Trial Outcomes & Findings for Mexiletine in Sporadic Amyotrophic Lateral Sclerosis (NCT NCT02781454)
NCT ID: NCT02781454
Last Updated: 2019-12-05
Results Overview
The resting motor threshold (RMT) assessed from single pulse transcranial magnetic stimulation (TMS) measurements made before treatment, after 4 weeks of treatment, and then again after a 4 week washout, was used as the primary pharmacodynamic marker of cortical hyperexcitability. RMT is the stimulus intensity required to produce and maintain a 0.2 mV peak-to-peak motor evoked potential of the abductor pollicis brevis muscle by TMS. A smaller RMT is thought to suggest greater neuronal excitability.
COMPLETED
PHASE2
20 participants
Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 and from Week 4 to Week 8 reported
2019-12-05
Participant Flow
Subjects were enrolled at 9 Northeast ALS Consortium (NEALS) centers in the US. These NEALS centers were academic clinical research centers with established practices where sporadic ALS (sALS) patients are regularly seen and treated.
Within 21 days prior to treatment assignment, patients were screened for eligibility based on inclusion/exclusion criteria. Failure to meet any of these criteria at the time of this screening would result in exclusion from the study, and these patients would not be assigned to a treatment group.
Participant milestones
| Measure |
Mexiletine, 300 Milligrams
Mexiletine, 300 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Mexiletine, 600 Milligrams
Mexiletine, 600 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Placebo
Placebo, by mouth per day for 4 weeks.
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
6
|
|
Overall Study
COMPLETED
|
8
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mexiletine in Sporadic Amyotrophic Lateral Sclerosis
Baseline characteristics by cohort
| Measure |
Mexiletine, 300 Milligrams
n=8 Participants
Mexiletine, 300 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Mexiletine, 600 Milligrams
n=6 Participants
Mexiletine, 600 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Placebo
n=6 Participants
Placebo, by mouth per day for 4 weeks.
Placebo
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 14.1 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
El Escorial Diagnosis
Possible
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
El Escorial Diagnosis
Prob Lab Supported
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
El Escorial Diagnosis
Probable
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
El Escorial Diagnosis
Definite
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 and from Week 4 to Week 8 reportedThe resting motor threshold (RMT) assessed from single pulse transcranial magnetic stimulation (TMS) measurements made before treatment, after 4 weeks of treatment, and then again after a 4 week washout, was used as the primary pharmacodynamic marker of cortical hyperexcitability. RMT is the stimulus intensity required to produce and maintain a 0.2 mV peak-to-peak motor evoked potential of the abductor pollicis brevis muscle by TMS. A smaller RMT is thought to suggest greater neuronal excitability.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=8 Participants
Mexiletine, 300 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Mexiletine, 600 Milligrams
n=6 Participants
Mexiletine, 600 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Placebo
n=6 Participants
Placebo, by mouth per day for 4 weeks.
Placebo
|
|---|---|---|---|
|
Change in Resting Motor Threshold
change from baseline to week 4
|
-2.430 percentage of maximum stimulus output
Standard Error 2.323
|
0.805 percentage of maximum stimulus output
Standard Error 2.207
|
4.746 percentage of maximum stimulus output
Standard Error 2.185
|
|
Change in Resting Motor Threshold
change from week 4 to week 8
|
1.465 percentage of maximum stimulus output
Standard Error 2.357
|
-0.284 percentage of maximum stimulus output
Standard Error 2.169
|
-2.908 percentage of maximum stimulus output
Standard Error 2.247
|
SECONDARY outcome
Timeframe: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reportedShort-interval intracortical inhibition (SICI) is a measure of neuronal excitability measured by dual pulse TMS with a conditioned (80% of RMT) and test pulses (120% of RMT) to generate a stable MEP amplitude of 0.2 mV, averaged over interstimulus intervals of 1-7 ms. It is thought to reflect refractory cortical axons and subsequent resynchronization of cortico-cortical and corticomotoneuronal volleys or activation of non-GABAergic cortical inhibitory circuits (initial phase) and synaptic neurotransmission through GABAA receptors (second phase). The value for SICI thought to be maximally sensitive for detecting in changes in ALS subjects compared to controls is is derived by measuring the motor evoked potential amplitude (MEP) at an interstimulus interval of 3 ms (ISI 3 ms) and normalizing to the MEP amplitude at 120% of the resting motor threshold (MEP 120% RMT). A reduction in SICI reflecting greater excitability would generate a larger ratio of MEP ISI 3 ms/MEP 120% RMT.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=8 Participants
Mexiletine, 300 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Mexiletine, 600 Milligrams
n=6 Participants
Mexiletine, 600 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Placebo
n=6 Participants
Placebo, by mouth per day for 4 weeks.
