Phase 3
Completed N=419
Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations
Source: ClinicalTrials.gov NCT03877510 ↗Enrolled (actual)
419
Serious AEs
10.0%
Results posted
Jun 2023
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events — 221 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to evaluate the long-term safety and clinical utility of IPX203 in the treatment of participants with advanced Parkinson's disease (PD) who have motor fluctuations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events |
221 | — |
| SECONDARY Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total |
56.7; 56.5; 56.0; 59.0 | — |
| SECONDARY Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total |
2.7 | — |
| SECONDARY Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I |
9.9; 10.6; 10.7; 11.0 | — |
| SECONDARY Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I |
1.2 | — |
| SECONDARY Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II |
12.8; 13.0; 12.8; 13.6 | — |
| SECONDARY Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II |
0.9 | — |
| SECONDARY Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III |
27.5; 26.8; 26.6; 27.8 | — |
| SECONDARY Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III |
0.6 | — |
| SECONDARY Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV |
6.6; 6.0; 6.0; 6.6 | — |
| SECONDARY Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV |
0.0 | — |
| SECONDARY Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III |
40.3; 39.8; 39.4; 41.5 | — |
| SECONDARY Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III |
1.5 | — |
| SECONDARY Patient Global Impression of Severity (PGI-S) |
3.7; 3.8; 3.7; 3.8 | — |
| SECONDARY Change From Baseline in Patient Global Impression of Severity (PGI-S) |
0.0 | — |
| SECONDARY Percentage of Participants With a PGI-S ≥ 4 and PGI-S ≥ 5 |
64.5; 20.3; 66.7; 20.0; 62.5; 20.7 | — |
| SECONDARY Clinical Global Impression of Severity (CGI-S) |
3.8; 3.8; 3.7; 3.8 | — |
| SECONDARY Change From Baseline in Clinical Global Impression of Severity (CGI-S) |
0.0 | — |
| SECONDARY Percentage of Participants With a CGI-S ≥ 4 and CGI-S ≥ 5 |
66.7; 19.6; 64.8; 18.3; 61.2; 14.0 | — |
| SECONDARY 39-item Parkinson's Disease Questionnaire (PDQ-39): Total |
41.7; 42.7; 42.8; 45.1 | — |
| SECONDARY Change From Baseline in PDQ-39: Total |
4.4 | — |
| SECONDARY Parkinson Anxiety Scale (PAS): Total |
10.4; 10.3; 10.3; 11.1 | — |
| SECONDARY Change From Baseline in Parkinson Anxiety Scale (PAS): Total |
0.9 | — |
| SECONDARY Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total |
32.0; 32.5; 33.4; 35.3 | — |
| SECONDARY Change From Baseline in Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total |
3.8 | — |
| SECONDARY Parkinson's Disease Sleep Scale-2 (PDSS-2) Total |
16.6; 15.8; 16.1; 16.2 | — |
| SECONDARY Change From Baseline in Parkinson's Disease Sleep Scale-2 (PDSS-2):Total |
-0.1 | — |
| SECONDARY Treatment Satisfaction Assessment (TSA) |
5.2; 5.4; 5.2 | — |
| SECONDARY Percentage of Participants With TSA Scores 5-7 (Satisfied) Versus Scores 1-4 (Dissatisfied or Neutral) |
19.6; 80.4; 15.6; 84.4; 23.7; 76.3 | — |
Eligibility Criteria
Inclusion Criteria
- Successfully completed Study IPX203-B16-02
- Able to provide written informed consent prior to the conduct of any study-specific procedures.
- Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit (Visit 1).
- Agrees to use a medically acceptable method of contraception throughout the study and for 6 weeks after completing the study.
Exclusion Criteria
- Intends to use any doses of Rytary® or Duopa™ during this study.
- Plans to use an investigational treatment other than IPX203 during the course of this study.
- 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.
- Participants who, in the opinion of the clinical investigator, should not participate in the study.
Data sourced from ClinicalTrials.gov (NCT03877510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.