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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02838797
• Date of registration: 16/06/2016
• Prospective Registration: No
• Primary sponsor: Virginia Commonwealth University
• Public title: RQ-00000010 for Gastroparesis and Constipation in Parkinson's Disease RQ-10
• Scientific title: RQ-00000010 for Gastroparesis and Constipation in Parkinson's Disease
• Date of first enrolment: June 2016
• Target sample size: 51
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02838797
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Leslie Cloud, MD, MSc
• Affiliation: Virginia Commonwealth University

Key inclusion & exclusion 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.

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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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Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Constipation

Parkinson's Disease

Gastroparesis

Intervention(s)

Drug: Placebo

Drug: RQ-00000010

Primary Outcome(s)

Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment [Time Frame: 18 months]

Secondary Outcome(s)

Area Under the Curve [AUC] for RQ-00000010 after single and multiple doses [Time Frame: 18 months]

Gastric emptying [Time Frame: 1 hour after RQ10 dosing]

Peak Plasma Concentration (Cmax) for RQ-00000010 after single and multiple doses [Time Frame: 18 months]

Secondary ID(s)

HM20001657

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

RaQualia Pharma Inc.

Michael J. Fox Foundation for Parkinson's Research