20 completed, 1 recruiting. 11 Phase 3, 8 Phase 2, 2 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 11 | Completed 11 |
| Phase 2 | 8 | Completed 8 |
| Phase 1 | 2 | Completed 2 |
| Phase 4 | 1 | Recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of CREXONT (Carbidopa and Levodopa) Extended-Release Capsules in Participants With Parkinson's Disease CREXONT ER - Parkinson Disease | Phase 4 | Recruiting | Impax Laboratories, LLC | 220 | 2025-02-12 | 2025-08-24 |
| A TQT Study to Evaluate the Electrocardiographic Effects of Carbidopa in Healthy Subjects Carbidopa capsule, Moxifloxacin Tablets, USP, Placebo - Cardiac Repolarization in Healthy Subjects | Phase 1 | Completed | Impax Laboratories, LLC | 35 | 2023-10-30 | 2024-03-05 |
| Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations IPX203 - Parkinson Disease | Phase 3 | Completed | Impax Laboratories, LLC | 419 | 2019-04-03 | 2023-07-13 |
| A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations IR CD-LD, IPX203 ER CD-LD, Placebo Matching IPX203 - Parkinson's Disease (Disorder) | Phase 3 | Completed | Impax Laboratories, LLC | 630 | 2018-11-06 | 2023-02-09 |
| Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE Placebo ZNS, ZNS - Migraine | Phase 3 | Completed | Impax Laboratories, LLC | 374 | 2017-11-27 | 2021-01-11 |
| A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease Sinemet, IPX203 - Advanced Parkinson's Disease | Phase 2 | Completed | Impax Laboratories, LLC | 28 | 2016-11-14 | 2022-06-06 |
| Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy estrace cream (Perrigo), estrace cream (Reference), Placebo cream - Atrophy | Phase 3 | Completed | Padagis LLC | 695 | 2016-05-01 | 2021-11-02 |
| A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease CD-LD IR, IPX203 180 mg, IPX203 270 mg - Parkinson's Disease | Phase 2 | Completed | Impax Laboratories, LLC | 26 | 2015-11-01 | 2019-11-06 |
| Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS) IPX159, Placebo - Restless Legs Syndrome | Phase 2 | Completed | Impax Laboratories, LLC | 159 | 2011-11-01 | 2017-02-01 |
| Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study IPX066 - Parkinson's Disease | Phase 3 | Completed | Impax Laboratories, LLC | 43 | 2011-08-01 | 2019-11-07 |
| A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 IPX066, CLE - Parkinson's Disease | Phase 3 | Completed | Impax Laboratories, LLC | 110 | 2010-05-01 | 2019-10-29 |
| An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease IPX066 95 mg, IPX066 145 mg, IPX066 195 mg - Parkinson's Disease | Phase 3 | Completed | Impax Laboratories, LLC | 617 | 2010-03-01 | 2019-11-08 |
| A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD). IPX066, IR CD-LD - Parkinson's Disease | Phase 3 | Completed | Impax Laboratories, LLC | 471 | 2009-09-01 | 2020-08-11 |
| A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease Placebo, IPX066 95 mg LD, IPX066 145 mg LD - Parkinson's Disease | Phase 3 | Completed | Impax Laboratories, LLC | 381 | 2009-04-01 | 2019-10-29 |
| A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis IPX056, Baclofen IR, Placebo IPX056 - Spasticity, Multiple Sclerosis | Phase 2 | Completed | Impax Laboratories, LLC | 23 | 2009-04-01 | 2019-11-06 |
| A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa IPX066, IR CD-LD - Parkinson's Disease | Phase 2 | Completed | Impax Laboratories, LLC | 27 | 2008-11-01 | 2019-11-08 |
| IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis IPX056 20 mg, IPX056 40 mg, Encapsulated Baclofen 20 mg - Multiple Sclerosis | Phase 3 | Completed | Impax Laboratories, LLC | 173 | 2007-06-01 | 2019-11-06 |
| Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease IPX054 200 mg, IPX054 250 mg, CD-LD IR - Idiopathic Parkinson's Disease | Phase 2 | Completed | Impax Laboratories, LLC | 16 | 2006-01-01 | 2019-10-29 |
| Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease IPX054 200 mg, CD-LD IR, IPX054 Placebo - Parkinson's Disease | Phase 2 | Completed | Impax Laboratories, LLC | 12 | 2005-11-01 | 2019-10-29 |
| Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease IPX054 100 mg, IPX054 150 mg, IPX054 200 mg - Idiopathic Parkinson's Disease | Phase 1 / Phase 2 | Completed | Impax Laboratories, LLC | 12 | 2005-10-01 | 2019-10-29 |
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Parkinson Disease (13) · Headache (2) · Migraine Disorders (2) · Multiple Sclerosis (2) · Muscle Spasticity (2) · Atrophy (1) · Pain (1) · Restless Legs Syndrome (1)
carbidopa, levodopa drug combination (9) · Carbidopa (1) · Drugs, Generic (1) · Stalevo (1) · zolmitriptan (1)
United States (20) · Germany (5) · Canada (4) · France (4) · Poland (4) · Spain (4) · Ukraine (4) · Estonia (3) · Italy (3) · Latvia (3) · Romania (3) · Czechia (2) · Lithuania (2) · United Kingdom (2)
PMID 30425824, PMID 23485610, PMID 28131167, PMID 37578800
2018 (2)