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Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in PD Patients With Motor Fluctuations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03877510
Recruitment Status : Enrolling by invitation
First Posted : March 15, 2019
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
Impax Laboratories, LLC

Tracking Information
First Submitted Date  ICMJE March 12, 2019
First Posted Date  ICMJE March 15, 2019
Last Update Posted Date January 6, 2021
Actual Study Start Date  ICMJE April 3, 2019
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
Adverse Events [ Time Frame: Baseline through end of study up to 9 months ]
Summary by system organ class and preferred terms of AEs
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Total [ Time Frame: Baseline ]
    Measure of the MDS-UPDRS - sum total of 4 parts. Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL) has 2 components. Component IA contains a number of behaviors assessed by the investigator. Component IB is completed by the patient. Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52. Part II: Motor Aspects of Experiences of Daily Living (M-EDL) self-administered questionnaire. 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52. Part III: Motor Examination assesses the motor signs of PD; completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132 Part IV: Motor Complications; completed by the rater. 6 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 24. Overall sum ranges from 0-260.
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Total [ Time Frame: Month 3 ]
    Measure of the MDS-UPDRS - sum total of 4 parts. Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL) has 2 components. Component IA contains a number of behaviors assessed by the investigator. Component IB is completed by the patient. Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52. Part II: Motor Aspects of Experiences of Daily Living (M-EDL) self-administered questionnaire. 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52. Part III: Motor Examination assesses the motor signs of PD; completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132 Part IV: Motor Complications; completed by the rater. 6 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 24. Overall sum ranges from 0-260.
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Total [ Time Frame: Month 6 ]
    Measure of the MDS-UPDRS - sum total of 4 parts. Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL) has 2 components. Component IA contains a number of behaviors assessed by the investigator. Component IB is completed by the patient. Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52. Part II: Motor Aspects of Experiences of Daily Living (M-EDL) self-administered questionnaire. 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52. Part III: Motor Examination assesses the motor signs of PD; completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132 Part IV: Motor Complications; completed by the rater. 6 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 24. Overall sum ranges from 0-260.
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Total [ Time Frame: Month 9 ]
    Measure of the MDS-UPDRS - sum total of 4 parts. Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL) has 2 components. Component IA contains a number of behaviors assessed by the investigator. Component IB is completed by the patient. Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52. Part II: Motor Aspects of Experiences of Daily Living (M-EDL) self-administered questionnaire. 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52. Part III: Motor Examination assesses the motor signs of PD; completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132 Part IV: Motor Complications; completed by the rater. 6 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 24. Overall sum ranges from 0-260.
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 1 [ Time Frame: Baseline ]
    Measure of the MDS-UPDRS - Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL) has 2 components. Component IA contains a number of behaviors assessed by the investigator with all pertinent information from the patients and caregivers. Component IB is completed by the patient with or without help from the caregiver but independent of the investigator. Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 1 [ Time Frame: Month 3 ]
    Measure of the MDS-UPDRS - Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL) has 2 components. Component IA contains a number of behaviors assessed by the investigator with all pertinent information from the patients and caregivers. Component IB is completed by the patient with or without help from the caregiver but independent of the investigator. Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part1 [ Time Frame: Month 6 ]
    Measure of the MDS-UPDRS - Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL) has 2 components. Component IA contains a number of behaviors assessed by the investigator with all pertinent information from the patients and caregivers. Component IB is completed by the patient with or without help from the caregiver but independent of the investigator. Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 1 [ Time Frame: Month 9 ]
    Measure of the MDS-UPDRS - Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL) has 2 components. Component IA contains a number of behaviors assessed by the investigator with all pertinent information from the patients and caregivers. Component IB is completed by the patient with or without help from the caregiver but independent of the investigator. Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 2 [ Time Frame: Baseline ]
    Measure of the MDS-UPDRS - Part II: Motor Aspects of Experiences of Daily Living (M-EDL) is a self-administered questionnaire Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 2 [ Time Frame: Month 3 ]
    Measure of the MDS-UPDRS - Part II: Motor Aspects of Experiences of Daily Living (M-EDL) is a self-administered questionnaire Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 2 [ Time Frame: Month 6 ]
    Measure of the MDS-UPDRS - Part II: Motor Aspects of Experiences of Daily Living (M-EDL) is a self-administered questionnaire Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 2 [ Time Frame: Month 9 ]
    Measure of the MDS-UPDRS - Part II: Motor Aspects of Experiences of Daily Living (M-EDL) is a self-administered questionnaire Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 3 [ Time Frame: Baseline ]
    Measure of the MDS-UPDRS - Part III: Motor Examination assesses the motor signs of PD; it is completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 3 [ Time Frame: Month 3 ]
    Measure of the MDS-UPDRS - Part III: Motor Examination assesses the motor signs of PD; it is completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 3 [ Time Frame: Month 6 ]
    Measure of the MDS-UPDRS - Part III: Motor Examination assesses the motor signs of PD; it is completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 3 [ Time Frame: Month 9 ]
    Measure of the MDS-UPDRS - Part III: Motor Examination assesses the motor signs of PD; it is completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 4 [ Time Frame: Baseline ]
    Part IV: Motor Complications; completed by the rater. 6 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 24.
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 4 [ Time Frame: Month 3 ]
    Part IV: Motor Complications; completed by the rater. 6 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 24.
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 4 [ Time Frame: Month 6 ]
    Part IV: Motor Complications; completed by the rater. 6 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 24.
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 4 [ Time Frame: Month 9 ]
    Part IV: Motor Complications; completed by the rater. 6 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 24.
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Sum of Parts II and III [ Time Frame: Baseline ]
    Sum of MDS-UPDRS Parts II and III. Part II: Motor Aspects of Experiences of Daily Living (M-EDL) self-administered questionnaire. 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52. Part III: Motor Examination assesses the motor signs of PD; completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132 Total score ranges from 0 to 184.
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) of Parts II and III [ Time Frame: Month 3 ]
    Sum of MDS-UPDRS Parts II and III. Part II: Motor Aspects of Experiences of Daily Living (M-EDL) self-administered questionnaire. 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52. Part III: Motor Examination assesses the motor signs of PD; completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132 Total score ranges from 0 to 184.
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Sum of Parts II and III [ Time Frame: Month 6 ]
    Sum of MDS-UPDRS Parts II and III. Part II: Motor Aspects of Experiences of Daily Living (M-EDL) self-administered questionnaire. 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52. Part III: Motor Examination assesses the motor signs of PD; completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132 Total score ranges from 0 to 184.
  • Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Sum of Parts II and III [ Time Frame: Month 9 ]
    Sum of MDS-UPDRS Parts II and III. Part II: Motor Aspects of Experiences of Daily Living (M-EDL) self-administered questionnaire. 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52. Part III: Motor Examination assesses the motor signs of PD; completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132 Total score ranges from 0 to 184.
  • Treatment Satisfaction Assessment (TSA) [ Time Frame: Month 3 ]
    The TSA is a subject answered assessment rating treatment satisfaction on a scale of 1 to 7; 1 being least satisfied and 7 being most satisfied.
  • Treatment Satisfaction Assessment (TSA) [ Time Frame: Month 6 ]
    The TSA is a subject answered assessment rating treatment satisfaction on a scale of 1 to 7; 1 being least satisfied and 7 being most satisfied.
  • Treatment Satisfaction Assessment (TSA) [ Time Frame: Month 9 ]
    The TSA is a subject answered assessment rating treatment satisfaction on a scale of 1 to 7; 1 being least satisfied and 7 being most satisfied.
  • Patient Global Impression of Severity (PGI-S) [ Time Frame: Baseline ]
    The PGI-S is a subject answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1 being normal not at all ill and 7 extremely severely ill.
  • Patient Global Impression of Severity (PGI-S) [ Time Frame: Month 3 ]
    The PGI-S is a subject answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1 being normal not at all ill and 7 extremely severely ill.
  • Patient Global Impression of Severity (PGI-S) [ Time Frame: Month 6 ]
    The PGI-S is a subject answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1 being normal not at all ill and 7 extremely severely ill.
  • Patient Global Impression of Severity (PGI-S) [ Time Frame: Month 9 ]
    The PGI-S is a subject answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1 being normal not at all ill and 7 extremely severely ill.
  • Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline ]
    The CGI-S is a clinician scale rating the severity of the subject's illness on a scale of 1 to 7 with 1 being Normal, not at all ill and 7 being among the most extremely ill of subjects.
  • Clinical Global Impression of Severity (CGI-S) [ Time Frame: Month 3 ]
    The CGI-S is a clinician scale rating the severity of the subject's illness on a scale of 1 to 7 with 1 being Normal, not at all ill and 7 being among the most extremely ill of subjects.
  • Clinical Global Impression of Severity (CGI-S) [ Time Frame: Month 6 ]
    The CGI-S is a clinician scale rating the severity of the subject's illness on a scale of 1 to 7 with 1 being Normal, not at all ill and 7 being among the most extremely ill of subjects.
