Trial Outcomes & Findings for Modafinil for Freezing of Gait (FOG) in Parkinson's Disease (PD) (NCT NCT03083132)
NCT ID: NCT03083132
Last Updated: 2021-10-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-10-27
Participant Flow
Participant milestones
| Measure |
Early-start
24 weeks of modafinil 50 mg oral daily
modafinil 50mg: 1 capsule oral daily
|
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
|
|---|---|---|
|
First 12 Weeks (Placebo vs Modafinil)
STARTED
|
12
|
9
|
|
First 12 Weeks (Placebo vs Modafinil)
COMPLETED
|
12
|
7
|
|
First 12 Weeks (Placebo vs Modafinil)
NOT COMPLETED
|
0
|
2
|
|
Last 12 Weeks (Drug for All Subjects)
STARTED
|
12
|
7
|
|
Last 12 Weeks (Drug for All Subjects)
COMPLETED
|
11
|
6
|
|
Last 12 Weeks (Drug for All Subjects)
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Early-start
24 weeks of modafinil 50 mg oral daily
modafinil 50mg: 1 capsule oral daily
|
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
|
|---|---|---|
|
First 12 Weeks (Placebo vs Modafinil)
Withdrawal by Subject
|
0
|
2
|
|
Last 12 Weeks (Drug for All Subjects)
Physician Decision
|
1
|
0
|
|
Last 12 Weeks (Drug for All Subjects)
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Modafinil for Freezing of Gait (FOG) in Parkinson's Disease (PD)
Baseline characteristics by cohort
| Measure |
Early-start
n=12 Participants
24 weeks of modafinil 50 mg oral daily
modafinil 50mg: 1 capsule oral daily
|
Delayed-start
n=9 Participants
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
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.6 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
72.9 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
72.1 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
9 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Freezing of Gait Questionnaire (FOG-Q)
|
13.8 units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
14.4 units on a scale
STANDARD_DEVIATION 1.7 • n=7 Participants
|
14.0 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Gait stride length (cm)
|
69.8 cms
STANDARD_DEVIATION 30.4 • n=5 Participants
|
82.2 cms
STANDARD_DEVIATION 27.3 • n=7 Participants
|
75.1 cms
STANDARD_DEVIATION 29.1 • n=5 Participants
|
|
motor Unified Parkinson's Disease Rating Scale (UPDRS) score
|
37.7 units on a scale
STANDARD_DEVIATION 5.9 • n=5 Participants
|
38.0 units on a scale
STANDARD_DEVIATION 8.3 • n=7 Participants
|
37.8 units on a scale
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Parkinson's Disease Questionnaire-39 (PDQ-39)
|
59.8 units on a scale
STANDARD_DEVIATION 21.1 • n=5 Participants
|
60.7 units on a scale
STANDARD_DEVIATION 21.3 • n=7 Participants
|
60.1 units on a scale
STANDARD_DEVIATION 20.7 • n=5 Participants
|
|
REM sleep Behavior Disorder Questionnaire (RBD-Q)
|
5.1 units on a scale
STANDARD_DEVIATION 3.5 • n=5 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 2.9 • n=7 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Epworth Sleepiness Scale (ESS) score
|
10.3 units on a scale
STANDARD_DEVIATION 2.9 • n=5 Participants
|
10.1 units on a scale
STANDARD_DEVIATION 4.6 • n=7 Participants
|
10.2 units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Participants that completed the placebo controlled portion of the study (first 12 weeks of the study)
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.
Outcome measures
| Measure |
Delayed-start
n=7 Participants
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
|
Early-start
n=12 Participants
24 weeks of modafinil 50 mg oral daily
modafinil 50mg: 1 capsule oral daily
|
|---|---|---|
|
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).
12 weeks
|
13.43 units on a scale
Standard Deviation 1.90
|
14.42 units on a scale
Standard Deviation 4.03
|
|
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).
0 weeks (Baseline)
|
14.57 units on a scale
Standard Deviation 1.62
|
13.75 units on a scale
Standard Deviation 2.53
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Participants that completed the placebo controlled portion of the study (first 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.
Outcome measures
| Measure |
Delayed-start
n=7 Participants
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
|
Early-start
n=12 Participants
24 weeks of modafinil 50 mg oral daily
modafinil 50mg: 1 capsule oral daily
|
|---|---|---|
|
Mean Change From Baseline Stride Length After 12 Weeks on Treatment, as Measured Using an Instrumented Gait Mat.
0 weeks (baseline)
|
90.13 cms
Standard Deviation 14.53
|
69.78 cms
Standard Deviation 30.37
|
|
Mean Change From Baseline Stride Length After 12 Weeks on Treatment, as Measured Using an Instrumented Gait Mat.
12 weeks
|
88.97 cms
Standard Deviation 15.91
|
64.04 cms
Standard Deviation 33.55
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Subjects who completed the first 12 weeks of the study
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.
Outcome measures
| Measure |
Delayed-start
n=7 Participants
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
|
Early-start
n=12 Participants
24 weeks of modafinil 50 mg oral daily
modafinil 50mg: 1 capsule oral daily
|
|---|---|---|
|
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).
0 weeks (baseline)
|
39.00 units on a scale
Standard Deviation 9.11
|
37.71 units on a scale
Standard Deviation 5.95
|
|
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
|
34.36 units on a scale
Standard Deviation 9.07
|
37.25 units on a scale
Standard Deviation 10.02
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants that completed the placebo controlled portion of the study (first 12 weeks)
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.
Outcome measures
| Measure |
Delayed-start
n=7 Participants
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
|
Early-start
n=12 Participants
24 weeks of modafinil 50 mg oral daily
modafinil 50mg: 1 capsule oral daily
|
|---|---|---|
|
Mean Change From Baseline Quality of Life After 12 Weeks on Treatment, as Measured by the Parkinson's Disease Questionnaire-39 (PDQ-39).
0 weeks (baseline)
|
65.7 units on a scale
Standard Deviation 21.2
|
59.8 units on a scale
Standard Deviation 21.1
|
|
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
|
63.3 units on a scale
Standard Deviation 23.5
|
62.6 units on a scale
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: 12 weeksFor 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.
Outcome measures
| Measure |
Delayed-start
n=7 Participants
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
|
Early-start
n=12 Participants
24 weeks of modafinil 50 mg oral daily
modafinil 50mg: 1 capsule oral daily
|
|---|---|---|
|
Mean Change From Baseline Sleep Quality After 12 Weeks on Treatment, as Measured by the REM Sleep Behavior Disorder Questionnaire (RBD-Q).
12 weeks
|
3.57 units on a scale
Standard Deviation 2.37
|
5.58 units on a scale
Standard Deviation 3.65
|
|
Mean Change From Baseline Sleep Quality After 12 Weeks on Treatment, as Measured by the REM Sleep Behavior Disorder Questionnaire (RBD-Q).
0 weeks (baseline)
|
5.42 units on a scale
Standard Deviation 2.37
|
5.08 units on a scale
Standard Deviation 3.53
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants that completed the placebo controlled portion of the study (first 12 weeks)
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.
Outcome measures
| Measure |
Delayed-start
n=7 Participants
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
|
Early-start
n=12 Participants
24 weeks of modafinil 50 mg oral daily
modafinil 50mg: 1 capsule oral daily
|
|---|---|---|
|
Mean Change From Baseline Sleep Quality After 12 Weeks on Treatment, as Measured by the Epworth Sleepiness Scale (ESS).
0 weeks (baseline)
|
9.00 units on a scale
Standard Deviation 4.58
|
10.33 units on a scale
Standard Deviation 2.90
|
|
Mean Change From Baseline Sleep Quality After 12 Weeks on Treatment, as Measured by the Epworth Sleepiness Scale (ESS).
12 weeks
|
8.71 units on a scale
Standard Deviation 2.69
|
10.25 units on a scale
Standard Deviation 4.35
|
Adverse Events
Early-start
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Delayed-start
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Early-start
n=12 participants at risk
24 weeks of modafinil 50 mg oral daily
modafinil 50mg: 1 capsule oral daily
|
Delayed-start
n=9 participants at risk
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
|
|---|---|---|
|
Nervous system disorders
Cervical stenosis
|
8.3%
1/12 • Number of events 1 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
Other adverse events
| Measure |
Early-start
n=12 participants at risk
24 weeks of modafinil 50 mg oral daily
modafinil 50mg: 1 capsule oral daily
|
Delayed-start
n=9 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
lower extremity edema
|
0.00%
0/12 • Period of the trial (30 weeks)
|
11.1%
1/9 • Period of the trial (30 weeks)
|
|
Cardiac disorders
dyspnea on exertion
|
0.00%
0/12 • Period of the trial (30 weeks)
|
11.1%
1/9 • Period of the trial (30 weeks)
|
|
Cardiac disorders
palpitations
|
0.00%
0/12 • Period of the trial (30 weeks)
|
11.1%
1/9 • Period of the trial (30 weeks)
|
|
Cardiac disorders
lightheadedness on standing
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Skin and subcutaneous tissue disorders
dry skin
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Skin and subcutaneous tissue disorders
facial rash
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Skin and subcutaneous tissue disorders
skin tag
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Endocrine disorders
cold intolerance
|
0.00%
0/12 • Period of the trial (30 weeks)
|
11.1%
1/9 • Period of the trial (30 weeks)
|
|
Endocrine disorders
diagnosed with diabetes
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
General disorders
rhinorrhea
|
16.7%
2/12 • Period of the trial (30 weeks)
|
22.2%
2/9 • Period of the trial (30 weeks)
|
|
General disorders
allergy flare
|
0.00%
0/12 • Period of the trial (30 weeks)
|
11.1%
1/9 • Period of the trial (30 weeks)
|
|
Eye disorders
lower eyelid edema
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Ear and labyrinth disorders
tinnitus
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/12 • Period of the trial (30 weeks)
|
11.1%
1/9 • Period of the trial (30 weeks)
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/12 • Period of the trial (30 weeks)
|
11.1%
1/9 • Period of the trial (30 weeks)
|
|
Metabolism and nutrition disorders
hyperphagia
|
0.00%
0/12 • Period of the trial (30 weeks)
|
11.1%
1/9 • Period of the trial (30 weeks)
|
|
Gastrointestinal disorders
nausea
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Musculoskeletal and connective tissue disorders
calf pain/cramps
|
16.7%
2/12 • Period of the trial (30 weeks)
|
22.2%
2/9 • Period of the trial (30 weeks)
|
|
Musculoskeletal and connective tissue disorders
bursitis/epicondylitis
|
0.00%
0/12 • Period of the trial (30 weeks)
|
11.1%
1/9 • Period of the trial (30 weeks)
|
|
Musculoskeletal and connective tissue disorders
neck stiffness
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Nervous system disorders
paresthesias
|
8.3%
1/12 • Period of the trial (30 weeks)
|
11.1%
1/9 • Period of the trial (30 weeks)
|
|
Nervous system disorders
morning grogginess
|
0.00%
0/12 • Period of the trial (30 weeks)
|
11.1%
1/9 • Period of the trial (30 weeks)
|
|
Nervous system disorders
daytime sleepiness
|
8.3%
1/12 • Period of the trial (30 weeks)
|
11.1%
1/9 • Period of the trial (30 weeks)
|
|
Nervous system disorders
insomnia
|
8.3%
1/12 • Period of the trial (30 weeks)
|
33.3%
3/9 • Period of the trial (30 weeks)
|
|
Nervous system disorders
falls
|
8.3%
1/12 • Period of the trial (30 weeks)
|
22.2%
2/9 • Period of the trial (30 weeks)
|
|
Nervous system disorders
sciatica
|
0.00%
0/12 • Period of the trial (30 weeks)
|
11.1%
1/9 • Period of the trial (30 weeks)
|
|
Nervous system disorders
daytime confusion
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Nervous system disorders
dysphagia
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Nervous system disorders
fatigue
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Nervous system disorders
hallucinations
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Nervous system disorders
hand cramps
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Nervous system disorders
freezing of gait
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Nervous system disorders
headaches
|
16.7%
2/12 • Period of the trial (30 weeks)
|
11.1%
1/9 • Period of the trial (30 weeks)
|
|
Nervous system disorders
imbalance
|
16.7%
2/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Nervous system disorders
difficulty getting out of bed
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Nervous system disorders
difficulty with ADLs
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Nervous system disorders
slowed gait
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Nervous system disorders
toe walking
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Nervous system disorders
word finding difficulty
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Eye disorders
lacrimation
|
8.3%
1/12 • Period of the trial (30 weeks)
|
11.1%
1/9 • Period of the trial (30 weeks)
|
|
Eye disorders
visual floaters/flashing
|
8.3%
1/12 • Period of the trial (30 weeks)
|
11.1%
1/9 • Period of the trial (30 weeks)
|
|
Eye disorders
blurred vision
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Psychiatric disorders
anxiety
|
8.3%
1/12 • Period of the trial (30 weeks)
|
22.2%
2/9 • Period of the trial (30 weeks)
|
|
Psychiatric disorders
depressed mood
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Psychiatric disorders
irritability
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Renal and urinary disorders
nocturia
|
33.3%
4/12 • Period of the trial (30 weeks)
|
11.1%
1/9 • Period of the trial (30 weeks)
|
|
Renal and urinary disorders
nephrolithiasis
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Renal and urinary disorders
urinary incontinance
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
|
Infections and infestations
urinary tract infection
|
8.3%
1/12 • Period of the trial (30 weeks)
|
0.00%
0/9 • Period of the trial (30 weeks)
|
Additional Information
Dr. Tuhin Virmani
University of Arkansas for Medical Sciences
Phone: 501-686-7235
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place