Trial Outcomes & Findings for Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety "Roll-over" Study (Rollover) (NCT NCT04483479)

Results Overview

Number of participants with Treatment Related Adverse Events

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

Through study treatment and completion up to 14 weeks

Results posted on

2024-03-19

Participant Flow

Participant milestones

Participant milestones
Measure	Active Treatment Orally Administered ENT-01 25mg Tablet Once Daily (Dose dependent on ENT-01-030 dose level stratification) Active Investigational Treatment ENT-01: ENT-01 will be administered in tablet form, once daily in escalating doses followed by a fixed-dose for 12 weeks.
Overall Study STARTED	27
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety "Roll-over" Study (Rollover)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Treatment n=27 Participants Orally Administered ENT-01 25mg Tablet Once Daily (Dose dependent on ENT-01-030 dose level stratification) Active Investigational Treatment ENT-01: ENT-01 will be administered in tablet form, once daily in escalating doses followed by a fixed-dose for 12 weeks.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=99 Participants
Age, Categorical >=65 years	24 Participants n=99 Participants
Sex: Female, Male Female	9 Participants n=99 Participants
Sex: Female, Male Male	18 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	27 Participants n=99 Participants
BMI	26.7 KG/m^2 STANDARD_DEVIATION 4.63 • n=99 Participants

PRIMARY outcome

Timeframe: Through study treatment and completion up to 14 weeks

Number of participants with Treatment Related Adverse Events

Outcome measures

Outcome measures
Measure	Active Treatment n=27 Participants Orally Administered ENT-01 25mg Tablet Once Daily (Dose dependent on ENT-01-030 dose level stratification) Active Investigational Treatment ENT-01: ENT-01 will be administered in tablet form, once daily in escalating doses followed by a fixed-dose for 12 weeks.
Number of Participants With Treatment Related Adverse Events	23 Participants

PRIMARY outcome

Timeframe: Through study treatment and completion up to 14 weeks

The number of participants with treatment related episodes of recurrent vomiting defined as 3-5 episodes of vomiting within 24 hours

Outcome measures

Outcome measures
Measure	Active Treatment n=27 Participants Orally Administered ENT-01 25mg Tablet Once Daily (Dose dependent on ENT-01-030 dose level stratification) Active Investigational Treatment ENT-01: ENT-01 will be administered in tablet form, once daily in escalating doses followed by a fixed-dose for 12 weeks.
Number of Participants With Treatment Related Recurrent Vomiting	5 Participants

PRIMARY outcome

Timeframe: Through study treatment and completion up to 14 weeks

The number of participants with treatment related episodes of recurrent diarrhea defined as 7 episodes of diarrhea within 24 hours for 2 consecutive days

Outcome measures

Outcome measures
Measure	Active Treatment n=27 Participants Orally Administered ENT-01 25mg Tablet Once Daily (Dose dependent on ENT-01-030 dose level stratification) Active Investigational Treatment ENT-01: ENT-01 will be administered in tablet form, once daily in escalating doses followed by a fixed-dose for 12 weeks.
Number of Participants With Treatment Related Recurrent Diarrhea	8 Participants

PRIMARY outcome

Timeframe: Through study treatment and completion up to 14 weeks

The number of participants with treatment related episodes of dizziness defined as lightheadedness or fainting on rising from lying to sitting or standing and severe enough to require non-urgent medical intervention within 24 hours

Outcome measures

Outcome measures
Measure	Active Treatment n=27 Participants Orally Administered ENT-01 25mg Tablet Once Daily (Dose dependent on ENT-01-030 dose level stratification) Active Investigational Treatment ENT-01: ENT-01 will be administered in tablet form, once daily in escalating doses followed by a fixed-dose for 12 weeks.
Number of Participants With Treatment Related Dizziness	8 Participants

Adverse Events

Active Treatment

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active Treatment n=27 participants at risk Orally Administered ENT-01 25mg Tablet Once Daily (Dose dependent on ENT-01-030 dose level stratification) Active Investigational Treatment ENT-01: ENT-01 will be administered in tablet form, once daily in escalating doses followed by a fixed-dose for 12 weeks.
Gastrointestinal disorders Nausea	59.3% 16/27 • 20 weeks
Gastrointestinal disorders Vomiting	18.5% 5/27 • 20 weeks
Gastrointestinal disorders Diarrhoea	29.6% 8/27 • 20 weeks
Nervous system disorders Tremors	7.4% 2/27 • 20 weeks
Investigations Weight Decreased	7.4% 2/27 • 20 weeks
Vascular disorders Dizziness	29.6% 8/27 • 20 weeks

Additional Information

Dr. Richard Larson, Chief Medical Officer

Enterin

Phone: 5054692670

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place