Sporadic Amyotrophic Lateral SclerosisPhase 2Mexiletine-2NCT02781454
Mexiletine in Sporadic Amyotrophic Lateral Sclerosis
A Phase 2 study testing Mexiletine in people with Sporadic Amyotrophic Lateral Sclerosis, run by University of Washington at 10 sites in United States.
Trial summary
The purpose of this research study is to find out whether the drug mexiletine will be effective in lowering motor neuron electrical activity in the brains and nerves in the arms of people with ALS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sporadic Amyotrophic Lateral Sclerosis
- What is being tested?
- Mexiletine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2016to 30 Sep 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sporadic ALS diagnosed as possible, laboratory-supported probable, probable, or definite ALS as defined by revised El Escorial criteria.
- Age 18 years or older.
- Symptom onset of weakness or spasticity due to ALS ≤ 60 months prior to Screening Visit.
- Slow vital capacity (SVC) measure ≥50% of predicted for gender, height, and age at the screening visit.
- Must be able to swallow capsules throughout the course of the study, according to Site Investigator judgment.
- Capable of providing informed consent and following trial procedures.
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- For TMS: a resting motor threshold defined as 50% of pulses eliciting a motor evoked potential (MEP) of amplitude ≥ 50 µV.
- For TTNCS: median Compound Muscle Action Potential (CMAP) ≥ 1.5 mV.
- Subjects must not have taken riluzole for at least 30 days or be on a stable dose of riluzole for at least 30 days prior to the Screening Visit and continue on the stable dose throughout the course of the study (riluzole-naïve subjects are permitted in the study).
- Subjects must not have taken medication for muscle cramping such as cyclobenzaprine, baclofen, carisoprodol, or methocarbamol, for at least 30 days prior to screening or be on a stable dose for at least 60 days prior to screening.
- Geographic accessibility to the site.
- Women must not become pregnant for the duration of the study and must be willing to use two contraceptive therapies and have a negative pregnancy test throughout the course of the study.
- Use of medications known to affect the neurophysiology measures in the study must be scheduled, not as needed (pro re nata, PRN). A subject must have been on a fixed dose for 30 days prior to the Screening Visit, and there must be no reason to believe that a subsequent change would be necessary during the course of the study. These medications include: benzodiazepines, muscle relaxants, tricyclic antidepressants, selective serotonin reuptake inhibitors, non-selective serotonin reuptake inhibitors, hypnotics (including anti-histamines) and anti-cholinergics.
Who cannot join
- Invasive ventilator dependence, such as tracheostomy.
- Creatinine level greater than 1.5 mg/dL at screening.
- Serum Glutamic-Oxaloacetic (SGOT/AST) / Serum Glutamic-Pyruvic (SGPT/ALT) greater than 3 times the upper limit of normal at screening.
- History of known sensitivity or intolerability to mexiletine or lidocaine.
- Any history of either substance abuse within the past year, unstable psychiatric disease, cognitive impairment, or dementia.
- Clinically significant conduction abnormalities on electrocardiogram or a known history of cardiac arrhythmia.
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- Known history of epilepsy.
- Known history of congestive heart failure (CHF) or history of myocardial infarction within the past 24 months.
- Use of mexiletine for 30 days prior to Screening Visit.
- Exposure to any other experimental agent (off-label use or investigational) including high dose creatine (>10 grams a day) within 30 days prior to Screening Visit.
- Metal in the head and neck region, cardiac pacemaker or brain stimulator, cochlear implants, implanted infusion device or personal history of epilepsy.
- Use of amiodarone, flecainide, duloxetine, tizanidine, or clozapine.
- Pregnant women or women currently breastfeeding.
- Placement of Diaphragm Pacing System (DPS) device < 60 days prior to Screening Visit.
- Planned DPS device implantation during study participation
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Michigan
Ann Arbor, Michigan, 48109
Augusta University
Augusta, Georgia, 30912
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425
Pennsylvania State Hershey Medical Center
Hershey, Pennsylvania, 17033
Columbia Universtiy Medical Center
New York, New York, 10032
University of California, Irvine
Orange, California, 92868
Barrow Neurological Institute
Phoenix, Arizona, 85013
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Washington
Seattle, Washington, 98195
About this study
Official title: Effect of Mexiletine on Cortical Hyperexcitability in Sporadic Amyotrophic Lateral Sclerosis (SALS)
The purpose of this research study is to find out whether the drug mexiletine will be effective in lowering motor neuron electrical activity in the brains and nerves in the arms of people with ALS. The investigators will also determine if there are any signs that the drug may slow down the progression of ALS and reduce muscle cramps and muscle twitching. This will be determined through transcranial magnetic stimulation (TMS) and threshold tracking nerve conduction studies (TTNCS). In this trial, the participants will be taking either 300mg/day of mexiletine, 600mg/day of mexiletine, or placebo (non-active study drug).
Read the detailed description
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disorder affecting primarily motor neurons, for which treatment designed to slow or arrest progression remains lacking. Mexiletine is a use-dependent sodium channel blocker that has been FDA-approved for decades for the treatment of cardiac arrhythmias and more recently to treat neuropathic pain in diabetic polyneuropathy. Mexiletine has been shown also to be protective of neurons following spinal cord, head injury, and cerebral ischemia, largely by blocking excitotoxicity. Based on previous studies, mexiletine appears to penetrate into the central nervous system at concentrations sufficient to confer significant protection. Recent unpublished studies in the laboratory of Dr. Robert Brown at the University of Massachusetts have also demonstrated that mexiletine ingestion in mice genetically engineered to express high levels of mutant cytosolic copper-zinc superoxide dismutase-1 (SOD1) transgene prolongs survival in these animals. As mexiletine already has FDA-approval as an anti-arrhythmic agent, much is known about the pharmacology and safety of this drug in non-ALS patients. We anticipate that by excluding subjects with a known history of cardiac disease and with the known neuroprotectant properties of this medication, mexiletine is a good choice for further study in an ALS clinical trial.
- Conditions
- Sporadic Amyotrophic Lateral Sclerosis
- Being tested
- Mexiletine, Placebo
- Keywords
- SALS, Mexiletine, TMS, NCS
- Medical subject headings
- Amyotrophic lateral sclerosis 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MexiletineDrug
Also called Mexitil
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Mexiletine, 300 milligrams | Active comparator | Mexiletine, 300 milligrams by mouth per day for 4 weeks. Receives: Drug: Mexiletine |
| Mexiletine, 600 milligrams | Active comparator | Mexiletine, 600 milligrams by mouth per day for 4 weeks. Receives: Drug: Mexiletine |
| Placebo | Placebo comparator | Placebo, by mouth per day for 4 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Resting Motor Threshold
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.
Measured: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 and from Week 4 to Week 8 reported
Secondary outcomes (10)
Effect on Short-interval Intracortical Inhibition
Short-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.
Measured: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported
Change in Motor Evoked Potential Amplitude
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.
Measured: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported
Effect on Cortical Silent Period
The 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.
Measured: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported
Effect on 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.
Measured: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported
Effect on Depolarizing Threshold Electrotonus (90-100 ms)
Depolarizing 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.
Measured: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported
Effect on Hyperpolarizing Threshold Electrotonus (90-100 ms)
Hyperpolarizing 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.
Measured: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported
Effect on Superexcitability
Superexcitability 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.
Measured: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported
Effect on Subexcitability
Subexcitability 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.
Measured: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported
Effect on Frequency of Muscle Cramps
Will be assessed using a daily muscle cramps diary tabulated weekly beginning at Baseline.
Measured: Accessed at Screening, Baseline, Week 4, and Week 8; comparisons of treatments at Weeks 3-4 reported
Effect on Frequency of Fasciculations (Muscle Twitching)
Will be assessed using a daily fasciculations diary tabulated as a percentage of days from weeks 3-4.
Measured: Accessed at Screening, Baseline, Week 4, and Week 8; comparisons of treatments at Weeks 3-4 reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startOct 2016
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
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 Sporadic Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Michael D Weiss, University of Washington
- Investigators
- Michael Weiss, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781454
- Sponsor's protocol ID
- MX-ALS-002
- Acronym
- Mexiletine-2
- Status last verified
- Nov 2019
- First submitted
- 10 May 2016
- Last updated
- 5 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mexiletine on Cortical Hyperexcitability in Sporadic Amyotrophic Lateral Sclerosis (SALS)
- ClinicalTrials.gov ID
- NCT02781454
- Acronym / sponsor ID
- Mexiletine-2 / MX-ALS-002
- Conditions
- Sporadic Amyotrophic Lateral Sclerosis
- Keywords
- SALS, Mexiletine, TMS, NCS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- Oct 2016 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 24 May 2016 (estimated)
- Results
- Posted 5 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to find out whether the drug mexiletine will be effective in lowering motor neuron electrical activity in the brains and nerves in the arms of people with ALS. The investigators will also determine if there are any signs that the drug may slow down the progression of ALS and reduce muscle cramps and muscle twitching. This will be determined through transcranial magnetic stimulation (TMS) and threshold tracking nerve conduction studies (TTNCS). In this trial, the participants will be taking either 300mg/day of mexiletine, 600mg/day of mexiletine, or placebo (non-active study drug).
