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NCT03713957 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment
A Phase 2 study of Parkinson Disease, sponsored by Alkahest.
- Completed
- Registry status
- Phase 2
- Development phase
- 79
- Enrollment target
- 20
- Study locations
NCT03713957: Completed Phase 2 study of Parkinson Disease, sponsored by Alkahest.
NCT03713957 is a Phase 2 study of Parkinson Disease that has completed, run by Alkahest. The registered enrollment target is 79 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03713957, a Phase 2 study of Parkinson Disease, has completed, sponsored by Alkahest.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 79 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety, tolerability, and potential effects on cognition of GRF6021, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects with Parkinson's disease and cognitive impairment.
Primary Outcome
Treatment-emergent adverse events identified by MedDRA preferred term and grouped by MedDRA System Organ Class
Conditions Studied
Interventions
- OTHER Placebo
- DRUG GRF6021
Study Locations (20)
Florida
- Moonshine Research Center - Doral
- Riverside Clinical Research - Edgewater
- MD Clinical - Hallandale
- Research Centers of America, LLC - Hollywood
- Suncoast Research Group, LLC - Miami
- Qps_Mra, Llc - South Miami
Georgia
- Atlanta Center for Medical Research - Atlanta
- NeuroTrials Research Inc. - Atlanta
Michigan
- Quest Research Institute - Farmington Hills
- SRI Biosciences - Plymouth
Texas
- UT Southwestern Medical Center - Dallas
- Centex Studies, INC. - Houston
Arkansas
- Clinical Trials, Inc. - Little Rock
Colorado
- Rocky Mountain Movement Disorders Center - Englewood
Missouri
- PsychCare Consultants Research - St Louis
North Carolina
- Wake Research - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2018-11-12 |
| Est. Completion | 2020-07-20 |
| Phase | Phase 2 |
What the finished NCT03713957 record still lists
NCT03713957 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Parkinson Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03713957 names 20 study sites across 12 states, led by Florida, Georgia, Michigan.
Frequently Asked Questions
What is clinical trial NCT03713957 about?
NCT03713957 is a clinical study titled "A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment". This study will evaluate the safety, tolerability, and potential effects on cognition of GRF6021, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects with Parkinson's disease and cognitive impairment.
What is the current status of trial NCT03713957?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 79 participants. The study started on 2018-11-12. Estimated completion is 2020-07-20.
What conditions does trial NCT03713957 study?
This clinical trial studies the following conditions: Parkinson Disease.
What interventions are being tested in trial NCT03713957?
The interventions under investigation include: Placebo (OTHER), GRF6021 (DRUG).
Who is sponsoring clinical trial NCT03713957?
This trial is sponsored by Alkahest, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03713957 being conducted?
This trial has 20 study locations across Arkansas, Colorado, Florida, Georgia, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Parkinson Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03713957's enrollment target sits among peer trials
79 110th of 297 higher than 188 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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