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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: IPX203 140 mg Drug: IPX203 210 mg Drug: IPX203 280 mg Drug: IPX203 350 mg Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor Fluctuations
Actual Study Start Date : April 3, 2019
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Baseline through end of study up to 9 months ]
    Summary by system organ class and preferred terms of AEs


Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.


  6. 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.


  7. 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.


  8. 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.


  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.


  22. 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.


  23. 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.


  24. 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.


  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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)

  37. 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)

  38. 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. 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)

  40. 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


  41. 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


  42. 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


  43. 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


  44. 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.

  45. 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.

  46. 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.

  47. 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.

  48. 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.

  49. 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.

  50. 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.

  51. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877510


Locations
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Sponsors and Collaborators
Impax Laboratories, LLC
Investigators
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Study Director: Impax Impax Study Director Impax Laboratories, LLC
More Information
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Responsible Party: Impax Laboratories, LLC
ClinicalTrials.gov Identifier: NCT03877510    
Other Study ID Numbers: IPX203-B16-03
2018-002234-21 ( EudraCT Number )
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Impax Laboratories, LLC:
motor fluctuations
IPX203
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases