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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.
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.
Approximately 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 12 weeks of the treatment phase. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early-start | Active Comparator | 24 weeks of modafinil 50 mg oral daily |
|
| Delayed-start | Placebo Comparator | 12 weeks of oral placebo followed by 12 weeks of modafinil 50 mg oral daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modafinil 50mg | Drug | 1 capsule oral daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | For each participant, the Unified Parkinson's disease Rating scale (UPDRS) was administered by a movement disorders neurologist. The scale was first administered at baseline (week 0), and again after taking the randomly assigned treatment (either Modafinil or placebo) for 12 weeks. The motor subscale of the UPDRS takes integer values between 0 and 4 for each of the 27 items for a total maximum score of 108; higher values indicate worse motor function. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tuhin Virmani, MD, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Early-start | 24 weeks of modafinil 50 mg oral daily modafinil 50mg: 1 capsule oral daily |
| FG001 | Delayed-start | 12 weeks of oral placebo followed by 12 weeks of modafinil 50 mg oral daily modafinil 50mg: 1 capsule oral daily Placebo oral capsule: 1 capsule oral daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First 12 Weeks (Placebo vs Modafinil) |
|
| ||||||||||||||||||
| Last 12 Weeks (Drug for All Subjects) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Early-start | 24 weeks of modafinil 50 mg oral daily modafinil 50mg: 1 capsule oral daily |
| BG001 | Delayed-start | 12 weeks of oral placebo followed by 12 weeks of modafinil 50 mg oral daily modafinil 50mg: 1 capsule oral daily Placebo oral capsule: 1 capsule oral daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants that completed the placebo controlled portion of the study (first 12 weeks of the study) | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
Period of the trial (30 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early-start | 24 weeks of modafinil 50 mg oral daily modafinil 50mg: 1 capsule oral daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cervical stenosis | Nervous system disorders | Systematic Assessment | Participant was diagnosed with cervical stenosis during the course of the trial and underwent surgical procedure. As a result it was determined appropriate for him to discontinue further study assessments. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| lower extremity edema | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tuhin Virmani | University of Arkansas for Medical Sciences | 501-686-7235 | tvirmani@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 28, 2017 | Sep 28, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Randomized, placebo-controlled delayed start
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| Placebo oral capsule |
| Drug |
1 capsule oral daily |
|
| 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). | For each participant, the Parkinson's Disease Questionnaire (PDQ-39) was self-administered by participants. The questionnaire was first administered at baseline (week 0), and again after taking the randomly assigned treatment (either Modafinil or placebo) for 12 weeks. The PDQ-39 scores takes integer values between 0 and 4, for each of the 39 items for a total maximum score of 156; higher values indicate worse quality of life. | 12 weeks |
| Mean Change From Baseline Sleep Quality After 12 Weeks on Treatment, as Measured by the REM Sleep Behavior Disorder Questionnaire (RBD-Q). | For each participant, the REM sleep behavior disorder questionnaire (RBD-Q) was self-administered by participants. The questionnaires were first administered at baseline (week 0), and again after taking the randomly assigned treatment (either Modafinil or placebo) for 12 weeks. The RBD-Q score takes integer values between 0 and 1, for each of the 13 item yes/no questions for a total maximum score of 13; higher values indicate worse sleep behavior disorder. | 12 weeks |
| Mean Change From Baseline Sleep Quality After 12 Weeks on Treatment, as Measured by the Epworth Sleepiness Scale (ESS). | For each participant, the Epworth Sleepiness Scale (ESS) questionnaires was self-administered by participants. The questionnaires were first administered at baseline (week 0), and again after taking the randomly assigned treatment (either Modafinil or placebo) for 12 weeks. The ESS takes integer values between 0 and 3, for each of the 8 items for a total maximum score of 24; higher values indicate more daytime sleepiness. | 12 weeks |
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|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Freezing of Gait Questionnaire (FOG-Q) | The freezing of gait questionnaire (FOG-Q) was administered by a movement disorders neurologist. The FOG-Q scores 6 items between 0 and 4, for a total score of 24; higher values indicate worse FOG. | Mean | Standard Deviation | units on a scale |
|
| Gait stride length (cm) | Participants walked on a 20 foot instrumented gait mat for a total of 80 feet. The stride length was measured as the distance between two consecutive footsteps (for example right foot step to the next right footstep). The combined average stride length for both right and left feet are reported. 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. | Mean | Standard Deviation | cms |
|
| motor Unified Parkinson's Disease Rating Scale (UPDRS) score | The motor Unified Parkinson's disease Rating scale (UPDRS) was administered by a movement disorders neurologist. The scale was administered in the levodopa-OFF state first at baseline (week 0), and again after taking the randomly assigned treatment (either Modafinil or placebo) for 12 weeks. The motor subscale of the UPDRS takes integer values between 0 and 4 for each of the 27 items for a total maximum score of 108; higher values indicate worse motor function. | Mean | Standard Deviation | units on a scale |
|
| Parkinson's Disease Questionnaire-39 (PDQ-39) | The Parkinson's Disease Questionnaire-39 (PDQ-39) was self-administered by participants. The PDQ-39 scores takes integer values between 0 and 4, for each of the 39 items for a total maximum score of 156; higher values indicate worse quality of life. | Mean | Standard Deviation | units on a scale |
|
| REM sleep Behavior Disorder Questionnaire (RBD-Q) | The REM sleep behavior disorder questionnaire (RBD-Q) was self administered by participants and measures the presence and severity of REM sleep behavior disorder. The RBD-Q maximum score is 13. Higher values indicate worse symptoms. | Mean | Standard Deviation | units on a scale |
|
| Epworth Sleepiness Scale (ESS) score | The Epworth Sleepiness Scale (ESS) was self administered by participants and measures the level of daytime sleepiness. The ESS maximum score is 24. Higher values indicate worse symptoms. | Mean | Standard Deviation | units on a scale |
|
| Delayed-start |
12 weeks of oral placebo followed by 12 weeks of modafinil 50 mg oral daily modafinil 50mg: 1 capsule oral daily Placebo oral capsule: 1 capsule oral daily |
|
|
| Primary | 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. | Participants that completed the placebo controlled portion of the study (first 12 weeks) | Posted | Mean | Standard Deviation | cms | 12 weeks |
|
|
|
| Secondary | 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). | For each participant, the Unified Parkinson's disease Rating scale (UPDRS) was administered by a movement disorders neurologist. The scale was first administered at baseline (week 0), and again after taking the randomly assigned treatment (either Modafinil or placebo) for 12 weeks. The motor subscale of the UPDRS takes integer values between 0 and 4 for each of the 27 items for a total maximum score of 108; higher values indicate worse motor function. | Subjects who completed the first 12 weeks of the study | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| Secondary | Mean Change From Baseline Quality of Life After 12 Weeks on Treatment, as Measured by the Parkinson's Disease Questionnaire-39 (PDQ-39). | For each participant, the Parkinson's Disease Questionnaire (PDQ-39) was self-administered by participants. The questionnaire was first administered at baseline (week 0), and again after taking the randomly assigned treatment (either Modafinil or placebo) for 12 weeks. The PDQ-39 scores takes integer values between 0 and 4, for each of the 39 items for a total maximum score of 156; higher values indicate worse quality of life. | Participants that completed the placebo controlled portion of the study (first 12 weeks) | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| Secondary | Mean Change From Baseline Sleep Quality After 12 Weeks on Treatment, as Measured by the REM Sleep Behavior Disorder Questionnaire (RBD-Q). | For each participant, the REM sleep behavior disorder questionnaire (RBD-Q) was self-administered by participants. The questionnaires were first administered at baseline (week 0), and again after taking the randomly assigned treatment (either Modafinil or placebo) for 12 weeks. The RBD-Q score takes integer values between 0 and 1, for each of the 13 item yes/no questions for a total maximum score of 13; higher values indicate worse sleep behavior disorder. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| Secondary | Mean Change From Baseline Sleep Quality After 12 Weeks on Treatment, as Measured by the Epworth Sleepiness Scale (ESS). | For each participant, the Epworth Sleepiness Scale (ESS) questionnaires was self-administered by participants. The questionnaires were first administered at baseline (week 0), and again after taking the randomly assigned treatment (either Modafinil or placebo) for 12 weeks. The ESS takes integer values between 0 and 3, for each of the 8 items for a total maximum score of 24; higher values indicate more daytime sleepiness. | Participants that completed the placebo controlled portion of the study (first 12 weeks) | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| 12 |
| 12 |
| EG001 | Delayed-start | 12 weeks of oral placebo followed by 12 weeks of modafinil 50 mg oral daily modafinil 50mg: 1 capsule oral daily Placebo oral capsule: 1 capsule oral daily | 0 | 9 | 0 | 9 | 9 | 9 |
|
| dyspnea on exertion | Cardiac disorders | Systematic Assessment |
|
| palpitations | Cardiac disorders | Systematic Assessment |
|
| lightheadedness on standing | Cardiac disorders | Systematic Assessment |
|
| dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| facial rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| skin tag | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| cold intolerance | Endocrine disorders | Systematic Assessment |
|
| diagnosed with diabetes | Endocrine disorders | Systematic Assessment |
|
| rhinorrhea | General disorders | Systematic Assessment |
|
| allergy flare | General disorders | Systematic Assessment |
|
| lower eyelid edema | Eye disorders | Systematic Assessment |
|
| tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| hyperphagia | Metabolism and nutrition disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| calf pain/cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| bursitis/epicondylitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| neck stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| paresthesias | Nervous system disorders | Systematic Assessment |
|
| morning grogginess | Nervous system disorders | Systematic Assessment |
|
| daytime sleepiness | Nervous system disorders | Systematic Assessment |
|
| insomnia | Nervous system disorders | Systematic Assessment |
|
| falls | Nervous system disorders | Systematic Assessment |
|
| sciatica | Nervous system disorders | Systematic Assessment |
|
| daytime confusion | Nervous system disorders | Systematic Assessment |
|
| dysphagia | Nervous system disorders | Systematic Assessment |
|
| fatigue | Nervous system disorders | Systematic Assessment |
|
| hallucinations | Nervous system disorders | Systematic Assessment |
|
| hand cramps | Nervous system disorders | Systematic Assessment |
|
| freezing of gait | Nervous system disorders | Systematic Assessment |
|
| headaches | Nervous system disorders | Systematic Assessment |
|
| imbalance | Nervous system disorders | Systematic Assessment |
|
| difficulty getting out of bed | Nervous system disorders | Systematic Assessment |
|
| difficulty with ADLs | Nervous system disorders | Systematic Assessment |
|
| slowed gait | Nervous system disorders | Systematic Assessment |
|
| toe walking | Nervous system disorders | Systematic Assessment |
|
| word finding difficulty | Nervous system disorders | Systematic Assessment |
|
| lacrimation | Eye disorders | Systematic Assessment |
|
| visual floaters/flashing | Eye disorders | Systematic Assessment |
|
| blurred vision | Eye disorders | Systematic Assessment |
|
| anxiety | Psychiatric disorders | Systematic Assessment |
|
| depressed mood | Psychiatric disorders | Systematic Assessment |
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| irritability | Psychiatric disorders | Systematic Assessment |
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| nocturia | Renal and urinary disorders | Systematic Assessment |
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| nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
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| urinary incontinance | Renal and urinary disorders | Systematic Assessment |
|
| urinary tract infection | Infections and infestations | Systematic Assessment |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |