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

NCT03083132 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 206341
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

freezing of gait

Outcome Measures

Primary Outcomes (2)

• Mean Change From Baseline Freezing of Gait (FOG) After First 12 Weeks of Treatment, as Measured by the Giladi Freezing of Gait Questionnaire (FOG-Q).

  The freezing of gait questionnaire (FOG-Q) was administered by a movement disorders neurologist at baseline (week 0), and again after taking the randomly assigned treatment (either Modafinil or placebo) for 12 weeks. The FOG-Q scores 6 items between 0 and 4, for a total score of 24; higher values indicate worse FOG.

  12 weeks

• Mean Change From Baseline Stride Length After 12 Weeks on Treatment, as Measured Using an Instrumented Gait Mat.

  Participants walked on a 20 foot instrumented gait mat for a total of 80 feet, first at baseline (week 0), and again after taking the randomly assigned treatment (either Modafinil or placebo) for 12 weeks. The stride length values usually range between 0 and 160 centimeters (the maximum stride length we have seen in an aging healthy population); lower values typically indicate more shuffling gait and have been associated with greater gait instability.

  12 weeks

Secondary Outcomes (4)

• Mean Change From Baseline in Motor Function After 12 Weeks on Treatment, as Measured by the Unified Parkinson's Disease Rating Scale Motor Score (UPDRS-III).

  12 weeks

• Mean Change From Baseline Quality of Life After 12 Weeks on Treatment, as Measured by the Parkinson's Disease Questionnaire-39 (PDQ-39).

  12 weeks

• Mean Change From Baseline Sleep Quality After 12 Weeks on Treatment, as Measured by the REM Sleep Behavior Disorder Questionnaire (RBD-Q).

  12 weeks

• Mean Change From Baseline Sleep Quality After 12 Weeks on Treatment, as Measured by the Epworth Sleepiness Scale (ESS).

  12 weeks

Study Arms (2)

Early-start

ACTIVE COMPARATOR

24 weeks of modafinil 50 mg oral daily

Drug: modafinil 50mg

Delayed-start

PLACEBO COMPARATOR

12 weeks of oral placebo followed by 12 weeks of modafinil 50 mg oral daily

Drug: modafinil 50mg; Drug: Placebo oral capsule

Interventions

modafinil 50mg DRUG

1 capsule oral daily

Delayed-start; Early-start

Placebo oral capsule DRUG

1 capsule oral daily

Delayed-start

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Tuhin Virmani
• Organization: University of Arkansas for Medical Sciences

tvirmani@uams.edu

501-686-7235

Study Officials

• Tuhin Virmani, MD, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled delayed start

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 17, 2017
• Study Start: June 13, 2017
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2019
• Last Updated: October 27, 2021
• Results First Posted: October 27, 2021

Record last verified: 2021-08

Locations

US (1)