  • Clinical Global Impression of Severity (CGI-S) [ Time Frame: Month 9 ]
    The CGI-S is a clinician scale rating the severity of the subject's illness on a scale of 1 to 7 with 1 being Normal, not at all ill and 7 being among the most extremely ill of subjects.
  • 39-item Parkinson's disease questionnaire (PDQ-39) [ Time Frame: Baseline ]
    The PDQ-39 is a self-reported 39 question Parkinson's disease Quality of Life Questionnaire with 5 choices ranging from "never" (least amount of difficulty) to Always (or cannot do at all; most difficult)
  • 39-item Parkinson's disease questionnaire (PDQ-39) [ Time Frame: Month 3 ]
    The PDQ-39 is a self-reported 39 question Parkinson's disease Quality of Life Questionnaire with 5 choices ranging from "never" (least amount of difficulty) to Always (or cannot do at all; most difficult)
  • 39-item Parkinson's disease questionnaire (PDQ-39) [ Time Frame: Month 6 ]
    The PDQ-39 is a self-reported 39 question Parkinson's disease Quality of Life Questionnaire with 5 choices ranging from "never" (least amount of difficulty) to Always (or cannot do at all; most difficult)
  • 39-item Parkinson's disease questionnaire (PDQ-39) [ Time Frame: Month 9 ]
    The PDQ-39 is a self-reported 39 question Parkinson's disease Quality of Life Questionnaire with 5 choices ranging from "never" (least amount of difficulty) to Always (or cannot do at all; most difficult)
  • Parkinson Anxiety Scale (PAS) [ Time Frame: Baseline ]
    The PAS is a three part subject answered assessment. Totals for all three parts are summed. Part 1 has 5 questions measuring persistent anxiety. Each question ranges from 0 - not at all, or never to 4 severe, or nearly always. Best score is 0; worst score is 20. Part 2 has 4 questions measuring episodic anxiety. Each question ranges from 0 - never to 4 - nearly always. Best score is 0; worst score is 16. Part 3 has 3 questions measuring avoidance behavior. Each question ranges from 0, never to 4 nearly always. Best score is 0; worst score is 12. Possible overall best score: 0 Possible overall worst score: 48
  • Parkinson Anxiety Scale (PAS) [ Time Frame: Month 3 ]
    The PAS is a three part subject answered assessment. Totals for all three parts are summed. Part 1 has 5 questions measuring persistent anxiety. Each question ranges from 0 - not at all, or never to 4 severe, or nearly always. Best score is 0; worst score is 20. Part 2 has 4 questions measuring episodic anxiety. Each question ranges from 0 - never to 4 - nearly always. Best score is 0; worst score is 16. Part 3 has 3 questions measuring avoidance behavior. Each question ranges from 0, never to 4 nearly always. Best score is 0; worst score is 12. Possible overall best score: 0 Possible overall worst score: 48
  • Parkinson Anxiety Scale (PAS) [ Time Frame: Month 6 ]
    The PAS is a three part subject answered assessment. Totals for all three parts are summed. Part 1 has 5 questions measuring persistent anxiety. Each question ranges from 0 - not at all, or never to 4 severe, or nearly always. Best score is 0; worst score is 20. Part 2 has 4 questions measuring episodic anxiety. Each question ranges from 0 - never to 4 - nearly always. Best score is 0; worst score is 16. Part 3 has 3 questions measuring avoidance behavior. Each question ranges from 0, never to 4 nearly always. Best score is 0; worst score is 12. Possible overall best score: 0 Possible overall worst score: 48
  • Parkinson Anxiety Scale (PAS) [ Time Frame: Month 9 ]
    The PAS is a three part subject answered assessment. Totals for all three parts are summed. Part 1 has 5 questions measuring persistent anxiety. Each question ranges from 0 - not at all, or never to 4 severe, or nearly always. Best score is 0; worst score is 20. Part 2 has 4 questions measuring episodic anxiety. Each question ranges from 0 - never to 4 - nearly always. Best score is 0; worst score is 16. Part 3 has 3 questions measuring avoidance behavior. Each question ranges from 0, never to 4 nearly always. Best score is 0; worst score is 12. Possible overall best score: 0 Possible overall worst score: 48
  • Non-motor symptom assessment scale for PD (NMSS) [ Time Frame: Baseline ]
    The NMSS is a 9 domain, 30 question scale rating symptom severity on a scale of 0-3 with 3 being most severe; and frequency on a scale of 1-4 with 4 being most frequent. Each question is answered with a severity and frequency rating which are then multiplied. The sum of the products gives the total score. Zero is the best score and 360 is the worst score.
