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RQ-00000010 for Gastroparesis and Constipation in Parkinson's Disease (RQ-10)

Primary Purpose

Parkinson's Disease, Gastroparesis, Constipation

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RQ-00000010
Placebo
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Gastroparesis, Constipation, Prokinetic, 5-HT4-receptor partial agonist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: For both the Single Ascending Dose and Multiple Ascending Dose studies: Idiopathic Parkinson's Disease (UK Brain Bank Criteria), Hoehn & Yahr stages 1-3, participants may be on oral levodopa, dopamine agonists, monoamine oxidase-B inhibitors, catechol-O-methyltransferase inhibitors, and amantadine, but doses must have remained stable for 28 days prior to enrollment and should be anticipated to remain stable throughout the study, participants may have deep brain stimulation (though stimulator settings must be expected to remain constant throughout the study) or ablative surgery for Parkinson's Disease.

Additional Inclusion criteria for the Multiple Ascending Dose study only: Must have symptoms suggestive of current gastroparesis or constipation as shown by any one or more of the following: 1. Need for regular use of prokinetics, laxatives, or stool softeners of any kind, 2. A total score of 2 or higher on the Gastroparesis Cardinal Symptoms Index (total score equals average of scores on the 3 subscales), 3. A score of 5 or higher on the gastroparesis subscale or 5 or higher on the constipation subscale of the Gastrointestinal Symptoms in Neurodegenerative Disease Scale.

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Exclusion Criteria: Dementia (Mini Mental Status Exam < 25), active psychosis, severe depression (score of 4 on question 1.3 of the Movement Disorder Society-United Parkinson Disease Rating Scale), active suicidality as measured by a most severe suicide ideation score of 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS), or patients who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items if the attempt or acts were performed within 1 year of screening, or patients who, in the opinion of the investigator, present a risk of suicide, any chronic gastrointestinal diseases except gastroesophageal reflux disease, history of any gastrointestinal surgery that might impact drug absorption (e.g. gastrectomy), use of apomorphine, anticholinergics, or carbidopa/levodopa intestinal gel for Parkinson's Disease, female participants who are pregnant or lactating, male or female participants of childbearing age who are not willing, or whose partners are not willing, to use contraception during the study, diabetes, symptomatic anemia, abnormal liver or kidney function, cardiac arrhythmia (past or present) or abnormal QT interval on entrance electrocardiogram, positive drug screen at screening visit, allergy to spirulina, egg, milk, or wheat, pulmonary dysfunction (e.g. Chronic Obstructive Pulmonary Disease), small bowel malabsorption, use of any medications affecting gastric emptying (macrolides, metoclopramide, domperidone, opiates, anticholinergics) within 3 days of visits 2 and 3, prisoners, and individuals with limited English proficiency.

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Sites / Locations

  • VCU NOW Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

RQ-00000010

Arm Description

For the single ascending dose study, subjects will receive a single dose of oral acetate buffer on a single day. For the multiple ascending dose study, subjects will receive a single daily dose of oral acetate buffer each day for 14 days.

For the single ascending dose study, subjects will receive a single dose of either: 2 micrograms, 50 micrograms or 200 micrograms of RQ-00000010 on a single day. For the multiple ascending dose study, subjects will receive single daily doses of either 10 micrograms, 50 micrograms or 100 vs. 200 micrograms of RQ-00000010 each day for 14 days.

Outcomes

Primary Outcome Measures

Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
adverse events, serious adverse events, electrocardiograms, physical exams, vital signs and safety labs

Secondary Outcome Measures

Gastric emptying
Carbon 13 Breath Test kit by Cairn Diagnostics
Area Under the Curve [AUC] for RQ-00000010 after single and multiple doses
Peak Plasma Concentration (Cmax) for RQ-00000010 after single and multiple doses

Full Information

First Posted
June 16, 2016
Last Updated
October 7, 2019
Sponsor
Virginia Commonwealth University
Collaborators
Michael J. Fox Foundation for Parkinson's Research, RaQualia Pharma Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02838797
Brief Title
RQ-00000010 for Gastroparesis and Constipation in Parkinson's Disease
Acronym
RQ-10
Official Title
RQ-00000010 for Gastroparesis and Constipation in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
August 20, 2019 (Actual)
Study Completion Date
August 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Michael J. Fox Foundation for Parkinson's Research, RaQualia Pharma Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a study to determine the safety and tolerability of a new medicine (RQ10) for gastrointestinal symptoms in Parkinson's disease. The investigators will also begin to look at the effect of this medicine on gastrointestinal problems. The results will determine if future studies are appropriate. In this study, RQ10 will be compared to a placebo (a look-alike inactive substance). Participation will include multiple office visits. Approximately 48 people will participate.
Detailed Description
This is a phase Ib study with the primary objectives of determining the safety and tolerability as well as pharmacokinetics after single ascending doses (SAD) and multiple ascending doses (MAD) of RQ10 in Parkinson's disease patients. A secondary objective will be to assess the impact of single doses of RQ10 on gastric emptying in Parkinson's Disease patients as well as the effects of RQ10 on gastroparesis symptoms. The expected results of this exploratory phase Ib study will allow deciding about whether to proceed with further development of RQ10 in Parkinson's Disease patients ("go-no go") and help design a formal phase IIa "proof of concept" study by informing repeat-dose selection and possible effect sizes in Parkinson's Disease patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Gastroparesis, Constipation
Keywords
Parkinson's disease, Gastroparesis, Constipation, Prokinetic, 5-HT4-receptor partial agonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
For the single ascending dose study, subjects will receive a single dose of oral acetate buffer on a single day. For the multiple ascending dose study, subjects will receive a single daily dose of oral acetate buffer each day for 14 days.
Arm Title
RQ-00000010
Arm Type
Experimental
Arm Description
For the single ascending dose study, subjects will receive a single dose of either: 2 micrograms, 50 micrograms or 200 micrograms of RQ-00000010 on a single day. For the multiple ascending dose study, subjects will receive single daily doses of either 10 micrograms, 50 micrograms or 100 vs. 200 micrograms of RQ-00000010 each day for 14 days.
Intervention Type
Drug
Intervention Name(s)
RQ-00000010
Intervention Description
orally administered serotonin 4 receptor partial agonist
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral acetate buffer
Primary Outcome Measure Information:
Title
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Description
adverse events, serious adverse events, electrocardiograms, physical exams, vital signs and safety labs
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Gastric emptying
Description
Carbon 13 Breath Test kit by Cairn Diagnostics
Time Frame
1 hour after RQ10 dosing
Title
Area Under the Curve [AUC] for RQ-00000010 after single and multiple doses
Time Frame
18 months
Title
Peak Plasma Concentration (Cmax) for RQ-00000010 after single and multiple doses
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For both the Single Ascending Dose and Multiple Ascending Dose studies: Idiopathic Parkinson's Disease (UK Brain Bank Criteria), Hoehn & Yahr stages 1-3, participants may be on oral levodopa, dopamine agonists, monoamine oxidase-B inhibitors, catechol-O-methyltransferase inhibitors, and amantadine, but doses must have remained stable for 28 days prior to enrollment and should be anticipated to remain stable throughout the study, participants may have deep brain stimulation (though stimulator settings must be expected to remain constant throughout the study) or ablative surgery for Parkinson's Disease. Additional Inclusion criteria for the Multiple Ascending Dose study only: Must have symptoms suggestive of current gastroparesis or constipation as shown by any one or more of the following: 1. Need for regular use of prokinetics, laxatives, or stool softeners of any kind, 2. A total score of 2 or higher on the Gastroparesis Cardinal Symptoms Index (total score equals average of scores on the 3 subscales), 3. A score of 5 or higher on the gastroparesis subscale or 5 or higher on the constipation subscale of the Gastrointestinal Symptoms in Neurodegenerative Disease Scale. - Exclusion Criteria: Dementia (Mini Mental Status Exam < 25), active psychosis, severe depression (score of 4 on question 1.3 of the Movement Disorder Society-United Parkinson Disease Rating Scale), active suicidality as measured by a most severe suicide ideation score of 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS), or patients who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items if the attempt or acts were performed within 1 year of screening, or patients who, in the opinion of the investigator, present a risk of suicide, any chronic gastrointestinal diseases except gastroesophageal reflux disease, history of any gastrointestinal surgery that might impact drug absorption (e.g. gastrectomy), use of apomorphine, anticholinergics, or carbidopa/levodopa intestinal gel for Parkinson's Disease, female participants who are pregnant or lactating, male or female participants of childbearing age who are not willing, or whose partners are not willing, to use contraception during the study, diabetes, symptomatic anemia, abnormal liver or kidney function, cardiac arrhythmia (past or present) or abnormal QT interval on entrance electrocardiogram, positive drug screen at screening visit, allergy to spirulina, egg, milk, or wheat, pulmonary dysfunction (e.g. Chronic Obstructive Pulmonary Disease), small bowel malabsorption, use of any medications affecting gastric emptying (macrolides, metoclopramide, domperidone, opiates, anticholinergics) within 3 days of visits 2 and 3, prisoners, and individuals with limited English proficiency. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Cloud, MD, MSc
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VCU NOW Center
City
Henrico
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States

12. IPD Sharing Statement

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RQ-00000010 for Gastroparesis and Constipation in Parkinson's Disease

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