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Clinical Trials/EUCTR2018-002234-21-GB
EUCTR2018-002234-21-GBActive, not recruitingPhase 1

AN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS

Impax Laboratories, LLC0 sites300 target enrollmentStarted: July 4, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
300
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Successfully completed Study IPX203-B16-02;
  • •2. Able to provide written informed consent prior to the conduct of any study-specific procedures;
  • •3. Female subjects of childbearing potential must have a negative urine pregnancy test at the baseline visit (Visit 1);
  • •4. Agrees to use a medically acceptable method of contraception throughout the study and for 6 weeks after completing the study.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 150
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

  • •1. Intends to use any doses of Rytary or Duopa during this study;
  • •2. Plans to use an investigational treatment other than IPX203 during the course of this study;
  • •3. Neurosurgical ablation treatment for PD is planned or anticipated during the study period. Implantation of a deep brain stimulator (DBS) for the treatment of PD is permitted during this study;
  • •4. Subjects who, in the opinion of the clinical investigator, should not participate in the study.

Investigators

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