  • Non-motor symptom assessment scale for PD (NMSS) [ Time Frame: Month 3 ]
    The NMSS is a 9 domain, 30 question scale rating symptom severity on a scale of 0-3 with 3 being most severe; and frequency on a scale of 1-4 with 4 being most frequent. Each question is answered with a severity and frequency rating which are then multiplied. The sum of the products gives the total score. Zero is the best score and 360 is the worst score.
  • Non-motor symptom assessment scale for PD (NMSS) [ Time Frame: Month 6 ]
    The NMSS is a 9 domain, 30 question scale rating symptom severity on a scale of 0-3 with 3 being most severe; and frequency on a scale of 1-4 with 4 being most frequent. Each question is answered with a severity and frequency rating which are then multiplied. The sum of the products gives the total score. Zero is the best score and 360 is the worst score.
  • Non-motor symptom assessment scale for PD (NMSS) [ Time Frame: Month 9 ]
    The NMSS is a 9 domain, 30 question scale rating symptom severity on a scale of 0-3 with 3 being most severe; and frequency on a scale of 1-4 with 4 being most frequent. Each question is answered with a severity and frequency rating which are then multiplied. The sum of the products gives the total score. Zero is the best score and 360 is the worst score.
  • Parkinson's Disease Sleep Scale - 2 (PDSS-2) [ Time Frame: Baseline ]
    The PDSS-2 is a 15 question subject response scale measuring the severity of sleep disturbance. Each question is rate as very often to never on a scale of 0-4. The best overall score is 0; the worst overall score is 60.
  • Parkinson's Disease Sleep Scale - 2 (PDSS-2) [ Time Frame: Month 3 ]
    The PDSS-2 is a 15 question subject response scale measuring the severity of sleep disturbance. Each question is rate as very often to never on a scale of 0-4. The best overall score is 0; the worst overall score is 60.
  • Parkinson's Disease Sleep Scale - 2 (PDSS-2) [ Time Frame: Month 6 ]
    The PDSS-2 is a 15 question subject response scale measuring the severity of sleep disturbance. Each question is rate as very often to never on a scale of 0-4. The best overall score is 0; the worst overall score is 60.
  • Parkinson's Disease Sleep Scale - 2 (PDSS-2) [ Time Frame: Month 9 ]
    The PDSS-2 is a 15 question subject response scale measuring the severity of sleep disturbance. Each question is rate as very often to never on a scale of 0-4. The best overall score is 0; the worst overall score is 60.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in PD Patients With Motor Fluctuations
Official Title  ICMJE An Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor Fluctuations
Brief Summary The purpose of this study is to evaluate the long-term safety and clinical utility of IPX203 in the treatment of subjects with advanced Parkinson's disease (PD) who have motor fluctuations.
Detailed Description This is a 9-month, multicenter open-label safety extension study. Subjects who have successfully completed Study IPX203-B16-02 [A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 with Immediate-Release (IR) Carbidopa-Levodopa (CD-LD) in Parkinson's Disease Patients with Motor Fluctuations] may have the opportunity to enroll in this open-label study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Drug: IPX203 140 mg
    35 mg - 140 mg CD-LD extended release capsules
    Other Name: IPX203 35-140 mg
  • Drug: IPX203 210 mg
    52.5 mg - 210 mg CD-LD extended release capsules
    Other Name: IPX203 52.5-210 mg
  • Drug: IPX203 280 mg
    70 mg - 280 mg CD-LD extended release capsules
    Other Name: IPX203 70-280mg
  • Drug: IPX203 350 mg
    87.5 mg - 350 mg CD-LD extended release capsules
    Other Name: IPX203 87.5-350mg
Study Arms  ICMJE Experimental: Open Label IPX203
Subjects will receive IPX203 140 mg, IPX203 210 mg, IPX203 280 mg, or IPX203 350 mg for approximately 9 months. The dose and dosing frequency will be determined by the investigator.
Interventions:
  • Drug: IPX203 140 mg
  • Drug: IPX203 210 mg
  • Drug: IPX203 280 mg
  • Drug: IPX203 350 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: March 14, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2022
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Successfully completed Study IPX203-B16-02
  • Able to provide written informed consent prior to the conduct of any study-specific procedures.
  • Female subjects 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.
  • Subjects who, in the opinion of the clinical investigator, should not participate in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   France,   Germany,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03877510
Other Study ID Numbers  ICMJE IPX203-B16-03
2018-002234-21 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Impax Laboratories, LLC
Study Sponsor  ICMJE Impax Laboratories, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Impax Impax Study Director Impax Laboratories, LLC
PRS Account Impax Laboratories, LLC
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP