InsomniaSWITCHNCT03511209
Discontinuation of Hypnotics in Older Veterans
A study testing CBTI plus taper method A and CBTI plus taper method B in people with Insomnia, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Sleeping medications, called hypnotics, are often prescribed for insomnia. About one-quarter of Veterans use hypnotics (or bedtime alcohol). Older patients who use hypnotics fall more often and have worse memory than those who do not use them. Stopping hypnotics often reverses these problems. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- CBTI plus taper method A and CBTI plus taper method B
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2018to 27 Nov 2023
- Phase
- Interventional
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 55 years
- Use of lorazepam, alprazolam, temazepam, clonazepam, and/or zolpidem for current or prior insomnia symptoms 2 or more nights per week for at least 3 months
- Current or prior insomnia symptoms
- Available to attend weekly in-person or video sessions over 9 weeks
Who cannot join
- High risk for complications in outpatient hypnotic discontinuation program:
- Seizure disorder
- Supratherapeutic/high baseline hypnotic dose (> diazepam-equivalent of 8 mg/night). Note that for individuals on > 1 of the targeted hypnotics, total baseline dose in diazepam-equivalents will be calculated \& if > 8 mg/night, individual will be excluded.
- High risk of complicated withdrawal; benzodiazepine intoxication or current or past symptoms of complicated benzodiazepine/alcohol withdrawal (e.g., seizure, delirium at baseline)
- Polydrug use (e.g., chronic high dose opioids)
- Unable to keep study medications in secure location
Show all 18Show fewer
- Evidence of prescription fraud (e.g., multiple prescriptions for same drug filled at VA and non-VA pharmacies, diversion)
- Discontinuation of hypnotic not appropriate:
- Study-targeted hypnotic used to treat another clinical condition (e.g., Rapid Eye Movement sleep behavior disorder)
- Not willing to begin hypnotic discontinuation program
- Poor candidate for CBTI:
- Presence of bipolar disorder
- Cognitive impairment (e.g., Mini-Mental State Examination < 24)
- Sleep/wake difficulty is better explained by another sleep disorder such as restless legs syndrome, narcolepsy, insufficient sleep syndrome, or circadian rhythm sleep-wake disorders
- Untreated sleep-disordered breathing defined as:
- Apnea-hypopnea index (AHI) > 30 AHI between 15 and 30 and daytime sleepiness (Epworth Sleepiness Scale > 10)
- Medically/psychiatrically unstable (e.g., recent major hospitalization or planned major surgery during the study; psychosis, suicidal, active alcohol/substance abuse based on history and medical records)
- Unstable housing situation
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
About this study
Official title: The Efficacy of Masked Tapering on Discontinuation of Hypnotics in Older Veterans
Sleeping medications, called hypnotics, are often prescribed for insomnia. About one-quarter of Veterans use hypnotics (or bedtime alcohol). Older patients who use hypnotics fall more often and have worse memory than those who do not use them. Stopping hypnotics often reverses these problems. The Department of Veterans Affairs (VA) is trying to reduce hypnotic use among older adults. Currently, there are two main treatments to help patients stop using hypnotics. The first treatment involves a slow decrease in the daily dose until the hypnotic is ultimately discontinued. For safety, the process of decreasing the daily dose is usually supervised by a physician. The second is a treatment for insomnia called cognitive behavioral therapy for insomnia (CBTI).
This study will compare a novel hypnotic tapering method to the usual tapering method offered to older Veterans. The purpose of the study is to determine if the novel tapering method is more effective than the usual tapering method, both in terms of hypnotic discontinuation and improvement in insomnia severity.
Read more
Participants will be recruited from among Veterans 55 years and older who receive care from one VA Healthcare System. Following a baseline assessment, participants will be randomly assigned to one of the two 8-week treatment groups (66 participants per group). Each treatment group will receive CBTI, however, one group will receive the novel tapering program and the other group the usual tapering program. Follow-up assessments will be conducted at post-treatment and at 6-months after completion of the treatment.
If the novel tapering program is effective, it will represent a treatment option that can be offered to older Veterans who want to discontinue hypnotics. This tapering program could help VA healthcare providers adhere to clinical guidelines that recommend benzodiazepine discontinuation among older adults. A reduction in chronic hypnotic use may in turn reduce the risk of falls and hip fractures, which ultimately may improve the health and quality of life of older Veterans who receive healthcare at the VA.
