CClinicalTrials.gg
Sign In
CompletedNCT03007888Updated Jun 6, 2022Results posted

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

A Phase 2 interventional study of Sinemet and IPX203 in Advanced Parkinson's Disease, sponsored by Impax Laboratories, LLC. Completed at 11 sites in United States. Open to participants aged 40 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-06-06.

Sponsored by Impax Laboratories, LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
40 Years to 100 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Advanced Parkinson's Disease

Browse trials for

Keywords

  • IPX203 (carbidopa-levodopa) Extended-Release capsules
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 28 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Impax Laboratories, LLC is the lead sponsor of 20 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility will be determined at screening and Visit 1 of the study.

Inclusion criteria

Inclusion Criteria:

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    IPX203 then Sinemet

    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.

    Drug: Sinemet · Drug: IPX203

  • Experimental
    Sinemet then IPX203

    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.

    Drug: Sinemet · Drug: IPX203

Interventions

  • DrugSinemet

    Immediate Release Tablet containing carbidopa-levodopa flexible dosing

    Also known as: IR CD-LD Tablets

  • DrugIPX203

    Extended Release capsules containing carbidopa-levodopa flexible dosing

    Also known as: IPX203 ER CD-LD Capsules

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 1

  2. 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

    Time frame: Day 1

  3. 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

    Time frame: Day 1

  4. 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

    Time frame: Day 1

  5. 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

    Time frame: Day 1

  6. 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

    Time frame: Day 1

  7. 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

    Time frame: Day 1

  8. 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

    Time frame: Day 1

  9. 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

    Time frame: Day 1

  10. 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

    Time frame: Day 1

  11. 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

    Time frame: Day 1

  12. 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

    Time frame: Day 1

  13. 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.

    Time frame: Day 15

  14. 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.

    Time frame: Day 15

  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.

    Time frame: Day 15

  16. 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.

    Time frame: Day 15

  17. 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.

    Time frame: Day 15

  18. 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.

    Time frame: Day 15

07

Results

Posted Jun 6, 2022

Participant flow

A total of 39 subjects were screened at 10 study sites between November 8, 2016 and August 1, 2017

First Intervention (14 Days)
Participant flow — First Intervention (14 Days)
MilestoneIPX203 First Then SinemetSinemet First Then IPX203
Started1513
Completed1413
Not completed10
Withdrew: Adverse event10
Washout (7 Days)
Participant flow — Washout (7 Days)
MilestoneIPX203 First Then SinemetSinemet First Then IPX203
Started1413
Completed1413
Not completed00
Second Interventions (14 Days)
Participant flow — Second Interventions (14 Days)
MilestoneIPX203 First Then SinemetSinemet First Then IPX203
Started1413
Completed1413
Not completed00

Outcome measures

PrimaryLevodopa 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

Time frame:
Day 1
Reported as:
Mean · ng/mL
Levodopa Cmax Following First Dose on Day 1
ng/mLIPX203Sinemet
Levodopa Cmax Following First Dose on Day 12857.56 ± 1204.5062173.30 ± 1240.774
PrimaryLevodopa 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

Time frame:
Day 1
Reported as:
Mean · hour
Levodopa Tmax Following First Dose on Day 1
hourIPX203Sinemet
Levodopa Tmax Following First Dose on Day 12.07 ± 0.9970.94 ± 0.560
PrimaryLevodopa 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

Time frame:
Day 1
Reported as:
Mean · hour
Levodopa t1/2 Following First Dose on Day 1
hourIPX203Sinemet
Levodopa t1/2 Following First Dose on Day 11.658 ± 0.48381.420 ± 0.3194
PrimaryLevodopa 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

Time frame:
Day 1
Reported as:
Mean · ng.h/mL
Levodopa AUCt Following First Dose on Day 1
ng.h/mLIPX203Sinemet
Levodopa AUCt Following First Dose on Day 112107.60 ± 5793.8813747.61 ± 1819.141
PrimaryLevodopa 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

Time frame:
Day 1
Reported as:
Mean · ng.h/mL
Levodopa AUCinf Following First Dose on Day 1
ng.h/mLIPX203Sinemet
Levodopa AUCinf Following First Dose on Day 113968.57 ± 7606.9014308.37 ± 2123.057
PrimaryLevodopa 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

Time frame:
Day 1
Reported as:
Mean · Percentage
Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1
PercentageIPX203Sinemet
Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 188.965 ± 21.75830 ± 0
PrimaryCarbidopa 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

Time frame:
Day 1
Reported as:
Mean · ng/mL
Carbidopa Cmax Following First Dose on Day 1
ng/mLIPX203Sinemet
Carbidopa Cmax Following First Dose on Day 1500.35 ± 316.299151.50 ± 103.225
PrimaryCarbidopa 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

Time frame:
Day 1
Reported as:
Mean · hour
Carbidopa Tmax Following First Dose on Day 1
hourIPX203Sinemet
Carbidopa Tmax Following First Dose on Day 12.61 ± 0.6552.07 ± 0.675
PrimaryCarbidopa 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

Time frame:
Day 1
Reported as:
Mean · hour
Carbidopa t1/2 Following First Dose on Day 1
hourIPX203Sinemet
Carbidopa t1/2 Following First Dose on Day 12.015 ± 0.51591.969 ± 0.7187
PrimaryCarbidopa 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

Time frame:
Day 1
Reported as:
Mean · ng.h/mL
Carbidopa AUCt Following First Dose on Day 1
ng.h/mLIPX203Sinemet
Carbidopa AUCt Following First Dose on Day 11940.51 ± 1095.449436.63 ± 286.286
PrimaryCarbidopa 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

Time frame:
Day 1
Reported as:
Mean · ng.h/mL
Carbidopa AUCinf Following First Dose on Day 1
ng.h/mLIPX203Sinemet
Carbidopa AUCinf Following First Dose on Day 12239.61 ± 1232.234610.44 ± 407.305
PrimaryCarbidopa 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

Time frame:
Day 1
Reported as:
Mean · Percentage
Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1
PercentageIPX203Sinemet
Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1117.442 ± 43.41760 ± 0
PrimaryLevodopa 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.

