Trial Outcomes & Findings for Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET) (NCT NCT03781791)
NCT ID: NCT03781791
Last Updated: 2024-02-20
Results Overview
The number of treatment related adverse events as reported and assessed by NCI CTCAE v.4.3.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
151 participants
Primary outcome timeframe
Through Study treatment up to 10 weeks
Results posted on
2024-02-20
Participant Flow
Participant milestones
| Measure |
Active Treatment
ENT-01 tablet will be taken once daily by mouth.
Active Investigational Treatment ENT-01: ENT-01 will be administered in tablet form, once daily.
|
Placebo Treatment
Placebo tablet will be taken once daily by mouth.
Placebo Treatment: Placebo will be administered in tablet form, once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
57
|
|
Overall Study
COMPLETED
|
67
|
50
|
|
Overall Study
NOT COMPLETED
|
26
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET)
Baseline characteristics by cohort
| Measure |
Active Treatment
n=93 Participants
ENT-01 tablet will be taken once daily by mouth.
Active Investigational Treatment ENT-01: ENT-01 will be administered in tablet form, once daily.
|
Placebo Treatment
n=57 Participants
Placebo tablet will be taken once daily by mouth.
Placebo Treatment: Placebo will be administered in tablet form, once daily.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.0 years
STANDARD_DEVIATION 8.75 • n=5 Participants
|
71.0 years
STANDARD_DEVIATION 6.66 • n=7 Participants
|
69.0 years
STANDARD_DEVIATION 8.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
93 participants
n=5 Participants
|
58 participants
n=7 Participants
|
151 participants
n=5 Participants
|
|
Years of Constipation
|
10.2 years
STANDARD_DEVIATION 10.94 • n=5 Participants
|
16.4 years
STANDARD_DEVIATION 19.73 • n=7 Participants
|
12.6 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Through Study treatment up to 10 weeksThe number of treatment related adverse events as reported and assessed by NCI CTCAE v.4.3.
Outcome measures
| Measure |
Active Treatment
n=93 Participants
ENT-01 tablet will be taken once daily by mouth.
Active Investigational Treatment ENT-01: ENT-01 will be administered in tablet form, once daily.
|
Placebo Treatment
n=57 Participants
Placebo tablet will be taken once daily by mouth.
Placebo Treatment: Placebo will be administered in tablet form, once daily.
|
|---|---|---|
|
The Number of Participants Who Experience Treatment Related Adverse Events-Safety Endpoint
|
44 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Through Study treatment Dosing Period up to 10 weeksThe number of participants who experience dose limiting toxicity adverse events as reported and assessed by NCI CTCAE v.4.3. Per protocol, dose limiting toxicity adverse events are vomiting, diarrhea, abdominal pain and dizziness.
Outcome measures
| Measure |
Active Treatment
n=93 Participants
ENT-01 tablet will be taken once daily by mouth.
Active Investigational Treatment ENT-01: ENT-01 will be administered in tablet form, once daily.
|
Placebo Treatment
n=57 Participants
Placebo tablet will be taken once daily by mouth.
Placebo Treatment: Placebo will be administered in tablet form, once daily.
|
|---|---|---|
|
The Number of Participants Who Experience Dose Limiting Toxicity Adverse Events
|
38 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 25 day treatment period, part of which is at a fixed dose.Change from participant's weekly CSBM baseline rate during treatment fixed Dose period. The fixed dose period begins on the first day or the subject's highest dose at which the subject did not experience a dose limiting toxicity (nausea, vomiting, diarrhea or dizziness) The fixed dose period will not be a specific time period for all subjects since each subject will start the fixed dose period based on their tolerability to ENT-01 dosing.
Outcome measures
| Measure |
Active Treatment
n=93 Participants
ENT-01 tablet will be taken once daily by mouth.
Active Investigational Treatment ENT-01: ENT-01 will be administered in tablet form, once daily.
|
Placebo Treatment
n=57 Participants
Placebo tablet will be taken once daily by mouth.
Placebo Treatment: Placebo will be administered in tablet form, once daily.
|
|---|---|---|
|
Change in Baseline Weekly CSBM-Primary Efficacy Endpoint
Baseline
|
1.1 spontaneous movements per week
Standard Deviation 1.01
|
1.0 spontaneous movements per week
Standard Deviation 1.05
|
|
Change in Baseline Weekly CSBM-Primary Efficacy Endpoint
Fixed Dose Period
|
3.9 spontaneous movements per week
Standard Deviation 3.43
|
2.3 spontaneous movements per week
Standard Deviation 2.49
|
Adverse Events
Active Treatment
Serious events: 0 serious events
Other events: 61 other events
Deaths: 0 deaths
Placebo Treatment
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Treatment
n=93 participants at risk
ENT-01 tablet will be taken once daily by mouth.
Active Investigational Treatment ENT-01: ENT-01 will be administered in tablet form, once daily.
|
Placebo Treatment
n=57 participants at risk
Placebo tablet will be taken once daily by mouth.
Placebo Treatment: Placebo will be administered in tablet form, once daily.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
7.5%
7/93 • Adverse events are collected once ICF signed through 30 post last dose of study medication (approximately 10 weeks plus 30 days post dose follow-up)
|
0.00%
0/57 • Adverse events are collected once ICF signed through 30 post last dose of study medication (approximately 10 weeks plus 30 days post dose follow-up)
|
|
Gastrointestinal disorders
Diarrhoea
|
19.4%
18/93 • Adverse events are collected once ICF signed through 30 post last dose of study medication (approximately 10 weeks plus 30 days post dose follow-up)
|
5.3%
3/57 • Adverse events are collected once ICF signed through 30 post last dose of study medication (approximately 10 weeks plus 30 days post dose follow-up)
|
|
Gastrointestinal disorders
Abdominal Pail
|
7.5%
7/93 • Adverse events are collected once ICF signed through 30 post last dose of study medication (approximately 10 weeks plus 30 days post dose follow-up)
|
5.3%
3/57 • Adverse events are collected once ICF signed through 30 post last dose of study medication (approximately 10 weeks plus 30 days post dose follow-up)
|
|
Gastrointestinal disorders
Nausea
|
34.4%
32/93 • Adverse events are collected once ICF signed through 30 post last dose of study medication (approximately 10 weeks plus 30 days post dose follow-up)
|
5.3%
3/57 • Adverse events are collected once ICF signed through 30 post last dose of study medication (approximately 10 weeks plus 30 days post dose follow-up)
|
|
Nervous system disorders
Dizziness
|
7.5%
7/93 • Adverse events are collected once ICF signed through 30 post last dose of study medication (approximately 10 weeks plus 30 days post dose follow-up)
|
1.8%
1/57 • Adverse events are collected once ICF signed through 30 post last dose of study medication (approximately 10 weeks plus 30 days post dose follow-up)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place