Read the detailed description
Hypnotics such as benzodiazepines and benzodiazepine receptor agonists are often prescribed for insomnia. Among Veterans attending outpatient clinics, approximately one-quarter use hypnotics (or bedtime alcohol). Hypnotics use is associated with an increased risk of falls and worse cognition in older adults. Discontinuing hypnotics often attenuates or reverses these negative effects, and the Department of Veterans Affairs (VA) has initiatives to reduce hypnotic use among older adults. Current discontinuation strategies focus on tapering off the hypnotic and/or treating insomnia symptoms. Common strategies include supervised gradual taper (SGT), cognitive behavioral therapy targeting hypnotic withdrawal (CBT-HW), cognitive behavioral therapy for insomnia (CBTI), and combination therapy (SGT+CBTI). Yet up to 40% of patients eventually resume use of hypnotics with these strategies, suggesting that other mechanisms need to be targeted to achieve and sustain high rates of non-use.
Objectives: 1) To assess the efficacy of a novel taper plus cognitive behavioral therapy-augmented program on hypnotic discontinuation among older Veterans, 2) to determine the impact of the the novel taper intervention on insomnia severity, 3) to assess the impact of the novel taper intervention on participants' beliefs and expectancies for using hypnotics to improve sleep quality and daytime function, and 4) to assess the efficacy of the novel taper intervention on balance and cognition.
To achieve these objectives, we propose to conduct a randomized clinical trial in older Veterans recruited from a single VA site. Veterans will undergo a 3-step screening process (letter with opt-out card, telephone screen, and in-person screen). Eligible participants (N = 132) will be randomized to 8 weeks of the novel taper intervention (CBTI+taper method A) or CBTI+taper method B. Follow-up assessments will be conducted at post-treatment and 6-months. Key 6-month outcomes will include hypnotic discontinuation and use (measured objectively through lab testing and medical record review/state prescription monitoring database query, and subjectively through sleep diary), insomnia severity, beliefs and expectations about hypnotics, balance, and cognition.
This hypnotic discontinuation program could be an important tool to help older Veterans who want to discontinue hypnotics to achieve this goal.
- Conditions
- Insomnia
- Being tested
- CBTI plus taper method A, CBTI plus taper method B
- Keywords
- Sleep Initiation and Maintenance Disorders, Hypnotics and Sedatives
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTI plus taper method ABehavioural
This intervention includes CBTI plus the novel hypnotic tapering method.
CBTI plus taper method BBehavioural
This intervention includes CBTI plus the usual hypnotic tapering method used by the VA.
| Study group | Role | What they receive |
|---|---|---|
| CBTI plus Taper method A | Experimental | Participants in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBTI) plus the novel hypnotic tapering method. Receives: Behavioral: CBTI plus taper method A |
| CBTI plus Taper method B | Active comparator | Participants in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBTI) plus the usual tapering method used by the VA. Receives: Behavioral: CBTI plus taper method B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Hypnotic Discontinuation
The percentage of participants who had stopped taking a benzodiazepine or z-drug at follow-up. This outcome was measured with 7-day self-reported medication logs.
Measured: 6 months after treatment ends (which is an average of 8 months from randomization)
Insomnia Severity Index Score
Mean score on Insomnia Severity Index. This 7-item scale measures self-reported severity of insomnia symptoms.
Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
Measured: 6 months after treatment ends (which is an average of 8 months from randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start10 Dec 2018
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Constance H Fung, MD MSHS, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511209
- Sponsor's protocol ID
- IIR 17-234
- Acronym
- SWITCH
- Status last verified
- Nov 2024
- First submitted
- 18 Apr 2018
- Last updated
- 14 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fung CH, Martin JL, Alessi C, Dzierzewski JM, Cook IA, Moore A, Grinberg A, Zeidler M, Kierlin L. Hypnotic Discontinuation Using a Blinded (Masked) Tapering Approach: A Case Series. Front Psychiatry. 2019 Oct 24;10:717. doi: 10.3389/fpsyt.2019.00717. eCollection 2019.
PubMed 31708806McCarthy M, Mak S, Kaufmann CN, Lum HD, Fung CH. Care coordination needs for deprescribing benzodiazepines and benzodiazepine receptor agonists. Res Social Adm Pharm. 2022 Apr;18(4):2691-2694. doi: 10.1016/j.sapharm.2021.06.025. Epub 2021 Jul 1.
PubMed 34229951Gutierrez L, Ghadimi S, Krall A, Hampson E, Grinberg AM, Moore AA, Dzierzewski JM, Alessi C, Martin JL, Fung CH. Posttraumatic Stress Disorder Risk and Benzodiazepine Dependence in Older Veterans with Insomnia Symptoms. Clin Gerontol. 2022 Mar-Apr;45(2):414-418. doi: 10.1080/07317115.2021.1954123. Epub 2021 Aug 4.
