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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03083132
• Date of registration: 07/03/2017
• Prospective Registration: Yes
• Primary sponsor: University of Arkansas
• Public title: Modafinil for Freezing of Gait (FOG) in Parkinson's Disease (PD)
• Scientific title: Modafinil as a Novel Therapy for the Treatment of Freezing of Gait in Parkinson's Disease
• Date of first enrolment: June 13, 2017
• Target sample size: 23
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03083132
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Early Phase 1

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: 50 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Placebo oral capsule

Drug: modafinil 50mg

Primary Outcome(s)

FOG-Q [Time Frame: 12 weeks]

Secondary ID(s)

206341

Source(s) of Monetary Support

Please refer to primary and secondary sponsors