NCT00253084 is a Phase 2 clinical trial of IPX054 200 mg in Parkinson's Disease, sponsored by Impax Laboratories, LLC.

Who is sponsoring NCT00253084?

NCT00253084 is sponsored by Impax Laboratories, LLC.

What drugs are being tested in NCT00253084?

Interventions in NCT00253084: IPX054 200 mg, CD-LD IR, IPX054 Placebo, CD-LD IR Placebo.

What condition does NCT00253084 study?

NCT00253084 studies Parkinson's Disease.

Is NCT00253084 still recruiting?

NCT00253084 is currently completed. Last updated 25 October 2019.

Last reviewed 2019-10-25 · How we verify

NCT00253084

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease

Completed Phase 2 Last updated 25 October 2019

What this trial tests

Phase 2 trial testing IPX054 200 mg in Parkinson's Disease in 12 participants. Completed in 1 December 2007.

Timeline

1 November 2005

Primary endpoint
1 December 2007

1 December 2007

Quick facts

Lead sponsor	Impax Laboratories, LLC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	12
Start date	1 November 2005
Primary completion	1 December 2007
Estimated completion	1 December 2007
Sites	2 locations across United States

Drugs / interventions tested

IPX054 200 mg — full drug profile →
CD-LD IR — full drug profile →
IPX054 Placebo — full drug profile →
CD-LD IR Placebo

Conditions studied

Parkinson's Disease — all drugs for Parkinson's Disease →

Sponsor

Impax Laboratories, LLC — full company profile →

Who can join

30 and older, any sex, with Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

"ON" time without disabling dyskinesias
Time frame: 2 weeks

Sponsor's own description

The purpose of this study is to compare the clinical efficacy of IPX054 to immediate-release carbidopa-levodopa in subjects with Parkinson's disease.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Parkinson's Disease

Currently open trials in the same condition.

NCT07371338 — Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients · Phase 1 · recruiting
NCT07330258 — A US Study That Observes How Parkinson's Disease Changes Over Time in Patients Who Still Have Movement Symptoms Despite · recruiting
NCT07384429 — Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease · Phase 4 · recruiting
NCT07384442 — Effects of Targeted Temporal Interference Stimulation of Cerebellar Nuclei on Tremor and Gait Disturbance in Parkinson's · NA · recruiting
NCT06562569 — Non-invasive VNS for PD Gait · NA · recruiting

Other Impax Laboratories, LLC trials

Trials by the same sponsor.

NCT06161220 — A TQT Study to Evaluate the Electrocardiographic Effects of Carbidopa in Healthy Subjects · Phase 1 · completed
NCT03877510 — Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants W · Phase 3 · completed
NCT03670953 — A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations · Phase 3 · completed
NCT03275922 — Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE · Phase 3 · completed
NCT03007888 — A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00253084 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Impax Laboratories, LLC
Last refreshed: 25 October 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00253084.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing