Parkinson's DiseasePhase 2NCT00869791

A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa

A Phase 2 study testing IPX066 and IR CD-LD in people with Parkinson's Disease, run by Impax Laboratories, LLC at 1 site 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

This study evaluated the pharmacokinetics, motor effects, and assessed the safety of IPX066 compared with an immediate-release cabridopa-levodopa formulation in subjects with advanced 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?: IPX066 and IR CD-LD
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited States
Study dates: Nov 2008to Jun 2009
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 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female diagnosed with idiopathic PD, without any known cause for Parkinsonism.
If female and of childbearing potential, subject should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier). The subject must agree to take every precaution to ensure that pregnancy will not occur during the study.
At least 30 years old at the time of diagnosis of PD.
Mini Mental State Examination (MMSE) ≥ 26 at Screening Visit.
A responder to LD and currently being chronically treated with stable dosage of commercially available standard, orally disintegrating, or controlled-release CD LD for at least 1 month.
Must have predictable fluctuations between "on" and "off" states.

Show all 9Show fewer

Hoehn and Yahr Stage I-IV when "on".
Able to provide informed consent and willing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization.
Able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections.

Who cannot join

Pregnant or breastfeeding.
Diagnosed with atypical parkinsonism.
History, physical findings or laboratory results suggesting a diagnosis other than PD.
Allergic or nonresponsive to previous CD-LD therapy.
Any medical (e.g., liver or kidney impairment, peptic ulcer) or condition/history that, in the Investigator's opinion, may jeopardize the subject's safety.
Exposure to any investigational agent within 30 days prior to Visit 1.
Donated blood or plasma within 28 days.
Had prior functional neurosurgical treatment for PD (ablation or Deep Brain Stimulation).

Trial locations and contacts

1 site in 1 country.

United States1 site

IMPAX Laboratories
Hayward, California, 94544

Other trials in United States

About this study

Read the detailed description

This was a randomized, multicenter, open-label, single and multiple oral dose, two-treatment, two-period, crossover study in LD-experienced subjects with Parkinson's disease (PD). Subjects received 7 days of one treatment (IPX066 or IR CD-LD) followed by an approximate 7-day washout period followed by another 7 days of the other treatment (IR CD-LD or IPX066). During the approximate 7-day washout period, subjects took their prestudy CD-LD regimen. Pharmacokinetic and efficacy/pharmacodynamic measurements were done on Days 1 and 8. Safety measures (electrocardiograms [ECGs], clinical laboratory tests, vital signs, adverse events [AEs], and concomitant medications) were evaluated over the course of the study.

Conditions: Parkinson's Disease
Being tested: IPX066, IR CD-LD
Keywords: Parkinson's
Medical subject headings: Parkinson Disease

What participants receive

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

IPX066Drug
Also called ER CD-LD
experimental drug product: extended-release carbidopa-levodopa capsules
IR CD-LDDrug
Also called immediate-release carbidopa-levodopa
active comparator: immediate-release carbidopa-levodopa capsules

Study groups in NCT00869791
Study group	Role	What they receive
Sequence 1	Other	Treatment Period 1: IPX066 - 7 days; Washout Period - 7 days; Treatment Period 2: IR CD-LD- 7 days Receives: Drug: IPX066; Drug: IR CD-LD
Sequence 2	Other	Treatment Period 1: IR CD-LD - 7 days; Washout period - 7 days; Treatment Period 2: IPX066- 7 days Receives: Drug: IPX066; Drug: IR CD-LD

What is being measured

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

Pharmacokinetics Measurements to Determine Cmax for Carbidopa (CD) and Levodopa (LD) Plasma Concentrations From Samples Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Both Treatment Arms.
For both treatment arms: Sequence 1 (IPX066, Washout, then IR CD-LD) and Sequence 2 (IR CD-LD, Washout, IPX066), blood samples for measurement of LD and CD plasma concentrations were collected pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, and 8 hours after dosing on Day 1 (referred to as Single-Dose data); and at pre-dose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing on Day 8 (referred to as Multiple-Dose data). Maximum (peak) drug concentration (Cmax in nanograms/milliliter) was estimated using Single-Dose data and Multiple-Dose data.
Measured: Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm 2 (CD-LD IR first, washout, then IPX066)
Pharmacokinetics Measurements to Determine Tmax for Levodopa and Carbidopa Plasma Concentrations From Samples Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Both Treatment Arms.
For both treatment arms: Sequence 1 (IPX066, Washout, then IR CD-LD) and Sequence 2 (IR CD-LD, Washout, IPX066), blood samples for measurement of LD and CD plasma concentrations were collected pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, and 8 hours after dosing on Day 1 (referred to as Single-Dose data); and at pre-dose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing on Day 8 (referred to as Multiple-Dose data). Time of maximum drug concentration (Tmax in hours) was estimated using Single-Dose data and Multiple-Dose data.
Measured: Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm2 (CD-LD IR first, washout, then IPX066
Pharmacokinetics Measurements to Determine Area Under the Concentration-time Curve for the Dosing Interval for LD and CD Concentrations From Blood Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Treatment Arms.
For both treatment arms: Sequence 1 (IPX066, Washout, then IR CD-LD) and Sequence 2 (IR CD-LD, Washout, IPX066), blood samples for measurement of LD and CD plasma concentrations were collected pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, and 8 hours after dosing on Day 1 (referred to as Single-Dose data); and at pre-dose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing on Day 8 (referred to as Multiple-Dose data). Area under the concentration-time curve for the dosing interval (AUC Tau) in hour*nanogram/milliliter was estimated using Single-Dose data and Multiple-Dose data.
Measured: Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm2 (CD-LD IR first, washout, then IPX066

Secondary outcomes (4)

8-Hour Efficacy Using Day 1 Tapping
Improvement in "Tapping: has been used as a surrogate endpoint for assessing subject being "On". Finger Tapping: the number of times the subject could tap two counter keys 20 cm apart alternately in 1 minute with the most affected arm assessed every 30 minutes on Day 1. Subjects performed the 60-second tapping measurement three times prior to dosing in the clinic, and at half-hour intervals through the 8-hour measurement period on Day 1 of each treatment period. More hours "On" during treatment represented better outcome. For the Tapping measurement, the protocol defined a 20% change from the average of the predose measurements as the time to "On." Each half-hour interval counted as 0.5 hour. Any measurement below a 20% improvement was considered time "Not On." If patient required redosing then primary analyses adjusted for redosing in calculating the results.
Measured: Day 1 of each treatment period - three times prior to dosing in the clinic, and at half-hour intervals through the 8-hour measurement period
8-Hour Efficacy Using Day 1 Unified Parkinson's Disease Rating Scale Part III Score
To determine efficacy on Day 1 the UPDRS (unified Parkinson's disease rating) Part III score, a clinician-scored measure of motor function, was collected immediately predose and 1, 2, 3, 4, 5, 6, 7 and 8 h post dose. The UPDRS Part III motor exam analyzes multiple motor functions like speech, facial expression, tremor, rigidity, movement, posture, gait etc. Each parameter is assigned values from 0 to 4, with 0 being normal and 4 being the most affected. The total range is 0 - 108, with lower scores indicating a better outcome.The average of post dose was calculated for day 1.
Measured: Pre dosing and at hourly intervals through the 8-hour measurement period on day 1
Result Summary of Day 1 Dyskinesia Evaluated by Investigator Assessment for Each Treatment Period
To determine 8h efficacy on Day 1 the on site investigator assessments of "ON", "OFF" and "state of dyskinesia" for each subject was collected predose (-1, -0.5, and 0 hours) every 30 min for up to 8 hours after dosing . For all subjects duration of (1) OFF time (2) ON time without dyskinesia, (3) ON time with non-troublesome dyskinesia and (4) ON time with troublesome dyskinesia was calculated for both treatments. Definition of "ON" was based on a 20% change from predose measure, and the results were analyzed in the standard manner of a two way crossover design. The trial inclusion criteria included ability of subject to differentiate "ON" state from "OFF" state per investigator's assessment.
Measured: Predose and then every 30 min upto 8 h after dosing on Day of 1 of each treatment period
"Off" Time Hours Reported by Subjects Using Parkinson's Patient Diary
Subjects recorded state of "OFF" time using the Parkinson's Patient Diary
Measured: Last 3 days of each treatment period, every 30 minutes over a 24-hour day beginning at 6:00 AM

Timeline

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

Nov 2008Jun 2009

First posted26 Mar 2009 (estimated)
Study startNov 2008
Primary completionJun 2009
Study completionJun 2009

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.
Publications (1)Papers the sponsor has linked to this study.
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: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00869791
Sponsor's protocol ID: IPX066-B08-11
Status last verified: Mar 2017
First submitted: 24 Mar 2009
Last updated: 8 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Hauser RA, Ellenbogen AL, Metman LV, Hsu A, O'Connell MJ, Modi NB, Yao HM, Kell SH, Gupta SK. Crossover comparison of IPX066 and a standard levodopa formulation in advanced Parkinson's disease. Mov Disord. 2011 Oct;26(12):2246-52. doi: 10.1002/mds.23861. Epub 2011 Jul 13.
PubMed 21755537

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?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa
ClinicalTrials.gov ID: NCT00869791
Acronym / sponsor ID: IPX066-B08-11
Conditions: Parkinson's Disease
Keywords: Parkinson's
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Impax Laboratories, LLCIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 26 Mar 2009 (estimated)
Results: Posted 31 Mar 2017

