Nicotine AddictionPhase 2NCT01548638
Effect of Galantamine on Smoking Abstinence
A Phase 2 study testing Galantamine ER in people with Nicotine Addiction, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a preliminary open-label study to determine whether a medication called galantamine (Brand Name: Razadyne) will help smokers quit and whether it reduces cognitive problems that smokers experience during a quit attempt. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nicotine Addiction
- What is being tested?
- Galantamine ER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Oct 2013
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Smokers who are between 18 and 60 years of age who self-report smoking at least 10 cigarettes (menthol and non-menthol) per day for at least the last 6 months.
- Healthy as determined by the Study Physician, based on a medical evaluation including medical history and physical examination, and psychiatric evaluation.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and Health Insurance Portability and Accountability Act (HIPAA) form.
- Women of childbearing potential must consent to use a medically accepted method of birth control while participating in the study (e.g., condoms and spermicide, oral contraceptive, Depo-provera injection, contraceptive patch, tubal ligation).
Who cannot join
- Smoking Behavior
- Use of chewing tobacco, snuff, and/or snus.
- Current enrollment in a smoking cessation program, or use of other smoking cessation medications in the last month or plans to do either in the next 2 months.
- Provide a carbon monoxide (CO) breath sample reading less than 10ppm at Medical Screening or Baseline visit.
- Alcohol/Drugs
- Lifetime history of substance abuse (other than nicotine) and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, stimulants, Phencyclidine (PCP), benzodiazepines, or study prohibited medications/recreational drugs) as determined by self-report during the phone screen and/or through the MINI during the Medical Screening.
Show all 66Show fewer
- Current alcohol consumption that exceeds 25 standard drinks/week over the past 6 months.
- Providing a breath alcohol concentration (BrAC) reading of greater than or equal to 0.01 at Medical Screen or Baseline sessions.
- A positive urine drug screen for cocaine, amphetamines, methamphetamines, benzodiazepines, PCP, methadone, barbiturates, and opiates at the Medical Screening, Baseline visit, and Testing days.
- Medical
- Women who are pregnant, planning a pregnancy in the next 3 months, or lactating; all female subjects of child-bearing potential shall undergo a urine pregnancy test prior to enrollment and must agree in writing to use an approved method of contraception. Pregnancy tests will be conducted at the Medical Screening, Baseline visit, and Testing days.
- Diagnosis of Alzheimer's Disease or dementia.
- Current treatment of cancer or diagnosed with cancer (except basal cell carcinoma) in the past 6 months.
- Liver/kidney failure, peptic ulcer disease, benign prostate hypertrophy
- Asthma or chronic obstructive pulmonary disease (COPD)
- History (last 6 months) of abnormal heart rhythms, tachycardia and/or cardiovascular disease (stroke, angina, heart attack).
- Serious or unstable disease within the past 6 months, as determined by the Study Physician.
- Any impairment (physical and/or neurological) including visual or other impairment preventing cognitive task performance.
- Uncontrolled high blood pressure (systolic>150 or diastolic>90)
- Hearing impairment, significant hearing loss (more than 20% in either ear), cochlear implants, or bi-lateral hearing aids.
- History of brain injury.
- History of epilepsy or a seizure disorder.
- Color Blindness.
- Low or borderline intellectual functioning - determined by receiving a score of less than 90 on the Shipley Institute of Living Scale (SILS) which correlates with the Wechsler Adult Intelligence Scale-Revised (WAIS-R) Estimated Intelligence Quotient (IQ) Test (administered at Medical Screening).
- Psychiatric Exclusion (as determined by self-report on phone screen and/or through MINI during Medical Screening)
- Current diagnosis of major depression. Persons with a history of major depression, in remission for 6 months or longer, are eligible, provided they are not excluded based on medications (below).
- Suicide risk score on MINI greater than 0.
- History or current diagnosis of schizophrenia, psychosis, or bipolar disorder.
- Current or past hypomanic/manic episode.
- Current or history of a diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD).
- Medication
- Current use, recent discontinuation (within the last month) of any form of smoking cessation medications (i.e., Zyban, Wellbutrin, Wellbutrin sustained-release (SR), Chantix, nicotine replacement therapy).
- Current use, recent discontinuation (within the last 60 days) or planned use of the following medications:
- Anti-anxiety or panic disorder medications.
- Anti-psychotic medications.
- Mood-stabilizers (Lithium, Lamictal/lamotrigine, Neurontin/gabapentin, Topamax/topiramate, valproic acid, Tegretol/carbamazepine)
- Anti-depressants (e.g., Wellbutrin, monoamine oxidase inhibitor (MAOIs), selective serotonin reuptake inhibitor (SSRIs), tricyclic antidepressants).
- Prescription stimulants (e.g., Provigil, Ritalin, Adderall).
- Systemic Steroids (e.g., Prednisone).
- Current use (or use in the past 60 days) of:
- Alzheimer's disease medications (e.g., Acetylcholinesterase inhibitors (ACIs), Aricept/donepezil, Exelon/rivastigmine, Tacrine, or memantine).
- Parkinson's disease medications(e.g., Cogentin/benztropine).
- Irritable bowel syndrome medication (e.g., Dicylomine/Bentyl).
- Heart medications (e.g., quinidine or Procardia/nifedipine).
- Peptic ulcer disease medication (e.g, Zantac/ranitidine).
- Muscle relaxants (e.g., Soma/carisoprodol, Anectine/succinylcholine).
- Anti-fungal medication (e.g., Nizoral/ketoconazole).
- Anti-seizure medications (e.g., Ativan, Banzel, Carbatrol, Dilantin, Lamictal, Gabitril, Lyrica, Neurontin, Tegretol, Topamax).
- COPD medication (e.g., Atrovent/Ipratropium Bromide).
- Blood pressure medication (e.g., Inversine/Mecamylamine).
- Urinary retention medications (Duvoid/bethanechol, Proscar/finasteride, Avodart/dutasteride, Dibenzyline/phenoxybenzamine, Regitine/phentolamine).
- Eye medication (e.g., Atropine).
- Daily use of:
- Opiate-containing medications for chronic pain (Duragesic/fentanyl patches, Percocet, Oxycontin).
- Medication for asthma (albuterol, Serevent, Combivent, Advair, Flovent, Azmacort, Symbicort).
- Known allergy to study medication.
- Participants shall be instructed to refrain from using any study prohibited drugs (note - participants are allowed to take prescription medicines not in the exclusion list) throughout their participation in the study.
- General Exclusion
- Current enrollment or plans to enroll in another research program in the next 2 months.
- Any medical condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
- Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator.
- Completion of cognitive testing in studies in our center within the last 6 months.
- Able to effectively communicate in English (reading, writing, speaking).
- Missing 2 or more consecutive sessions, or 3 or more sessions during the medication period.
- Missing 2 or more consecutive doses during the medication period.
- Missing 3 or more doses throughout the medication period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Interdisciplinary Research on Nicotine Addiction, School of Medicine, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Effect of the Acetylcholinesterase Inhibitor, Galantamine, on Short-term Abstinence
This is a preliminary open-label study to determine whether a medication called galantamine (Brand Name: Razadyne) will help smokers quit and whether it reduces cognitive problems that smokers experience during a quit attempt.
Read the detailed description
Galantamine, an FDA-approved treatment for Alzheimer's disease, is used to treat cognitive impairment by enhancing acetylcholine through inhibition of the enzyme, acetylcholinesterase. We propose an open-label pilot feasibility study of short-term (6 weeks) treatment with galantamine.
Sixteen chronic smokers will undergo a validated procedure for screening new medications. Following an initial 4-week drug run-up phase (8mg daily of galantamine-ER), medication dose will be increased to 16 mg daily of galantamine-ER during the fifth and sixth weeks of the study. At the beginning of Week 6, smokers will receive brief counseling and make a 7-day quit attempt.
Following completion of the study, participants will be offered standard smoking cessation treatment. Subjects will perform a working memory task (Visual/Spatial N-Back), a sustained attention task (Continuous Performance Task; CPT), a recall memory task (Word Recognition), a cognitive flexibility task (Wisconsin Card Sort Test), and a response inhibition task (Stop Signal Task). The primary outcome is the ability to remain abstinent during a 7-day quit attempt. Secondary outcomes include change in cognitive performance, adherence, and side effects.
This pilot study will provide information about the role of the cholinergic system during brief abstinence and whether enhancing acetylcholine reduces abstinence-induced cognitive symptoms that promote smoking relapse. Information obtained in this study may further establish cognitive performance measures as endophenotypes for nicotine dependence.