Placebo
|
|---|---|---|---|
|
Effect on Short-interval Intracortical Inhibition
|
0.655 unitless ratio MEP ISI 3 ms/MEP 120% RMT
Interval 0.437 to 0.983
|
0.886 unitless ratio MEP ISI 3 ms/MEP 120% RMT
Interval 0.608 to 1.291
|
0.961 unitless ratio MEP ISI 3 ms/MEP 120% RMT
Interval 0.634 to 1.459
|
SECONDARY outcome
Timeframe: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reportedPopulation: MEP at 120% RMT/peak CMAP
The motor evoked potential (MEP) amplitude is taken from single pulse transcranial magnetic stimulation (TMS) and reflects the density of corticomotoneuronal projections onto motor neurons and is affected by cortical hyperexcitability early in ALS where it is thought to be larger than age-matched controls and axonal degeneration later in the disease when it decreases in amplitude. The MEP is most reliable in assessing cortical motor neuronal preservation and excitability when normalized to the peak compound nerve action potential (CMAP) amplitude which reflects the integrity of peripheral motor nerve axons. It is also normalized here to 120% of the RMT to derive a ratio of MEP at 120% RMT/peak CMAP.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=8 Participants
Mexiletine, 300 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Mexiletine, 600 Milligrams
n=6 Participants
Mexiletine, 600 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Placebo
n=6 Participants
Placebo, by mouth per day for 4 weeks.
Placebo
|
|---|---|---|---|
|
Change in Motor Evoked Potential Amplitude
|
0.589 unitless ratio of ms/ms
Interval 0.315 to 1.102
|
0.490 unitless ratio of ms/ms
Interval 0.249 to 0.965
|
1.308 unitless ratio of ms/ms
Interval 0.695 to 2.462
|
SECONDARY outcome
Timeframe: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reportedThe cortical silent period (CSP) is recorded with single pulse TMS as a duration from the onset of the MEP response to resumption of voluntary electromyography activity with the patient performing a voluntary contraction, set to 30% of maximal voluntary contraction. A shorter CSP compared to controls would reflect greater excitability.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=8 Participants
Mexiletine, 300 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Mexiletine, 600 Milligrams
n=6 Participants
Mexiletine, 600 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Placebo
n=6 Participants
Placebo, by mouth per day for 4 weeks.
Placebo
|
|---|---|---|---|
|
Effect on Cortical Silent Period
|
3.937 milliseconds
Interval -31.75 to 39.624
|
4.823 milliseconds
Interval -29.76 to 39.408
|
4.037 milliseconds
Interval -30.84 to 38.911
|
SECONDARY outcome
Timeframe: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reportedPopulation: strength duration time constant
The strength duration time constant (SDTC) is used in threshold tracking nerve axonal excitability studies and is interpreted as a measure of axonal excitability that is dependent upon the biophysical properties of the axonal membrane at the node of Ranvier, especially persistent sodium current. It is derived from the relationship between stimulus duration and intensity. A higher SDTC would reflect greater excitability of motor nerve axons.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=8 Participants
Mexiletine, 300 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Mexiletine, 600 Milligrams
n=6 Participants
Mexiletine, 600 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Placebo
n=6 Participants
Placebo, by mouth per day for 4 weeks.
Placebo
|
|---|---|---|---|
|
Effect on Strength Duration Time Constant
|
0.895 milliseconds
Interval 0.802 to 0.998
|
0.966 milliseconds
Interval 0.848 to 1.099
|
0.935 milliseconds
Interval 0.837 to 1.045
|
SECONDARY outcome
Timeframe: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reportedDepolarizing threshold electrotonus (90-100 ms) (TEd 90-100 ms) is used in threshold tracking nerve axonal excitability studies in which long-lasting subthreshold depolarizing currents are generated, measured at 90-100 ms following the stimulus. This measure is associated with a decrease in the membrane excitability threshold due to opening of potassium channels on the axonal membrane. Intrinsic changes in axonal excitability properties, such as thought to occur in ALS, could possibly alter this measure, presumably by decreasing TEd 90-100 ms more substantially than normal.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=8 Participants
Mexiletine, 300 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Mexiletine, 600 Milligrams
n=6 Participants
Mexiletine, 600 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Placebo
n=6 Participants
Placebo, by mouth per day for 4 weeks.
Placebo
|
|---|---|---|---|
|
Effect on Depolarizing Threshold Electrotonus (90-100 ms)
|
-0.140 percentage of threshold depolarization
Interval -4.925 to 4.645
|
4.005 percentage of threshold depolarization
Interval -1.375 to 9.384
|
0.844 percentage of threshold depolarization
Interval -3.735 to 5.423
|
SECONDARY outcome
Timeframe: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reportedHyperpolarizing threshold electrotonus (90-100 ms) (TEh 90-100 ms) is used in threshold tracking nerve axonal excitability studies in which long-lasting subthreshold hyperpolarizing currents are generated, measured at 90-100 ms following the stimulus. This measure is associated with an increase in the membrane excitability threshold due to closure of potassium channels causing increased resistance of the internodal axonal membrane. Intrinsic changes in axonal excitability properties, such as thought to occur in ALS, could possibly alter this measure.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=8 Participants
Mexiletine, 300 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Mexiletine, 600 Milligrams
n=6 Participants
Mexiletine, 600 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Placebo
n=6 Participants
Placebo, by mouth per day for 4 weeks.
Placebo
|
|---|---|---|---|
|
Effect on Hyperpolarizing Threshold Electrotonus (90-100 ms)
|
-10.184 percentage threshold hyperpolarization
Interval -21.57 to 1.204
|
2.230 percentage threshold hyperpolarization
Interval -10.52 to 14.979
|
-4.219 percentage threshold hyperpolarization
Interval -15.0 to 6.562
|
SECONDARY outcome
Timeframe: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reportedSuperexcitability is a component of recovery cycle analysis assessing motor axonal excitability, employing threshold tracking nerve conduction study. It is a depolarizing afterpotential measured following a single supramaximal stimulus followed by a second smaller stimulus of variable intensity and reflects passive depolarization of the internodal axon.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=8 Participants
Mexiletine, 300 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Mexiletine, 600 Milligrams
n=6 Participants
Mexiletine, 600 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Placebo
n=6 Participants
Placebo, by mouth per day for 4 weeks.
Placebo
|
|---|---|---|---|
|
Effect on Superexcitability
|
2.234 percentage of threshold change
Interval -2.129 to 6.597
|
1.511 percentage of threshold change
Interval -3.391 to 6.413
|
-0.724 percentage of threshold change
Interval -4.974 to 3.526
|
SECONDARY outcome
Timeframe: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reportedSubexcitability is a component of recovery cycle analysis assessing motor axonal excitability, employing threshold tracking nerve conduction study. It is a late hyperpolarizing after potential measured following a single supramaximal stimulus followed by a second smaller stimulus of variable intensity and is related to the very slow turn-off of slow potassium channels.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=8 Participants
Mexiletine, 300 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Mexiletine, 600 Milligrams
n=6 Participants
Mexiletine, 600 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Placebo
n=6 Participants
Placebo, by mouth per day for 4 weeks.
Placebo
|
|---|---|---|---|
|
Effect on Subexcitability
|
-2.563 percentage of threshold change
Interval -5.706 to 0.581
|
-0.575 percentage of threshold change
Interval -4.178 to 3.027
|
0.448 percentage of threshold change
Interval -3.001 to 3.897
|
SECONDARY outcome
Timeframe: Accessed at Screening, Baseline, Week 4, and Week 8; comparisons of treatments at Weeks 3-4 reportedWill be assessed using a daily muscle cramps diary tabulated weekly beginning at Baseline.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=8 Participants
Mexiletine, 300 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Mexiletine, 600 Milligrams
n=6 Participants
Mexiletine, 600 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Placebo
n=6 Participants
Placebo, by mouth per day for 4 weeks.
Placebo
|
|---|---|---|---|
|
Effect on Frequency of Muscle Cramps
|
3.430 muscle cramps/week
Interval 1.152 to 10.21
|
1.987 muscle cramps/week
Interval 0.686 to 5.755
|
3.774 muscle cramps/week
Interval 0.687 to 20.74
|
SECONDARY outcome
Timeframe: Accessed at Screening, Baseline, Week 4, and Week 8; comparisons of treatments at Weeks 3-4 reportedWill be assessed using a daily fasciculations diary tabulated as a percentage of days from weeks 3-4.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=8 Participants
Mexiletine, 300 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Mexiletine, 600 Milligrams
n=6 Participants
Mexiletine, 600 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Placebo
n=6 Participants
Placebo, by mouth per day for 4 weeks.
Placebo
|
|---|---|---|---|
|
Effect on Frequency of Fasciculations (Muscle Twitching)
|
100 percentage of days with fasciculations
Interval 83.3 to 100.0
|
100 percentage of days with fasciculations
Interval 100.0 to 100.0
|
100 percentage of days with fasciculations
Interval 100.0 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reportedThe Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) is an instrument for evaluating the functional status of patients with ALS that includes functions related to speech, swallowing, salivation, fine motor control, gross motor function, and respiration. The score is the sum of 12 items (range 0 to 48) with higher scores reflecting better function.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=8 Participants
Mexiletine, 300 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Mexiletine, 600 Milligrams
n=6 Participants
Mexiletine, 600 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Placebo
n=6 Participants
Placebo, by mouth per day for 4 weeks.