PubMed 34346855Ghadimi S, Grinberg A, Mitchell MN, Alessi C, Moore AA, Martin JL, Dzierzewski JM, Kelly M, Badr MS, Guzman A, Smith JP, Zeidler M, Fung CH. Sleep characteristics and use of multiple benzodiazepine receptor agonists in older adults. J Am Geriatr Soc. 2023 Dec;71(12):3924-3927. doi: 10.1111/jgs.18528. Epub 2023 Aug 1. No abstract available.
PubMed 37526436Fung CH, Alessi C, Martin JL, Josephson K, Kierlin L, Dzierzewski JM, Moore AA, Badr MS, Zeidler M, Kelly M, Smith JP, Cook IA, Der-Mcleod E, Ghadimi S, Naeem S, Partch L, Guzman A, Grinberg A, Mitchell M. Masked Taper With Behavioral Intervention for Discontinuation of Benzodiazepine Receptor Agonists: A Randomized Clinical Trial. JAMA Intern Med. 2024 Dec 1;184(12):1448-1456. doi: 10.1001/jamainternmed.2024.5020.
PubMed 39374004
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Masked Tapering on Discontinuation of Hypnotics in Older Veterans
- ClinicalTrials.gov ID
- NCT03511209
- Acronym / sponsor ID
- SWITCH / IIR 17-234
- Conditions
- Insomnia
- Keywords
- Sleep Initiation and Maintenance Disorders, Hypnotics and Sedatives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 27 Apr 2018 (actual)
- Results
- Posted 14 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sleeping medications, called hypnotics, are often prescribed for insomnia. About one-quarter of Veterans use hypnotics (or bedtime alcohol). Older patients who use hypnotics fall more often and have worse memory than those who do not use them. Stopping hypnotics often reverses these problems. The Department of Veterans Affairs (VA) is trying to reduce hypnotic use among older adults. Currently, there are two main treatments to help patients stop using hypnotics. The first treatment involves a slow decrease in the daily dose until the hypnotic is ultimately discontinued. For safety, the process of decreasing the daily dose is usually supervised by a physician. The second is a treatment for insomnia called cognitive behavioral therapy for insomnia (CBTI).
This study will compare a novel hypnotic tapering method to the usual tapering method offered to older Veterans. The purpose of the study is to determine if the novel tapering method is more effective than the usual tapering method, both in terms of hypnotic discontinuation and improvement in insomnia severity.
Participants will be recruited from among Veterans 55 years and older who receive care from one VA Healthcare System. Following a baseline assessment, participants will be randomly assigned to one of the two 8-week treatment groups (66 participants per group). Each treatment group will receive CBTI, however, one group will receive the novel tapering program and the other group the usual tapering program. Follow-up assessments will be conducted at post-treatment and at 6-months after completion of the treatment.
If the novel tapering program is effective, it will represent a treatment option that can be offered to older Veterans who want to discontinue hypnotics. This tapering program could help VA healthcare providers adhere to clinical guidelines that recommend benzodiazepine discontinuation among older adults. A reduction in chronic hypnotic use may in turn reduce the risk of falls and hip fractures, which ultimately may improve the health and quality of life of older Veterans who receive healthcare at the VA.
Detailed description
Hypnotics such as benzodiazepines and benzodiazepine receptor agonists are often prescribed for insomnia. Among Veterans attending outpatient clinics, approximately one-quarter use hypnotics (or bedtime alcohol). Hypnotics use is associated with an increased risk of falls and worse cognition in older adults. Discontinuing hypnotics often attenuates or reverses these negative effects, and the Department of Veterans Affairs (VA) has initiatives to reduce hypnotic use among older adults. Current discontinuation strategies focus on tapering off the hypnotic and/or treating insomnia symptoms. Common strategies include supervised gradual taper (SGT), cognitive behavioral therapy targeting hypnotic withdrawal (CBT-HW), cognitive behavioral therapy for insomnia (CBTI), and combination therapy (SGT+CBTI). Yet up to 40% of patients eventually resume use of hypnotics with these strategies, suggesting that other mechanisms need to be targeted to achieve and sustain high rates of non-use.
