Trial Outcomes & Findings for Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations (NCT NCT01515410)
NCT ID: NCT01515410
Last Updated: 2014-03-10
Results Overview
"OFF" indicates wearing off motor fluctuations before the next levodopa dose. Percent "OFF" time is calculated as the total "OFF" time divided by the total awake time for each day and multiplied by 100. Patient diary-every 30min while awake for 3days prior to initial Day1 as baseline \& during the last 3days before Day10 for both treatments for dyskinesia state. Baseline is the average of the 3 days recorded in the patient diary prior to Day 1 of Period 1. End of Period is the average of the 3 days recorded in the patient diary prior to Day 10 in each period. Clinician-Assess efficacy at pre-dose, every 30min for Day1 and hourly for Day10 for dyskinesia state \& motor fluctuations at clinic visits.
COMPLETED
PHASE2
34 participants
Baseline and 10 days for each of the 2 study periods
2014-03-10
Participant Flow
A total of 34 subjects were randomly assigned to treatment in this crossover study: 19 in the DM-1992 for Period 1 and Sinemet IR for Period 2 sequence, and 15 in the Sinemet IR for Period 1 and DM-1992 for Period 2 sequence. All 34 subjects received study treatment and were included in the safety and intent-to-treat (ITT) populations.
Participant milestones
| Measure |
DM-1992 First, Then Sinemet IR
DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD) first, then Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
|
Sinemet IR First, Then DM-1992
Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD) first, then DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
15
|
|
Overall Study
COMPLETED
|
19
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations
Baseline characteristics by cohort
| Measure |
Overall Study
n=34 Participants
DM-1992 first, then Sinemet IR; Sinemet IR first, then DM-1992
|
|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 8.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
32 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Afro-Caribbean
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
|
Percent "OFF" Time (%)
|
32.50 percentage of time
STANDARD_DEVIATION 9.962 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 10 days for each of the 2 study periodsPopulation: Modified Intent-to-treat (ITT) Population
"OFF" indicates wearing off motor fluctuations before the next levodopa dose. Percent "OFF" time is calculated as the total "OFF" time divided by the total awake time for each day and multiplied by 100. Patient diary-every 30min while awake for 3days prior to initial Day1 as baseline \& during the last 3days before Day10 for both treatments for dyskinesia state. Baseline is the average of the 3 days recorded in the patient diary prior to Day 1 of Period 1. End of Period is the average of the 3 days recorded in the patient diary prior to Day 10 in each period. Clinician-Assess efficacy at pre-dose, every 30min for Day1 and hourly for Day10 for dyskinesia state \& motor fluctuations at clinic visits.
Outcome measures
| Measure |
DM-1992
n=34 Participants
DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
|
Sinemet IR
n=34 Participants
Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
|
|---|---|---|
|
The Primary Objective of This Study is to Explore the Efficacy and Tolerability of DM-1992 Compared to a Standard CD/LD IR Formulation as Measured by Percent "OFF" Time.
|
-5.52 percentage of time
Interval -10.42 to -0.63
|
1.33 percentage of time
Interval -3.56 to 6.22
|
Adverse Events
DM-1992
Sinemet IR
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DM-1992
n=34 participants at risk
DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
|
Sinemet IR
n=34 participants at risk
Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
5.9%
2/34 • Number of events 2 • Adverse events collected for a total of 5-6 weeks: from after signing the informed consent to the end of the study (Period 2, Day 10).
Adverse event collection began after signing the informed consent and continued through Period 2, Day 10; serious adverse events followed for 30 days after study completion.
|
0.00%
0/34 • Adverse events collected for a total of 5-6 weeks: from after signing the informed consent to the end of the study (Period 2, Day 10).
Adverse event collection began after signing the informed consent and continued through Period 2, Day 10; serious adverse events followed for 30 days after study completion.
|
|
Nervous system disorders
Parkinsonian gait
|
8.8%
3/34 • Number of events 3 • Adverse events collected for a total of 5-6 weeks: from after signing the informed consent to the end of the study (Period 2, Day 10).
Adverse event collection began after signing the informed consent and continued through Period 2, Day 10; serious adverse events followed for 30 days after study completion.
|
5.9%
2/34 • Number of events 2 • Adverse events collected for a total of 5-6 weeks: from after signing the informed consent to the end of the study (Period 2, Day 10).
Adverse event collection began after signing the informed consent and continued through Period 2, Day 10; serious adverse events followed for 30 days after study completion.
|
|
Nervous system disorders
Dizziness
|
8.8%
3/34 • Number of events 3 • Adverse events collected for a total of 5-6 weeks: from after signing the informed consent to the end of the study (Period 2, Day 10).
Adverse event collection began after signing the informed consent and continued through Period 2, Day 10; serious adverse events followed for 30 days after study completion.
|
0.00%
0/34 • Adverse events collected for a total of 5-6 weeks: from after signing the informed consent to the end of the study (Period 2, Day 10).
Adverse event collection began after signing the informed consent and continued through Period 2, Day 10; serious adverse events followed for 30 days after study completion.
|
|
Nervous system disorders
Hypertonia
|
5.9%
2/34 • Number of events 2 • Adverse events collected for a total of 5-6 weeks: from after signing the informed consent to the end of the study (Period 2, Day 10).
Adverse event collection began after signing the informed consent and continued through Period 2, Day 10; serious adverse events followed for 30 days after study completion.
|
5.9%
2/34 • Number of events 2 • Adverse events collected for a total of 5-6 weeks: from after signing the informed consent to the end of the study (Period 2, Day 10).
Adverse event collection began after signing the informed consent and continued through Period 2, Day 10; serious adverse events followed for 30 days after study completion.
|
|
Nervous system disorders
Headache
|
5.9%
2/34 • Number of events 2 • Adverse events collected for a total of 5-6 weeks: from after signing the informed consent to the end of the study (Period 2, Day 10).
Adverse event collection began after signing the informed consent and continued through Period 2, Day 10; serious adverse events followed for 30 days after study completion.
|
0.00%
0/34 • Adverse events collected for a total of 5-6 weeks: from after signing the informed consent to the end of the study (Period 2, Day 10).
Adverse event collection began after signing the informed consent and continued through Period 2, Day 10; serious adverse events followed for 30 days after study completion.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI agrees that sponsor shall have the right to the first publication of the study results which is intended to be a joint, multi-center publication. Following the first publication, the PI may publish study data or results, provided however PI submits the proposed publication to sponsor for review at least 60 days prior to the date of the proposed publication. Sponsor may remove any information that is considered confidential and/or proprietary other than study data.
- Publication restrictions are in place
Restriction type: OTHER