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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02838797
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : October 9, 2019
Sponsor:
Collaborators:
Michael J. Fox Foundation for Parkinson's Research
RaQualia Pharma Inc.
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE June 16, 2016
First Posted Date  ICMJE July 20, 2016
Last Update Posted Date October 9, 2019
Actual Study Start Date  ICMJE June 2016
Actual Primary Completion Date August 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2016)
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment [ Time Frame: 18 months ]
adverse events, serious adverse events, electrocardiograms, physical exams, vital signs and safety labs
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment [ Time Frame: 18 months ]
adverse events, serious adverse events, ECGs, physical exams, vital signs and safety labs
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
  • Gastric emptying [ Time Frame: 1 hour after RQ10 dosing ]
    Carbon 13 Breath Test kit by Cairn Diagnostics
  • Area Under the Curve [AUC] for RQ-00000010 after single and multiple doses [ Time Frame: 18 months ]
  • Peak Plasma Concentration (Cmax) for RQ-00000010 after single and multiple doses [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RQ-00000010 for Gastroparesis and Constipation in Parkinson's Disease
Official Title  ICMJE RQ-00000010 for Gastroparesis and Constipation in Parkinson's Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Parkinson's Disease
  • Gastroparesis
  • Constipation
Intervention  ICMJE
  • Drug: RQ-00000010
    orally administered serotonin 4 receptor partial agonist
  • Drug: Placebo
    oral acetate buffer
Study Arms  ICMJE
  • Placebo Comparator: Placebo

    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.

    Intervention: Drug: Placebo
  • Experimental: RQ-00000010

    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: Drug: RQ-00000010
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2019)
51
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2016)
75
Actual Study Completion Date  ICMJE August 20, 2019
Actual Primary Completion Date August 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02838797
Other Study ID Numbers  ICMJE HM20001657
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE
  • Michael J. Fox Foundation for Parkinson's Research
  • RaQualia Pharma Inc.
Investigators  ICMJE
Principal Investigator: Leslie Cloud, MD, MSc Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP