ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 26 of 43 for:    Recruiting, Not yet recruiting, Available Studies | "Gastroparesis"

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02838797
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : April 3, 2018
Sponsor:
Collaborators:
Michael J. Fox Foundation for Parkinson's Research
RaQualia Pharma Inc.
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Gastroparesis Constipation Drug: RQ-00000010 Drug: Placebo Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: RQ-00000010 for Gastroparesis and Constipation in Parkinson's Disease
Study Start Date : June 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Drug: Placebo
oral acetate buffer

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.

Drug: RQ-00000010
orally administered serotonin 4 receptor partial agonist




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Gastric emptying [ Time Frame: 1 hour after RQ10 dosing ]
    Carbon 13 Breath Test kit by Cairn Diagnostics

  2. Area Under the Curve [AUC] for RQ-00000010 after single and multiple doses [ Time Frame: 18 months ]
  3. Peak Plasma Concentration (Cmax) for RQ-00000010 after single and multiple doses [ Time Frame: 18 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

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): NCT02838797


Contacts
Contact: Leslie Cloud, MD, MSc leslie.cloud@vcuhealth.org
Contact: Ginger Norris, MGC 804-627-1398 virginia.norris@vcuhealth.org

Locations
United States, Virginia
VCU NOW Center Recruiting
Henrico, Virginia, United States, 23233
Contact: Ginger Norris    804-627-1398    virginia.norris@vcuhealth.org   
Principal Investigator: Leslie J Cloud, MD, MSc         
Sponsors and Collaborators
Virginia Commonwealth University
Michael J. Fox Foundation for Parkinson's Research
RaQualia Pharma Inc.
Investigators
Principal Investigator: Leslie Cloud, MD, MSc Virginia Commonwealth University

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02838797     History of Changes
Other Study ID Numbers: HM20001657
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018

Keywords provided by Virginia Commonwealth University:
Parkinson's disease
Gastroparesis
Constipation
Prokinetic
5-HT4-receptor partial agonist

Additional relevant MeSH terms:
Gastroparesis
Parkinson Disease
Constipation
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations