RQ-10 in PD

RQ-00000010 for Gastroparesis and constipation in Parkinson's disease

Recruitment Information:

Seeking volunteers with following diagnosis: PD Study Type: Interventional
Eligible Ages: 18 - 100 Status: Enrolling by invitation
Time Since Diagnosis: Any may be eligible Study Focus: Constipation/Bladder Problems

Study Purpose:

This is a study to determine the safety and tolerability of a new medicine for GI symptoms in Parkinson's disease (RQ10). We will also begin to look at the effect of this medicine on GI 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.

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More Details

This is a phase Ib study with the primary objectives of determining the safety and tolerability as well as PK 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 PD 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 PD 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 PD patients.

Phase: Phase 1 Lead Sponsor: Michael J. Fox Foundation
Trial ID: 004636 Sponsor Type: Nonprofit
Primary Country: United States Additional Collaborators or Sponsors: RaQualia Pharma Inc.
Estimated Enrollment: 75 Study Start Date: June 2016
Estimated Study Completion Date: March 2019 Source:
Study Website:
This is a FDA Regulated Trial

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