Detailed description
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disorder affecting primarily motor neurons, for which treatment designed to slow or arrest progression remains lacking. Mexiletine is a use-dependent sodium channel blocker that has been FDA-approved for decades for the treatment of cardiac arrhythmias and more recently to treat neuropathic pain in diabetic polyneuropathy. Mexiletine has been shown also to be protective of neurons following spinal cord, head injury, and cerebral ischemia, largely by blocking excitotoxicity. Based on previous studies, mexiletine appears to penetrate into the central nervous system at concentrations sufficient to confer significant protection. Recent unpublished studies in the laboratory of Dr. Robert Brown at the University of Massachusetts have also demonstrated that mexiletine ingestion in mice genetically engineered to express high levels of mutant cytosolic copper-zinc superoxide dismutase-1 (SOD1) transgene prolongs survival in these animals. As mexiletine already has FDA-approval as an anti-arrhythmic agent, much is known about the pharmacology and safety of this drug in non-ALS patients. We anticipate that by excluding subjects with a known history of cardiac disease and with the known neuroprotectant properties of this medication, mexiletine is a good choice for further study in an ALS clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mexiletine, 300 milligrams | Active comparator | Drug: MexiletineMexiletine, 300 milligrams by mouth per day for 4 weeks. |
| Mexiletine, 600 milligrams | Active comparator | Drug: MexiletineMexiletine, 600 milligrams by mouth per day for 4 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, by mouth per day for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Sporadic ALS diagnosed as possible, laboratory-supported probable, probable, or definite ALS as defined by revised El Escorial criteria.
- Age 18 years or older.
- Symptom onset of weakness or spasticity due to ALS ≤ 60 months prior to Screening Visit.
- Slow vital capacity (SVC) measure ≥50% of predicted for gender, height, and age at the screening visit.
- Must be able to swallow capsules throughout the course of the study, according to Site Investigator judgment.
Key exclusion criteria (15 listed)
- Invasive ventilator dependence, such as tracheostomy.
- Creatinine level greater than 1.5 mg/dL at screening.
- Serum Glutamic-Oxaloacetic (SGOT/AST) / Serum Glutamic-Pyruvic (SGPT/ALT) greater than 3 times the upper limit of normal at screening.
- History of known sensitivity or intolerability to mexiletine or lidocaine.
- Any history of either substance abuse within the past year, unstable psychiatric disease, cognitive impairment, or dementia.
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 |
|---|---|---|
| MexiletineAlso: Mexitil | Drug | Mexiletine, 300 milligrams, Mexiletine, 600 milligrams |
| Placebo | Drug | Placebo |
Primary outcome
Change in Resting Motor Threshold
Time frame: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 and from Week 4 to Week 8 reported
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.
10 secondary outcomes
Effect on Short-interval Intracortical Inhibition
Time frame: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported
Change in Motor Evoked Potential Amplitude
Time frame: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported
Effect on Cortical Silent Period
Time frame: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported
Effect on Strength Duration Time Constant
Time frame: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported
Effect on Depolarizing Threshold Electrotonus (90-100 ms)
Time frame: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported
Effect on Hyperpolarizing Threshold Electrotonus (90-100 ms)
Time frame: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported
Effect on Superexcitability
Time frame: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported
Effect on Subexcitability
Time frame: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported
Effect on Frequency of Muscle Cramps
Time frame: Accessed at Screening, Baseline, Week 4, and Week 8; comparisons of treatments at Weeks 3-4 reported
Effect on Frequency of Fasciculations (Muscle Twitching)
Time frame: Accessed at Screening, Baseline, Week 4, and Week 8; comparisons of treatments at Weeks 3-4 reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Northeast ALS Consortium WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Michael Weiss, MD principal investigator
University of Washington
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mexiletine in people with Sporadic Amyotrophic Lateral Sclerosis, run by University of Washington at 10 sites 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 13 inclusion and 15 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 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 5 Dec 2019). 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?
Change in Resting Motor Threshold (time frame: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 and from Week 4 to Week 8 reported). 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 5 Dec 2019.