Modafinil for Freezing of Gait (FOG) in Parkinson's Disease (PD)
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 50 - 90 |
| Updated: | 7/18/2018 |
| Start Date: | June 13, 2017 |
| End Date: | October 2019 |
Modafinil as a Novel Therapy for the Treatment of Freezing of Gait in Parkinson's Disease
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.
20 subjects aged 18 or older with idiopathic Parkinson's disease with freezing of gait will
be asked to enroll in the study from the patient population in the movement disorders clinic
at the University of Arkansas for Medical Sciences (UAMS). Subjects will be assigned randomly
1:1 to an early start and delayed start arm of the study. In the early start arm subjects
will receive 24 weeks of 50 mg oral daily Modafinil while subjects in the delayed start arm
will receive 12 weeks of placebo followed by 12 weeks of 50 mg oral daily Modafinil.
Assessments will be performed prior to initiation of medication at the screening visit, as
well as at 6 weeks, 12 weeks, 18 weeks and 24 weeks of the treatment phase, in addition to 2
weeks after discontinuation of medications. The assessments will include questionnaires to
determine the frequency and severity of freezing of gait, level of mood, anxiety and apathy
and quality of life, physical examination and tests of cognitive function. Objective
assessment of patients walking will be conducted using a pressure sensor impregnated mat at
each visit.
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.
20 subjects aged 18 or older with idiopathic Parkinson's disease with freezing of gait will
be asked to enroll in the study from the patient population in the movement disorders clinic
at the University of Arkansas for Medical Sciences (UAMS). Subjects will be assigned randomly
1:1 to an early start and delayed start arm of the study. In the early start arm subjects
will receive 24 weeks of 50 mg oral daily Modafinil while subjects in the delayed start arm
will receive 12 weeks of placebo followed by 12 weeks of 50 mg oral daily Modafinil.
Assessments will be performed prior to initiation of medication at the screening visit, as
well as at 6 weeks, 12 weeks, 18 weeks and 24 weeks of the treatment phase, in addition to 2
weeks after discontinuation of medications. The assessments will include questionnaires to
determine the frequency and severity of freezing of gait, level of mood, anxiety and apathy
and quality of life, physical examination and tests of cognitive function. Objective
assessment of patients walking will be conducted using a pressure sensor impregnated mat at
each visit.
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.
We found this trial at
1
site
529 West Markham Street
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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