Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety "Roll-over" Study (Rollover) (Rollover)
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|ClinicalTrials.gov Identifier: NCT04483479|
Recruitment Status : Recruiting
First Posted : July 23, 2020
Last Update Posted : September 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Constipation||Drug: Active Investigational Treatment ENT-01||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a Phase 2b, non-randomized, open-label study.|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Non-Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Orally Administered ENT-01 in Improving Constipation and Neurologic Symptoms in Patients With Parkinson's Disease and Constipation Over a 14-week Period|
|Actual Study Start Date :||July 30, 2020|
|Estimated Primary Completion Date :||November 1, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Active Treatment
Orally Administered ENT-01 25mg Tablet Once Daily (Dose dependent on ENT-01-030 dose level stratification)
Drug: 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.
Other Name: ENT-01
- Incidence of Treatment Related Adverse Events - Primary SAFETY Endpoint [ Time Frame: Through study treatment and completion up to 14 weeks ]The number of treatment related adverse events as evaluated with subject report, vital signs, chemical chemistry and electrocardiograms (EKG)
- Incidence of Treatment Related Recurrent Vomiting - TOLERABILITY Endpoints [ Time Frame: Through study treatment and completion up to 14 weeks ]The number of treatment related episodes of recurrent vomiting defined as 3-5 episodes of vomiting within 24 hours.
- Incidence of Treatment Related Recurrent Diarrhea - TOLERABILITY Endpoints [ Time Frame: Through study treatment and completion up to 14 weeks ]The number of treatment related episodes of recurrent diarrhea defined as 7 episodes of diarrhea within 24 hours for 2 consecutive days.
- Incidence of Treatment Related Dizziness - TOLERABILITY Endpoints [ Time Frame: Through study treatment and completion up to 14 weeks ]The number of 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.
- Change in Baseline Weekly CSBM Rate - Primary EFFICACY Endpoint [ Time Frame: Through study treatment up to 12 weeks ]Change from baseline in weekly CSBM rate during the 12 weeks of treatment over baseline.
- MDS-UPDRS - Secondary EFFICACY Endpoints [ Time Frame: Through study treatment up to 12 weeks ]Change from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score at the end of the 12-week fixed dose period. Score range: 0-272. Higher score indicates increased disease severity.
- MMSE - Secondary EFFICACY Endpoints [ Time Frame: Through study treatment up to 12 weeks ]Change from baseline in cognition as assessed by the Mini-Mental State Examination (MMSE) at the 12-week fixed dose period. Score range: 0-30. Below the score of 24, lower score indicates an increasing severity of cognitive impairment.
- SAPS-PD - Secondary EFFICACY Endpoints [ Time Frame: Through study treatment up to 12 weeks ]Change from baseline in psychosis as assessed by the Scale for the Assessment of Positive Symptoms for Parkinson's Disease Psychosis (SAPS-PD) score at the 12-week fixed dose period. Score range: 0-45. Higher score indicates increased presence of psychosis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04483479
|Contact: Denise Barbut, MD, FRCP||215 634 9243||KARMETinfo@enterininc.com|
|Study Chair:||Michael Zasloff, MD, PhD||Enterin Inc.|
|Study Director:||Denise Barbut, MD, FRCP||Enterin Inc.|