NE3107 Activity and Safety in Patients With Parkinson’s Disease Using Levodopa – Full Text View

  • Change from baseline (day 1) in Motor disease society- Unified Parkinson’s disease rating scale Part III total score for the patient in the “off-state” (without L-dopa for previous eight hours) [ Time Frame: measured on day 1, 2, 3, 14, and 28 ]

    Unified Parkinson’s disease rating scale Part III total score is the cumulative score of a 33 question assessment of disease impact on patient’s ability to move, with each part scored on a scale of 0-4, with 0 being no effect of disease and 4 being severe disease. a total score of 0 indicates no disease and a total score of 132 indicates the most severe disease

  • Change from baseline in the length of time during which L-dopa therapy is ineffective in reducing motor symptoms of disease (OFF time) [ Time Frame: off time will be measured/recorded every day from day 2 to day 27 ]

    The total sum of time in which a patient self categorizes themselves as in the “off” state determined by diary entries. 0 hours is the minimum/best score, which indicates continuous L-dopa-like activity for the 24 hour period. 24 hours is the worst score and indicates that there was no L-dopa-like benefit at any time during the 24 hour period.

  • Change from baseline in average Motor disease society- Unified Parkinson’s disease rating scale Part III total score measured over the course of 8 hours after taking L-dopa and/or NE3107 [ Time Frame: measured on day 1, 2, 3, 14, and 28 ]

    An average score will be calculated from assessments of the Unified Parkinson’s disease rating scale Part III total score, which is the cumulative score of a 33 question assessment of disease impact on patient’s ability to move, with each question scored on a scale of 0-4, with 0 being no effect of disease and 4 being severe disease. a total score of 0 indicates no disease and a total score of 132 indicates the most severe disease. Scores will be collected several times during the eight hours following L-dopa and/or NE3107 administration.

  • Motor disease society- Unified Parkinson’s disease rating scale Part I total score [ Time Frame: measured on day 1, 2, 3, 14, and 28 ]

    the cumulative score of a 13 question assessment of disease impact on patient’s cognitive impairment, with each question scored on a scale of 0-4, with 0 being no effect of disease and 4 being severe disease. a total score of 0 indicates no disease and a total score of 42 indicates the most severe disease. This test asks about the impact of disease on cognition, but does not directly measure cognitive capability.

  • Motor disease society- Unified Parkinson’s disease rating scale Part 2 total score [ Time Frame: measured on day 1, 2, 3, 14, and 28 ]

    the cumulative score of a 13 question assessment of disease impact on patient’s Motor Aspects of Experiences of Daily Living, with each question scored on a scale of 0-4, with 0 being no effect of disease and 4 being a severe effect. a total score of 0 indicates no disease and a total score of 42 indicates the most severe disease.

  • Change from baseline in the length of time during which L-dopa-like effects are felt by the patient [ Time Frame: baseline and day 1, 2, 3, 14, and 28 ]

    The total sum of time in which a patient self categorizes themselves as in the “on” state, with or without dyskinesia determined by diary entries. 0 hours is the minimum/worst score, which indicates no L-dopa-like activity for the 24 hour period. 24 hours is the best score and indicates that there was no L-dopa-like benefit at any time during the 24 hour period.

  • change from baseline in L-dopa induced dyskinesia measured with the abnormal involuntary movement scale (AIMS) [ Time Frame: AIMS will be measured during the 8 hour period of observation on Day 1, 2, 3, 14, and 28 ]

    AIMS is a 12-item clinician-rated scale to assess severity of dyskinesias (orofacial movements and extremity and truncal movements) in patients taking L-dopa. Questions assess the overall severity, incapacitation, and the patient’s level of awareness of the movements, and distress associated with them. Questions are scored from 0 (no symptom) to 4 (severe). the minimum total score of 0 indicates no dyskinesia and the maximum total score of 48 indicates severe dyskinesia.

  • change from baseline in time to onset of L-dopa-like activity [ Time Frame: measured on Day 1, 2, 3, 14, and 28 ]

    Length of time from L-dopa administration to beginning of L-dopa activity producing “on-state”. Patient self assessment of the time L-dopa-like activity begins after L-dopa administration. A decrease in the time to onset may shorten the time in the off-state and be considered a patient benefit. An increase in time to onset may lengthen time in the off-state and be considered a general worsening of response to treatment.

  • Change from baseline in Non-Motor Symptom Assessment Scale for Parkinson Disease (NMSS) [ Time Frame: Measured on Day 1, 2, 3, 14, and 28 ]

    The Non-Motor Symptoms Scale (NMSS) is a 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson’s disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. The scale can be used for patients at all stages of PD. For each question, scores of severity (0 to 3, with 0 being none and 3 being major source of distress) and frequency (1 to 4, 1= rarely and 4 = very frequent) are recorded and the product of the two calculated. The sum of the products yields the overall score. The minimum total score of 0 indicates no non-motor symptoms and the maximum score of 360 indicates severe disease.

  • change in area under the levodopa plasma concentration vs. time curve when administered alone compared to being co-administered with NE3107 [ Time Frame: Blood samples will be collected on Day 1, 2, 3, and 14 ]

    the plasma concentration vs time curve for L-dopa will be calculated from the L-dopa concentration in plasma samples collected prior to dosing and at 0.5, 1, 2, 3, 4, and 8 hours after L-dopa administration on days on which NE3107 is not administered (Day 1) and three days on which NE3107 is co-administered (Day 2, 3, and 14). Changes in L-dopa area under the curve could be associated with changes in activity against motor symptoms of disease.

  • Change in the maximum plasma concentration (Cmax) of levodopa when administered alone compared to being co-administered with NE3107. [ Time Frame: Blood samples will be collected on Day 1, 2, 3, and 14 ]

    the maximum plasma concentration for L-dopa will be determined in plasma samples collected prior to dosing and at 0.5, 1, 2, 3, 4, and 8 hours after L-dopa administration on days on which NE3107 is not administered (Day 1) and three days on which NE3107 is co-administered (Day 2, 3, and 14). Changes in L-dopa Cmax could be associated with changes in activity against motor symptoms of disease.

  • The area under the NE3107 plasma concentration vs. time curve when administered alone compared to being co-administered with [ Time Frame: Blood samples will be collected on Day 2, 3, and 14 ]

    the plasma concentration vs time curve for NE3107 will be calculated from the NE3107 concentration in plasma samples collected prior to dosing and at 0.5, 1, 2, 3, 4, and 8 hours

  • Change in the maximum plasma concentration (Cmax) of NE3107 when administered alone compared to being co-administered with L-dopa [ Time Frame: Blood samples will be collected on Day 2, 3, and 14 ]

    the maximum plasma concentration for NE3107 will be determined in plasma samples collected prior to dosing and at 0.5, 1, 2, 3, 4, and 8 hours after NE3107 administration

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