Parkinson DiseasePhase 2NCT03083132
Modafinil for Freezing of Gait (FOG) in Parkinson's Disease (PD)
A Phase 2 study testing modafinil 50mg in people with Parkinson Disease, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- modafinil 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2017to 12 Nov 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Parkinson Disease
- Being tested
- modafinil 50mg, Placebo oral capsule
- Keywords
- freezing of gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modafinil 50mgDrug
1 capsule oral daily
Placebo oral capsuleDrug
1 capsule oral daily
| Study group | Role | What they receive |
|---|---|---|
| Early-start | Active comparator | 24 weeks of modafinil 50 mg oral daily Receives: Drug: modafinil 50mg |
| Delayed-start | Placebo comparator | 12 weeks of oral placebo followed by 12 weeks of modafinil 50 mg oral daily Receives: Drug: modafinil 50mg; Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start13 Jun 2017
- Primary completion12 Nov 2019
- Study completion12 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled delayed start
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tuhin Virmani, MD, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083132
- Sponsor's protocol ID
- 206341
- Status last verified
- Aug 2021
- First submitted
- 7 Mar 2017
- Last updated
- 27 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modafinil as a Novel Therapy for the Treatment of Freezing of Gait in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03083132
- Acronym / sponsor ID
- 206341
- Conditions
- Parkinson Disease
- Keywords
- freezing of gait
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 12 Nov 2019 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Posted 27 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, placebo-controlled delayed start
| Arm | Type | Receives |
|---|---|---|
| Early-start | Active comparator | Drug: modafinil 50mg24 weeks of modafinil 50 mg oral daily |
| Delayed-start | Placebo comparator | Drug: modafinil 50mg, Drug: Placebo oral capsule12 weeks of oral placebo followed by 12 weeks of modafinil 50 mg oral daily |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modafinil 50mg1 capsule oral daily | Drug | Delayed-start, Early-start |
| Placebo oral capsule1 capsule oral daily | Drug | Delayed-start |
Primary outcome
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).
Time frame: 12 weeks
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.
Mean Change From Baseline Stride Length After 12 Weeks on Treatment, as Measured Using an Instrumented Gait Mat.
Time frame: 12 weeks
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.
4 secondary outcomes
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).
Time frame: 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).
Time frame: 12 weeks
Mean Change From Baseline Sleep Quality After 12 Weeks on Treatment, as Measured by the REM Sleep Behavior Disorder Questionnaire (RBD-Q).
Time frame: 12 weeks
Mean Change From Baseline Sleep Quality After 12 Weeks on Treatment, as Measured by the Epworth Sleepiness Scale (ESS).
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuhin Virmani, MD, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing modafinil 50mg in people with Parkinson Disease, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.