This study will be conducted as an open-label safety follow-on to a multi-center, double-blind, randomized study. All subjects who participated in the randomized study will be offered participation in this unblinded, single-arm, safety study. Approximately 50 subjects will be entered into the study and ENT-01 will be administered daily in escalating doses followed by a fixed dose for 12 weeks. Each subject will participate for approximately 20 weeks; dosing duration will be approximately 14 weeks.
The study will be conducted on an out-patient or in-patient basis with visits performed at the screening visit, at 6 and 12 weeks, and at the end of the 6th week of the wash-out period (end of study). The dose escalation period will last up to 20 days, the fixed dose period will last 12 weeks, and the wash-out period will last 6 weeks. Subjects will begin dosing at the same dose level they were stratified to in the ENT-01-030 randomized study (i.e., starting at either 3 tablets or 6 tablets,) and escalate up to a pro-kinetic dose or a maximum dose of 250mg.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
ENT-01 will be administered in tablet form, once daily in escalating doses followed by a fixed-dose for 12 weeks.
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States
Number of Participants With Treatment Related Adverse Events
Number of participants with Treatment Related Adverse Events
Time frame: Through study treatment and completion up to 14 weeks
Number of Participants With Treatment Related Recurrent Vomiting
The number of participants with treatment related episodes of recurrent vomiting defined as 3-5 episodes of vomiting within 24 hours
Time frame: Through study treatment and completion up to 14 weeks
Number of Participants With Treatment Related Recurrent Diarrhea
The number of participants with treatment related episodes of recurrent diarrhea defined as 7 episodes of diarrhea within 24 hours for 2 consecutive days
Time frame: Through study treatment and completion up to 14 weeks
Number of Participants With Treatment Related Dizziness
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
Time frame: Through study treatment and completion up to 14 weeks
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