- Conditions
- Nicotine Addiction
- Being tested
- Galantamine ER
- Keywords
- Tobacco, Smoking, Galantamine
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galantamine ERDrug
Also called Razadyne ER
The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER.
| Study group | Role | What they receive |
|---|---|---|
| Galantamine ER | Experimental | The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. Receives: Drug: Galantamine ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days of Abstinence During a 7-day Quit Attempt
Participants will undergo a 6-week study medication period. Day 36 will be the beginning of a 7-day practice quit attempt, during which number of days of abstinence will be assessed.
Measured: Days 36-43; following a 5-week dose run-up
Secondary outcomes (6)
Cognitive Performance: Working Memory Reaction Time
Participants will complete neurocognitive test designed to test working memory and attention and are similar to computer games, in that participants will push a button in response to the pictures they see. Working memory was measured using a computerized N-back task. During the N-back, participants are instructed to remember the location of a stimulus, a grey circle that is approximately 5 cm in diameter, as it appears randomly in 8 possible locations around the perimeter of a computer screen. Stimulus duration is 200 ms, followed by an interstimulus interval (ISI) of 2800 ms. The N-back task includes 4 conditions of varying difficulty levels: the 0-back, 1-back, 2-back, and 3-back.
Median reaction time to correct responses is described below.
Typical responses range from 250 ms to 1500 ms.
Measured: At Baseline (Day 0), Day 35 (Day before Target Quit Day), and Day 43
Cognitive Performance: Working Memory Accuracy
Participants will complete neurocognitive test designed to test working memory and attention and are similar to computer games, in that participants will push a button in response to the pictures they see. Working memory was measured using a computerized N-back task. During the N-back, participants are instructed to remember the location of a stimulus, a grey circle that is approximately 5 cm in diameter, as it appears randomly in 8 possible locations around the perimeter of a computer screen. Stimulus duration is 200 ms, followed by an interstimulus interval (ISI) of 2800 ms. The N-back task includes 4 conditions of varying difficulty levels: the 0-back, 1-back, 2-back, and 3-back.
Number of correct responses (true positives) is described below.
The maximum number of correct responses is 60.
Measured: At Baseline (Day 0), Day 35 (Day before Target Quit Day), and Day 43
Subjective Symptoms (Smoking Urges)
During each visit, we asked subjects to complete the Questionnaire for Smoking Urges-Brief (QSU-B). This measure is an index of urges to smoke, or cigarette craving. The subjective symptoms listed above will be assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt).
The range of possible scores on the QSU-B is 10-70, with higher values indicating increased urges to smoke. This range of scores represents a "total" score; there are no subscales.
Measured: Days 7, 14, 21, 28, 35, and 43; Baseline session
Side Effects of Galantamine
Side effects of galantamine were assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt). A 37-item checklist of side effects based on the product insert (e.g., Nausea, Vomiting, Diarrhea, Loss of appetite, Stomach pain, Constipation, Gastroesophageal Reflux Problems (Heartburn)) was administered to participants at all study visits after the Intake. An open-ended side effects question was also be included.
Items were measured on a scale from 0 (None) to 3 (Severe).
The side effect summary score (total side effects averaged from the 37 item checklist) at each visit is reported below. Each score ranges from 0 (None) to 3 (Severe).
Measured: Days 7, 14, 21, 28, 35, 37, 39, and 43; Baseline session
Subjective Symptoms (Negative Affect)
Subjects were asked to complete the Positive and Negative Affect Scale (PANAS) to assess symptoms of negative affect (the positive affect scale was not administered). This 10-item scale assesses was assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt).
The range of possible total scores on the PANAS negative affect scale is 10-50, with higher values indicating an increased nicotine withdrawal. This range of scores represent a "total" score; there are no subscales within the negative affect scale of the PANAS.
Measured: Days 7, 14, 21, 28, 35, and 43; Baseline session
Subjective Symptoms (Nicotine Withdrawal)
Subjects were asked to complete the Minnesota Nicotine Withdrawal Scale - Revised version (MNWS). The scale assesses eight DSM-IV items of nicotine withdrawal. The subjective symptoms listed above were assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt).
The range of possible total scores on the MNWS is 0-60, with higher values indicating an increased nicotine withdrawal. This range of scores represent a "total" score; there are no subscales.
