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

• Status: Completed
• Trial end date: 2019-11-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arkansas
• Treatments: Armodafinil; Modafinil

Criteria

Inclusion Criteria:

• Diagnosis of idiopathic PD on UK brain bank criteria.

• Presence of FOG based on objective assessment by the movement disorders neurologist.

• FOG-Q score > 8.

• Stable PD therapy (including medications and stimulation) for a period of 3 months prior to trial enrollment.

• Age ≥ 50 years.

Exclusion Criteria:

• Patients on antidopaminergic medications for a period of less than 1 year from date of enrollment.

• Patients who may require adjustment of their PD medications over the 6 month period of the trial.

• History of allergic reactions to Modafinil or armodafinil.

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, mitral valve prolapse, left ventricular hypertrophy, chronic obstructive pulmonary disease or psychiatric illness/social situations that would limit compliance with study requirements.

• Individuals who are pregnant or breastfeeding

• Non-english speaking individuals who are unable to complete the questionnaires and other assessments in English and/or follow instructions in English.