Drugs / carbidopa-levodopa

Trials 13

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT03761004 Jan → Sep 2019 — Hong Kong WD Pharmaceutical Co., Limited Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT06587217 Oct 2024 → Apr 2025 parkinsonian disorder University of Michigan Completed No outcome recorded
Phase 1/2 NCT06219915 Mar → May 2024 parkinsonian disorder University of Michigan Completed No outcome recorded
Phase 25 trials
Phase 2 NCT05087914 Nov 2021 → Dec 2023 — Northwestern University Withdrawn No outcome recorded Stop: Enrollment
Phase 2 NCT05463367 Jan 2021 → Jun 2025 overdue chronic pain syndrome, opiate dependence, substance abuse Northwestern University Active not recruiting No outcome recorded
Phase 2 NCT03451500 Jul 2018 → Oct 2019 age-related macular degeneration Snyder, Robert W., M.D., Ph.D., P.C. Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT03023059 May 2017 → Mar 2020 age-related macular degeneration Snyder, Robert W., M.D., Ph.D., P.C. Completed No outcome recorded
Phase 2 NCT00869791 Nov 2008 → Jun 2009 Parkinson disease Impax Laboratories, LLC Completed No outcome recorded
Phase 32 trials · 2 met primary
Phase 3 NCT03670953 Nov 2018 → Jun 2021 Parkinson disease Impax Laboratories, LLC Completed Met primary
Phase 3 NCT00974974 Sep 2009 → Jan 2011 Parkinson disease Impax Laboratories, LLC Completed Met primary
Phase 41 trial
Phase 4 NCT00590122 Oct 2006 → Oct 2008 Parkinson disease Baylor College of Medicine Completed No outcome recorded
Phase not applicable2 trials
— NCT01528592 Jun 2011 → Jul 2012 Parkinson disease Northwestern University Completed No outcome recorded
— NCT00715520 Apr 2007 → Sep 2016 ischemic stroke Emory University Completed No outcome recorded
Comparator or background therapy3 trials
Phase 2 NCT05285683 Comparator Jan 2024 → Dec 2027 expected chronic pain syndrome University of Rochester Recruiting No outcome recorded
Phase 2 NCT05962957 Comparator Aug 2023 → Sep 2024 Parkinson disease Mostafa Bahaa Completed No outcome recorded
Phase 2 NCT03576638 Comparator Jul 2018 → Jan 2019 Parkinson disease Intec Pharma Ltd. Unknown No outcome recorded

Press releases naming this drug 30 releases

DateIssuerRelease
2018-10-24 Impax Laboratories, LLC Amneal Announces Issuance of New Patent for IPX203, an Investigational Extended-Release Formulation of Carbidopa-Levodopa amneal.com ↗
2018-05-07 Impax Laboratories, LLC Amneal Initiates Phase 3 Study for IPX203, an Investigational Extended-Release Formulation of Carbidopa-Levodopa (CD-LD) in Advanced Parkinson's Disease Patients amneal.com ↗
2014-11-06 Impax Laboratories, LLC Impax Submits Marketing Authorization Application to EMA for IPX066 (Carbidopa-Levodopa) Extended-Release Capsules amneal.com ↗
2014-04-11 Impax Laboratories, LLC Impax Pharmaceuticals Resubmits New Drug Application for RYTARY™ (Carbidopa and Levodopa) Extended-Release Capsules (IPX066) amneal.com ↗
2013-04-29 GlaxoSmithKline GlaxoSmithKline and Impax Pharmaceuticals terminate their collaboration on IPX066 gsk.com ↗
2013-04-29 Impax Laboratories, LLC Impax Pharmaceuticals and GlaxoSmithKline Terminate Their Collaboration on IPX066 (RYTARYTM) amneal.com ↗
2013-03-19 Impax Laboratories, LLC Impax Pharmaceuticals Announces Presentation of RYTARYTM (IPX066) (Carbidopa and Levodopa) Extended-Release Capsules Phase III and Open-Label Extension Data at the American Academy of Neurology 2013 Annual Meeting amneal.com ↗
2013-03-15 Impax Laboratories, LLC RYTARYTM (IPX066) (Carbidopa and Levodopa) Extended-Release Capsules Phase III and Open-Label Extension Data to be Presented at the American Academy of Neurology Conference amneal.com ↗
2013-01-21 Impax Laboratories, LLC FDA Issues Complete Response Letter for RYTARY™ (Carbidopa and Levodopa) Extended-Release Capsules (IPX066) New Drug Application amneal.com ↗
2012-04-18 Impax Laboratories, LLC Data from ASCEND-PD Phase III Study of IPX066 to be Presented at the American Academy of Neurology Conference amneal.com ↗
2012-02-23 Impax Laboratories, LLC FDA Accepts Impax Pharmaceuticals NDA Filing for IPX066 for the Treatment of Idiopathic Parkinson’s Disease amneal.com ↗
2011-12-21 Impax Laboratories, LLC Impax Pharmaceuticals Submits New Drug Application for IPX066 in Parkinson’s Disease amneal.com ↗

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 16 sources stand behind the page.

FieldValueCited text
Known as carbidopa/levodopa “An Open Label Phase 2 Study to Assess the Pharmacokinetics of the Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Patients With Parkinson's Disease” NCT03576638 ↗
16

“OBJECTIVE: To assess the efficacy and safety of IPX203 vs immediate-release carbidopa-levodopa in patients with Parkinson disease who are experiencing motor fluctuations.” PMID 37578800 ↗ Oct 2023

“oral administration of pro-dopaminergic medications carbidopa/levodopa (CD/LD) and methylphenidate will modulate the brain signature of chronic pain” NCT05285683 ↗

“BACKGROUND: IPX066 is an extended-release (ER) oral formulation of carbidopa-levodopa (CD-LD).” PMID 30425824 ↗ Oct 2018

“experimental drug product: extended-release carbidopa-levodopa capsules” NCT00869791 ↗

“Carbidopa-levodopa (Sinemet)at subjects current stable dose” NCT00590122 ↗

NCT06219915 ↗

NCT05463367 ↗

NCT05087914 ↗

NCT00715520 ↗

NCT03451500 ↗

Show 6 more sources

Known as CD/LD “oral administration of pro-dopaminergic medications carbidopa/levodopa (CD/LD) and methylphenidate will modulate the brain signature of chronic pain” NCT05285683 ↗
1

“BACKGROUND: IPX066 is an extended-release (ER) oral formulation of carbidopa-levodopa (CD-LD).” PMID 30425824 ↗ Oct 2018

Known as IPX066 “BACKGROUND: IPX066 is an extended-release (ER) oral formulation of carbidopa-levodopa (CD-LD).” PMID 30425824 ↗ Oct 2018
Known as IR CD-LD “Two-phase 3 studies of ER CD-LD vs. immediate-release (IR) CD-LD (ADVANCE-PD) and vs. CD-LD + entacapone (CLE; ASCEND-PD) in subjects with advanced PD included a 6-week,...” PMID 30425824 ↗ Oct 2018
Known as Sinemet “Carbidopa-levodopa (Sinemet)at subjects current stable dose” NCT00590122 ↗
1

“Immediate release CD/LD (Sinemet)” NCT03576638 ↗

Route Oral “conventional immediate release oral levodopa” NCT00590122 ↗