Measured: Days 7, 14, 21, 28, 35, and 43; Baseline session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2012
- Study completionOct 2013
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 Nicotine AddictionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Ashare, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548638
- Sponsor's protocol ID
- 814947
- Status last verified
- Nov 2017
- First submitted
- 5 Mar 2012
- Last updated
- 26 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Acetylcholinesterase Inhibitor, Galantamine, on Short-term Abstinence
- ClinicalTrials.gov ID
- NCT01548638
- Acronym / sponsor ID
- 814947
- Conditions
- Nicotine Addiction
- Keywords
- Tobacco, Smoking, Galantamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Posted 2 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a preliminary open-label study to determine whether a medication called galantamine (Brand Name: Razadyne) will help smokers quit and whether it reduces cognitive problems that smokers experience during a quit attempt.
Detailed description
Galantamine, an FDA-approved treatment for Alzheimer's disease, is used to treat cognitive impairment by enhancing acetylcholine through inhibition of the enzyme, acetylcholinesterase. We propose an open-label pilot feasibility study of short-term (6 weeks) treatment with galantamine.
Sixteen chronic smokers will undergo a validated procedure for screening new medications. Following an initial 4-week drug run-up phase (8mg daily of galantamine-ER), medication dose will be increased to 16 mg daily of galantamine-ER during the fifth and sixth weeks of the study. At the beginning of Week 6, smokers will receive brief counseling and make a 7-day quit attempt.
Following completion of the study, participants will be offered standard smoking cessation treatment. Subjects will perform a working memory task (Visual/Spatial N-Back), a sustained attention task (Continuous Performance Task; CPT), a recall memory task (Word Recognition), a cognitive flexibility task (Wisconsin Card Sort Test), and a response inhibition task (Stop Signal Task). The primary outcome is the ability to remain abstinent during a 7-day quit attempt. Secondary outcomes include change in cognitive performance, adherence, and side effects.
This pilot study will provide information about the role of the cholinergic system during brief abstinence and whether enhancing acetylcholine reduces abstinence-induced cognitive symptoms that promote smoking relapse. Information obtained in this study may further establish cognitive performance measures as endophenotypes for nicotine dependence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Galantamine ER | Experimental | Drug: Galantamine ERThe study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Smokers who are between 18 and 60 years of age who self-report smoking at least 10 cigarettes (menthol and non-menthol) per day for at least the last 6 months.
- Healthy as determined by the Study Physician, based on a medical evaluation including medical history and physical examination, and psychiatric evaluation.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and Health Insurance Portability and Accountability Act (HIPAA) form.
- Women of childbearing potential must consent to use a medically accepted method of birth control while participating in the study (e.g., condoms and spermicide, oral contraceptive, Depo-provera injection, contraceptive patch, tubal ligation).
Key exclusion criteria (66 listed)
- Smoking Behavior
- Alcohol/Drugs
- Medical
- Psychiatric Exclusion (as determined by self-report on phone screen and/or through MINI during Medical Screening)
- Medication
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 |
|---|---|---|
| Galantamine ERAlso: Razadyne ERThe study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily. Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER. | Drug | Galantamine ER |
Primary outcome
Number of Days of Abstinence During a 7-day Quit Attempt
Time frame: Days 36-43; following a 5-week dose run-up
Participants will undergo a 6-week study medication period. Day 36 will be the beginning of a 7-day practice quit attempt, during which number of days of abstinence will be assessed.
6 secondary outcomes
Cognitive Performance: Working Memory Reaction Time
Time frame: At Baseline (Day 0), Day 35 (Day before Target Quit Day), and Day 43
Cognitive Performance: Working Memory Accuracy
Time frame: At Baseline (Day 0), Day 35 (Day before Target Quit Day), and Day 43
Subjective Symptoms (Smoking Urges)
Time frame: Days 7, 14, 21, 28, 35, and 43; Baseline session
Side Effects of Galantamine
Time frame: Days 7, 14, 21, 28, 35, 37, 39, and 43; Baseline session
Subjective Symptoms (Negative Affect)
Time frame: Days 7, 14, 21, 28, 35, and 43; Baseline session
Subjective Symptoms (Nicotine Withdrawal)
Time frame: Days 7, 14, 21, 28, 35, and 43; Baseline session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Center for Interdisciplinary Research on Nicotine Addiction homepageLink provided by the sponsor.
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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.
Rebecca Ashare, Ph.D. principal investigator
University of Pennsylvania
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 Galantamine ER in people with Nicotine Addiction, run by University of Pennsylvania 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 4 inclusion and 66 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 26 Dec 2017. 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. 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 2 Jul 2014). 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?
Number of Days of Abstinence During a 7-day Quit Attempt (time frame: Days 36-43; following a 5-week dose run-up). 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 26 Dec 2017.