Placebo
|
|---|---|---|---|
|
Change in the Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised
|
-1.414 score on a scale
Interval -2.554 to -0.274
|
-1.038 score on a scale
Interval -2.352 to 0.276
|
-0.827 score on a scale
Interval -2.141 to 0.487
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reportedMeasure of decline in respiratory muscle strength
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=8 Participants
Mexiletine, 300 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Mexiletine, 600 Milligrams
n=6 Participants
Mexiletine, 600 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Placebo
n=6 Participants
Placebo, by mouth per day for 4 weeks.
Placebo
|
|---|---|---|---|
|
Change in Slow Vital Capacity
|
-0.532 maximum percent predicted
Interval -4.425 to 3.361
|
-6.918 maximum percent predicted
Interval -11.37 to -2.461
|
-0.991 maximum percent predicted
Interval -5.45 to 3.467
|
Adverse Events
Mexiletine, 300 Milligrams
Mexiletine, 600 Milligrams
Placebo
Serious adverse events
| Measure |
Mexiletine, 300 Milligrams
n=8 participants at risk
Mexiletine, 300 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Mexiletine, 600 Milligrams
n=6 participants at risk
Mexiletine, 600 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Placebo
n=6 participants at risk
Placebo, by mouth per day for 4 weeks.
Placebo
|
|---|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/8 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
Other adverse events
| Measure |
Mexiletine, 300 Milligrams
n=8 participants at risk
Mexiletine, 300 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Mexiletine, 600 Milligrams
n=6 participants at risk
Mexiletine, 600 milligrams by mouth per day for 4 weeks.
Mexiletine
|
Placebo
n=6 participants at risk
Placebo, by mouth per day for 4 weeks.
Placebo
|
|---|---|---|---|
|
Ear and labyrinth disorders
Inner ear signs and symptoms
|
0.00%
0/8 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Gastrointestinal disorders
Dental pain and sensation disorders
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Gastrointestinal disorders
Diarrhoea (excl infective)
|
0.00%
0/8 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Gastrointestinal disorders
Dyspeptic signs and symptoms
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Gastrointestinal disorders
Gastrointestinal atonic and hypomotility disorders NEC
|
0.00%
0/8 • 8 weeks
|
33.3%
2/6 • Number of events 2 • 8 weeks
|
50.0%
3/6 • Number of events 3 • 8 weeks
|
|
Gastrointestinal disorders
Nausea and vomiting symptoms
|
0.00%
0/8 • 8 weeks
|
33.3%
2/6 • Number of events 2 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Oral dryness and saliva altered
|
0.00%
0/8 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Gastrointestinal disorders
Oral soft tissue pain and paraesthesia
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
General disorders
General signs and symptoms NEC
|
0.00%
0/8 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
General disorders
Implant and catheter site reactions
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
General disorders
Oedema NEC
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Infections and infestations
Lower respiratory tract and lung infections
|
0.00%
0/8 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Injury, poisoning and procedural complications
Non-site specific injuries NEC
|
0.00%
0/8 • 8 weeks
|
33.3%
2/6 • Number of events 2 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle pains
|
0.00%
0/8 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle related signs and symptoms NEC
|
12.5%
1/8 • Number of events 2 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue signs and symptoms NEC
|
0.00%
0/8 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Nervous system disorders
Headaches NEC
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
33.3%
2/6 • Number of events 2 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Nervous system disorders
Neurological signs and symptoms NEC
|
25.0%
2/8 • Number of events 2 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
|
Nervous system disorders
Speech and language abnormalities
|
0.00%
0/8 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Nervous system disorders
Tremor (excl congenital)
|
0.00%
0/8 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Psychiatric disorders
Disturbances in initiating and maintaining sleep
|
0.00%
0/8 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
|
Renal and urinary disorders
Bladder and urethral symptoms
|
0.00%
0/8 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Breathing abnormalities
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract signs and symptoms
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Erythemas
|
25.0%
2/8 • Number of events 5 • 8 weeks
|
16.7%
1/6 • Number of events 3 • 8 weeks
|
33.3%
2/6 • Number of events 8 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Rashes, eruptions and exanthems NEC
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Vascular disorders
Peripheral embolism and thrombosis
|
0.00%
0/8 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
General disorders
Asthenic
|
0.00%
0/8 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place