carbidopa Cmax Following First Dose on Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Measured: Day 15
Carbidopa Tmax Following First Dose on Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Measured: Day 15
Carbidopa AUCtau Following First Dose on Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Measured: Day 15

Timeline

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

14 Nov 20161 Aug 2017

First posted2 Jan 2017 (estimated)
Study start14 Nov 2016
Primary completion1 Aug 2017
Study completion1 Aug 2017

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.
Other trials for Advanced 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03007888
Sponsor's protocol ID: IPX203-B16-01
Status last verified: Feb 2022
First submitted: 6 Dec 2016
Last updated: 6 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
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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Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease
ClinicalTrials.gov ID: NCT03007888
Acronym / sponsor ID: IPX203-B16-01
Conditions: Advanced Parkinson's Disease
Keywords: IPX203 (carbidopa-levodopa) Extended-Release capsules
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Impax Laboratories, LLCIndustry (pharma, biotech, devices)
Study start: 14 Nov 2016 (actual)
Primary completion: 1 Aug 2017 (actual)
Study completion: 1 Aug 2017 (actual)
First posted: 2 Jan 2017 (estimated)
Results: Posted 6 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary Objective:

To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD).

Secondary Objectives:

To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD.

To compare the efficacy of IPX203 with IR CD-LD following multiple doses.

To evaluate the safety of IPX203.

Detailed description

IPX203 is an investigational product containing CD-LD.

IPX203-B16-01 Study Design:

A randomized, open-label, rater-blinded, multicenter, 2-treatment, 2-period, multiple-dose crossover study.

Approximately 30 qualified IR CD-LD-experienced advanced PD subjects will be randomized.

The study duration will be approximately 8 weeks, including the screening period.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
IPX203 then Sinemet	Experimental	Drug: Sinemet, Drug: IPX203Participants first received IPX203 ER CD-LD Capsules for 15 days After a Washout Period of 7 days; participants then received Sinemet (IR CD-LD) Tablet for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours.
Sinemet then IPX203	Experimental	Drug: Sinemet, Drug: IPX203Participants first received Sinemet Capsules for 15 days After a Washout Period of 7 days; participants then received IPX203 ER CD-LD Capsules for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours.

Who may qualify

Ages: 40 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Diagnosed with idiopathic PD at age ≥ 40 years who are being chronically treated with stable regimens of CD-LD but experiencing motor complications.
Hoehn and Yahr Stages 2, 3, or 4
Montreal Cognitive Assessment (MoCA) score ≥ 24 at Screening Visit in "on" state.
For the 4 weeks prior to the Screening, the subject experiences daily "wearing-off" episodes with periods of bradykinesia and rigidity and experiences an "off" state upon awakening on most mornings by history.
Responsive to CD-LD therapy and currently being treated on a stable regimen with CD-LD for at least 4 weeks prior to Visit 1

Key exclusion criteria (7 listed)

History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy or proximal small-bowel resection.
Liver enzyme values ≥ 2.5 x the upper limit of normal; or history of severe hepatic impairment.
History of drug or alcohol abuse within the 12 months prior to Screening.
Received within 4 weeks of Visit 1 or planning to take during participation in the clinical study: any doses of a controlled-release (CR) LD apart from a single daily bedtime dose or any doses of Rytary, additional CD (eg, Lodosyn) or benserazide (eg, Serazide), or catechol-O-methyl transferase inhibitors (entacapone or tolcapone) or medications containing these inhibitors (Stalevo). Received within 4 weeks of Visit 1 or planning to take during participation in the clinical study: nonselective monoamine oxidase (MAO) inhibitors, apomorphine, or dopaminergic blocking agents including antiemetics.
History of psychosis within the past 10 years.

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
SinemetAlso: IR CD-LD TabletsImmediate Release Tablet containing carbidopa-levodopa flexible dosing	Drug	IPX203 then Sinemet, Sinemet then IPX203
IPX203Also: IPX203 ER CD-LD CapsulesExtended Release capsules containing carbidopa-levodopa flexible dosing	Drug	IPX203 then Sinemet, Sinemet then IPX203

Primary outcome

Levodopa Cmax Following First Dose on Day 1
Time frame: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Levodopa Tmax Following First Dose on Day 1
Time frame: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Levodopa t1/2 Following First Dose on Day 1
Time frame: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Levodopa AUCt Following First Dose on Day 1
Time frame: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Levodopa AUCinf Following First Dose on Day 1
Time frame: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1
Time frame: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Carbidopa Cmax Following First Dose on Day 1
Time frame: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Carbidopa Tmax Following First Dose on Day 1
Time frame: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Carbidopa t1/2 Following First Dose on Day 1
Time frame: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Carbidopa AUCt Following First Dose on Day 1
Time frame: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Carbidopa AUCinf Following First Dose on Day 1
Time frame: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1
Time frame: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Levodopa Cmax Following First Dose on Day 15
Time frame: Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Levodopa Tmax Following First Dose on Day 15
Time frame: Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Levodopa AUCtau Following First Dose on Day 15
Time frame: Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Carbidopa Cmax Following First Dose on Day 15
Time frame: Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Carbidopa Tmax Following First Dose on Day 15
Time frame: Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Carbidopa AUCtau Following First Dose on Day 15
Time frame: Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.

Results and safety

Results posted to the registry on 6 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IPX203 First Then Sinemet	15	14
Sinemet First Then IPX203	13	13

Primary outcome: Levodopa Cmax Following First Dose on Day 1

Time frame: Day 1. Mean (Standard Deviation). Unit: ng/mL

Measure	IPX203 n = 27	Sinemet n = 27
Value	2857.56 (1204.506)	2173.30 (1240.774)

Population analysed: Randomized subjects who completed both periods

Primary outcome: Levodopa Tmax Following First Dose on Day 1

Time frame: Day 1. Mean (Standard Deviation). Unit: hour

Measure	IPX203 n = 27	Sinemet n = 27
Value	2.07 (0.997)	0.94 (0.560)

Population analysed: Randomized subjects who completed both periods

Primary outcome: Levodopa t1/2 Following First Dose on Day 1

Time frame: Day 1. Mean (Standard Deviation). Unit: hour

Measure	IPX203 n = 27	Sinemet n = 27
Value	1.658 (0.4838)	1.420 (0.3194)

Population analysed: Randomized subjects who completed both periods

Primary outcome: Levodopa AUCt Following First Dose on Day 1

Time frame: Day 1. Mean (Standard Deviation). Unit: ng.h/mL

Measure	IPX203 n = 27	Sinemet n = 27
Value	12107.60 (5793.881)	3747.61 (1819.141)

Population analysed: Randomized subjects who completed both periods

Adverse events

Time frame: 15 days for each intervention plus 1 week washout up to a total of 37 days. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IPX203	1 of 28 (3.6%)	10 of 28 (35.7%)	0 of 28
Sinemet	0 of 27 (0%)	2 of 27 (7.4%)	0 of 27
Washout Period	1 of 28 (3.6%)	0 of 28 (0%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 Sinemet and IPX203 in people with Advanced 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 7 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 6 Jun 2022. 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?

Yes. Results are posted in the registry (first posted 6 Jun 2022). 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?

Levodopa Cmax Following First Dose on Day 1 (time frame: Day 1). The study lists 18 primary outcomes in all. 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 NCT03007888.

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 Jun 2022.