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

By cbdweb On Oct 21, 2021

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