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sequence 1	Other	Drug: IPX066, Drug: IR CD-LDTreatment Period 1: IPX066 - 7 days; Washout Period - 7 days; Treatment Period 2: IR CD-LD- 7 days
Sequence 2	Other	Drug: IPX066, Drug: IR CD-LDTreatment Period 1: IR CD-LD - 7 days; Washout period - 7 days; Treatment Period 2: IPX066- 7 days

Who may qualify

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

Key inclusion criteria (9 listed)

Male or female diagnosed with idiopathic PD, without any known cause for Parkinsonism.
If female and of childbearing potential, subject should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier). The subject must agree to take every precaution to ensure that pregnancy will not occur during the study.
At least 30 years old at the time of diagnosis of PD.
Mini Mental State Examination (MMSE) ≥ 26 at Screening Visit.
A responder to LD and currently being chronically treated with stable dosage of commercially available standard, orally disintegrating, or controlled-release CD LD for at least 1 month.

Key exclusion criteria (8 listed)

Pregnant or breastfeeding.
Diagnosed with atypical parkinsonism.
History, physical findings or laboratory results suggesting a diagnosis other than PD.
Allergic or nonresponsive to previous CD-LD therapy.
Any medical (e.g., liver or kidney impairment, peptic ulcer) or condition/history that, in the Investigator's opinion, may jeopardize the subject's safety.

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
IPX066Also: ER CD-LDexperimental drug product: extended-release carbidopa-levodopa capsules	Drug	Sequence 1, Sequence 2
IR CD-LDAlso: immediate-release carbidopa-levodopaactive comparator: immediate-release carbidopa-levodopa capsules	Drug	Sequence 1, Sequence 2

Primary outcome

Pharmacokinetics Measurements to Determine Cmax for Carbidopa (CD) and Levodopa (LD) Plasma Concentrations From Samples Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Both Treatment Arms.
Time frame: Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm 2 (CD-LD IR first, washout, then IPX066)
For both treatment arms: Sequence 1 (IPX066, Washout, then IR CD-LD) and Sequence 2 (IR CD-LD, Washout, IPX066), blood samples for measurement of LD and CD plasma concentrations were collected pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, and 8 hours after dosing on Day 1 (referred to as Single-Dose data); and at pre-dose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing on Day 8 (referred to as Multiple-Dose data). Maximum (peak) drug concentration (Cmax in nanograms/milliliter) was estimated using Single-Dose data and Multiple-Dose data.
Pharmacokinetics Measurements to Determine Tmax for Levodopa and Carbidopa Plasma Concentrations From Samples Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Both Treatment Arms.
Time frame: Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm2 (CD-LD IR first, washout, then IPX066
For both treatment arms: Sequence 1 (IPX066, Washout, then IR CD-LD) and Sequence 2 (IR CD-LD, Washout, IPX066), blood samples for measurement of LD and CD plasma concentrations were collected pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, and 8 hours after dosing on Day 1 (referred to as Single-Dose data); and at pre-dose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing on Day 8 (referred to as Multiple-Dose data). Time of maximum drug concentration (Tmax in hours) was estimated using Single-Dose data and Multiple-Dose data.
Pharmacokinetics Measurements to Determine Area Under the Concentration-time Curve for the Dosing Interval for LD and CD Concentrations From Blood Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Treatment Arms.
Time frame: Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm2 (CD-LD IR first, washout, then IPX066
For both treatment arms: Sequence 1 (IPX066, Washout, then IR CD-LD) and Sequence 2 (IR CD-LD, Washout, IPX066), blood samples for measurement of LD and CD plasma concentrations were collected pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, and 8 hours after dosing on Day 1 (referred to as Single-Dose data); and at pre-dose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing on Day 8 (referred to as Multiple-Dose data). Area under the concentration-time curve for the dosing interval (AUC Tau) in hour*nanogram/milliliter was estimated using Single-Dose data and Multiple-Dose data.

4 secondary outcomes

8-Hour Efficacy Using Day 1 Tapping
Time frame: Day 1 of each treatment period - three times prior to dosing in the clinic, and at half-hour intervals through the 8-hour measurement period
8-Hour Efficacy Using Day 1 Unified Parkinson's Disease Rating Scale Part III Score
Time frame: Pre dosing and at hourly intervals through the 8-hour measurement period on day 1
Result Summary of Day 1 Dyskinesia Evaluated by Investigator Assessment for Each Treatment Period
Time frame: Predose and then every 30 min upto 8 h after dosing on Day of 1 of each treatment period
"Off" Time Hours Reported by Subjects Using Parkinson's Patient Diary
Time frame: Last 3 days of each treatment period, every 30 minutes over a 24-hour day beginning at 6:00 AM

Results and safety

Results posted to the registry on 31 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IPX066 First (7 Days), Washout (7 Days) Then IR CD-LD (7 Days)	14	14
IR CD-LD First ( 7 Days), Washout (7 Days) Then IPX066 (7days)	13	13

Primary outcome: Pharmacokinetics Measurements to Determine Cmax for Carbidopa (CD) and Levodopa (LD) Plasma Concentrations From Samples Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Both Treatment Arms.

