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Modafinil for Freezing of Gait (FOG) in Parkinson's Disease (PD)

NCT03083132 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-10-27

Study results available
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Summary

Freezing of gait is a late stage complication of Parkinson's disease in which patients note that their feet feel stuck or glued to the ground. This can lead to imbalance and falls and the secondary complications that can result from falls such as fractures and hospitalizations. While levodopa can help freezing of gait in some patients, it does not help in all, and the dose needed to treat freezing may be limited by side effects of the medications. Currently there are no treatments targeted towards freezing of gait and the goal of this research is to see if Modafinil could be one such drug to help freezing of gait in Parkinson's disease.

Conditions

  • Parkinson Disease

Interventions

DRUG

modafinil 50mg

1 capsule oral daily

DRUG

Placebo oral capsule

1 capsule oral daily

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Tuhin Virmani, MD, PhD · University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-13
Primary Completion
2019-11-12
Completion
2019-11-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03083132 on ClinicalTrials.gov