Time frame:
Day 15
Reported as:
Mean · ng/mL
Levodopa Cmax Following First Dose on Day 15
ng/mLIPX203Sinemet
Levodopa Cmax Following First Dose on Day 152767.96 ± 1258.5252356.85 ± 1178.628
PrimaryLevodopa 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.

Time frame:
Day 15
Reported as:
Mean · hour
Levodopa Tmax Following First Dose on Day 15
hourIPX203Sinemet
Levodopa Tmax Following First Dose on Day 151.91 ± 1.2410.83 ± 0.439
PrimaryLevodopa 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.

Time frame:
Day 15
Reported as:
Mean · ng.h/ML
Levodopa AUCtau Following First Dose on Day 15
ng.h/MLIPX203Sinemet
Levodopa AUCtau Following First Dose on Day 1511213.76 ± 4887.2463879.39 ± 1744.328
PrimaryCarbidopa 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.

Time frame:
Day 15
Reported as:
Mean · ng/mL
Carbidopa Cmax Following First Dose on Day 15
ng/mLIPX203Sinemet
Carbidopa Cmax Following First Dose on Day 15478.66 ± 290.584145.67 ± 82.541
PrimaryCarbidopa 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.

Time frame:
Day 15
Reported as:
Mean · hour
Carbidopa Tmax Following First Dose on Day 15
hourIPX203Sinemet
Carbidopa Tmax Following First Dose on Day 152.52 ± 0.742.20 ± 0.639
PrimaryCarbidopa 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.

Time frame:
Day 15
Reported as:
Mean · ng.h/mL
Carbidopa AUCtau Following First Dose on Day 15
ng.h/mLIPX203Sinemet
Carbidopa AUCtau Following First Dose on Day 151892.39 ± 1017.537415.83 ± 279.487

Adverse events

Collected over 15 days for each intervention plus 1 week washout up to a total of 37 days. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
IPX2030/28 (0%)1/28 (3.6%)10/28 (35.7%)
Sinemet0/27 (0%)0/27 (0%)2/27 (7.4%)
Washout Period0/28 (0%)1/28 (3.6%)0/28 (0%)
Most frequent serious events
Most frequent serious events
EventIPX203SinemetWashout Period
HypertensionVascular disorders1/280/270/28
DiarrhoreaGastrointestinal disorders0/280/271/28
DehydrationMetabolism and nutrition disorders0/280/271/28
Atrial FibrillationCardiac disorders0/280/271/28
Most frequent other events
Showing 10 of 21
Most frequent other events
EventIPX203SinemetWashout Period
DyskinesiaNervous system disorders5/280/270/28
NauseaGastrointestinal disorders2/280/270/28
DizzinessNervous system disorders2/280/270/28
Abdominal PainGastrointestinal disorders0/281/270/28
DiarrhoeaGastrointestinal disorders0/281/270/28
Upper respiratiory track infectionInfections and infestations0/281/270/28
Dry MouthGastrointestinal disorders1/280/270/28
VomitingGastrointestinal disorders1/280/270/28
BronchitisInfections and infestations1/280/270/28
Urinary Tract infectionInfections and infestations1/280/270/28

Baseline characteristics

Subjects who were enrolled and randomized to 1 of 2 treatment sequences

Age, Categorical
Age, Categorical(Participants)All Study Participants
<=18 years0
Between 18 and 65 years13
>=65 years15
Age, Continuous
Age, Continuous(Years)All Study Participants
Mean66.43 ± 10.057
Sex: Female, Male
Sex: Female, Male(Participants)All Study Participants
Gender — Female12
Gender — Male16
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)All Study Participants
Hispanic or Latino1
Not Hispanic or Latino27
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Study Participants
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White26
More than one race2
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)All Study Participants
United States28
Age at Parkinson's disease onset
Age at Parkinson's disease onset(years)All Study Participants
Mean58.9 ± 11.8
Duration of Parkinson's disease
Duration of Parkinson's disease(years)All Study Participants
Mean7.5 ± 4.8

6 further baseline measures are reported on the registry.

08

Study locations

11 sites
  • Investigator 110
    Little Rock, Arkansas 72205, United States
  • Site 114
    Little Rock, Arkansas 72205, United States
  • Investigator 106
    Boca Raton, Florida 33486, United States
  • Investigator 112
    Naples, Florida 34102, United States
  • Investigator 113
    Port Charlotte, Florida 33980, United States
  • Site 108
    Tampa, Florida 33613, United States
  • Investigator 101
    Farmington Hills, Michigan 48334, United States
  • Site 103
    Durham, North Carolina 27705, United States
  • Investigator 109
    Cleveland, Ohio 44106, United States
  • Site 115
    Kirkland, Washington 98034, United States
  • Investigator 104
    Spokane, Washington 99202, United States
09

References and documents

Study documents

  • Study protocol · Oct 5, 2016
  • Statistical analysis plan · Sep 29, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03007888
Lead sponsor
Impax Laboratories, LLC
Responsible party
Sponsor
First posted
Jan 2, 2017
Start date
Nov 14, 2016
Primary completion
Aug 1, 2017
Completion
Aug 1, 2017
Results posted
Jun 6, 2022
Last update
Jun 6, 2022

Study contacts

Impax Study Director
study director · Impax Laboratories, LLC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Parkinson Disease→

Other studies from this sponsor

Impax Laboratories, LLC

Start the discussion