Time frame: Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm 2 (CD-LD IR first, washout, then IPX066). Mean (Standard Deviation). Unit: nanogram/milliliter

Measure	IPX066 n = 27	IR CD-LD n = 27
CD Cmax, Single-Dose	238.852 (91.004)	146.848 (58.787)
CD Cmax, Multiple-Dose	313.222 (167.924)	167.515 (51.204)
LD Cmax, Single-Dose	3000.000 (1301.608)	2356.444 (1080.541)
LD Cmax, Multiple-Dose	3807.037 (1547.120)	2761.852 (1002.984)

Population analysed: The study was designed to assess the single and multiple-dose PK and PD of IPX066 and IR CD-LD in subjects with advanced PD.14 subjects first received IPX066 (Period 1), then IR CD-LD (Period 2). 13 Subjects first received IR CD-LD (Period 1), then IPX066 (Period 2). All 27 subjects that were treated in the study were included in the PK analyses.

Primary outcome: Pharmacokinetics Measurements to Determine Tmax for Levodopa and Carbidopa Plasma Concentrations From Samples Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Both Treatment Arms.

Time frame: Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm2 (CD-LD IR first, washout, then IPX066. Mean (Standard Deviation). Unit: Hours

Measure	IPX066 n = 27	IR CD-LD n = 27
CD Tmax Single-Dose	2.944 (0.5604)	2.296 (0.6086)
CD Tmax Multiple-Dose	3.815 (2.6390)	5.685 (3.5711)
LD Tmax Single-Dose	2.037 (1.0735)	0.870 (0.4921)
LD Tmax Multiple-Dose	4.407 (3.7597)	3.611 (4.2161)

Population analysed: The study was designed to assess the single and multiple-dose PK and PD of IPX066 and IR CD-LD in subjects with advanced PD. 14 subjects first received IPX066 (Period 1), then IR CD-LD (Period 2). 13 Subjects first received IR CD-LD (Period 1), then IPX066 (Period 2). All 27 subjects that were treated in the study were included in the PK analyses.

Primary outcome: Pharmacokinetics Measurements to Determine Area Under the Concentration-time Curve for the Dosing Interval for LD and CD Concentrations From Blood Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Treatment Arms.

Measure	IPX066 n = 27	IR CD-LD n = 27
CD AUC Tau, Single-Dose	917.067 (373.9147)	401.694 (177.8239)
CD AUC Tau, Multiple-Dose	1344.436 (818.1622)	449.584 (273.8498)
LD AUC Tau, Single-Dose	10902.194 (4619.2284)	3881.298 (1586.9059)
LD AUC Tau, Multiple-Dose	13903.380 (6990.0405)	4167.151 (1799.2567)

Population analysed: The study was designed to assess the single and multiple-dose PK and PD of IPX066 and IR CD-LD in subjects with advanced PD. 14 subjects first received IPX066 (Period 1), then IR CD-LD (Period 2). 13 Subjects first received IR CD-LD (Period 1), then IPX066 (Period 2). All 27 subjects that were treated in the study were included in the PK analyses.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: At each of the 4 study visits and follow-up with the subject by phone within 1 week of study exit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IPX066	0 of 27 (0%)	3 of 27 (11.1%)	Not reported
CD-LD IR	0 of 27 (0%)	3 of 27 (11.1%)	Not reported

Limitations and caveats (from the sponsor): The limitations of this study include its relatively small size, multiple statistical testing, short study durations, and open-label design.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21755537Hauser RA, Ellenbogen AL, Metman LV, Hsu A, O'Connell MJ, Modi NB, Yao HM, Kell SH, Gupta SK. Crossover comparison of IPX066 and a standard levodopa formulation in advanced Parkinson's disease. Mov Disord. 2011 Oct;26(12):2246-52. doi: 10.1002/mds.23861. Epub 2011 Jul 13.
PebMed AbstractLink provided by the sponsor.
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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IPX066 and IR CD-LD in people with Parkinson's Disease, run by Impax Laboratories, LLC at 1 site 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 9 inclusion and 8 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 8 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 1 site 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 31 Mar 2017). 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?

Pharmacokinetics Measurements to Determine Cmax for Carbidopa (CD) and Levodopa (LD) Plasma Concentrations From Samples Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Both Treatment Arms. (time frame: Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm 2 (CD-LD IR first, washout, then IPX066)). The study lists 3 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 NCT00869791, which also lists 1 linked publication.

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 8 Nov 2019.