Objectives: 1) To assess the efficacy of a novel taper plus cognitive behavioral therapy-augmented program on hypnotic discontinuation among older Veterans, 2) to determine the impact of the the novel taper intervention on insomnia severity, 3) to assess the impact of the novel taper intervention on participants' beliefs and expectancies for using hypnotics to improve sleep quality and daytime function, and 4) to assess the efficacy of the novel taper intervention on balance and cognition.
To achieve these objectives, we propose to conduct a randomized clinical trial in older Veterans recruited from a single VA site. Veterans will undergo a 3-step screening process (letter with opt-out card, telephone screen, and in-person screen). Eligible participants (N = 132) will be randomized to 8 weeks of the novel taper intervention (CBTI+taper method A) or CBTI+taper method B. Follow-up assessments will be conducted at post-treatment and 6-months. Key 6-month outcomes will include hypnotic discontinuation and use (measured objectively through lab testing and medical record review/state prescription monitoring database query, and subjectively through sleep diary), insomnia severity, beliefs and expectations about hypnotics, balance, and cognition.
This hypnotic discontinuation program could be an important tool to help older Veterans who want to discontinue hypnotics to achieve this goal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBTI plus Taper method A | Experimental | Behavioral: CBTI plus taper method AParticipants in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBTI) plus the novel hypnotic tapering method. |
| CBTI plus Taper method B | Active comparator | Behavioral: CBTI plus taper method BParticipants in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBTI) plus the usual tapering method used by the VA. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >= 55 years
- Use of lorazepam, alprazolam, temazepam, clonazepam, and/or zolpidem for current or prior insomnia symptoms 2 or more nights per week for at least 3 months
- Current or prior insomnia symptoms
- Available to attend weekly in-person or video sessions over 9 weeks
Key exclusion criteria (18 listed)
- Seizure disorder
- Supratherapeutic/high baseline hypnotic dose (> diazepam-equivalent of 8 mg/night). Note that for individuals on > 1 of the targeted hypnotics, total baseline dose in diazepam-equivalents will be calculated \& if > 8 mg/night, individual will be excluded.
- High risk of complicated withdrawal; benzodiazepine intoxication or current or past symptoms of complicated benzodiazepine/alcohol withdrawal (e.g., seizure, delirium at baseline)
- Polydrug use (e.g., chronic high dose opioids)
- Unable to keep study medications in secure location
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 |
|---|---|---|
| CBTI plus taper method AThis intervention includes CBTI plus the novel hypnotic tapering method. | Behavioural | CBTI plus Taper method A |
| CBTI plus taper method BThis intervention includes CBTI plus the usual hypnotic tapering method used by the VA. | Behavioural | CBTI plus Taper method B |
Primary outcome
Rates of Hypnotic Discontinuation
Time frame: 6 months after treatment ends (which is an average of 8 months from randomization)
The percentage of participants who had stopped taking a benzodiazepine or z-drug at follow-up. This outcome was measured with 7-day self-reported medication logs.
Insomnia Severity Index Score
Time frame: 6 months after treatment ends (which is an average of 8 months from randomization)
Mean score on Insomnia Severity Index. This 7-item scale measures self-reported severity of insomnia symptoms. Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31708806Fung CH, Martin JL, Alessi C, Dzierzewski JM, Cook IA, Moore A, Grinberg A, Zeidler M, Kierlin L. Hypnotic Discontinuation Using a Blinded (Masked) Tapering Approach: A Case Series. Front Psychiatry. 2019 Oct 24;10:717. doi: 10.3389/fpsyt.2019.00717. eCollection 2019.
- Results publication: PubMed 34229951McCarthy M, Mak S, Kaufmann CN, Lum HD, Fung CH. Care coordination needs for deprescribing benzodiazepines and benzodiazepine receptor agonists. Res Social Adm Pharm. 2022 Apr;18(4):2691-2694. doi: 10.1016/j.sapharm.2021.06.025. Epub 2021 Jul 1.
- Results publication: PubMed 34346855Gutierrez L, Ghadimi S, Krall A, Hampson E, Grinberg AM, Moore AA, Dzierzewski JM, Alessi C, Martin JL, Fung CH. Posttraumatic Stress Disorder Risk and Benzodiazepine Dependence in Older Veterans with Insomnia Symptoms. Clin Gerontol. 2022 Mar-Apr;45(2):414-418. doi: 10.1080/07317115.2021.1954123. Epub 2021 Aug 4.
- Results publication: PubMed 37526436Ghadimi S, Grinberg A, Mitchell MN, Alessi C, Moore AA, Martin JL, Dzierzewski JM, Kelly M, Badr MS, Guzman A, Smith JP, Zeidler M, Fung CH. Sleep characteristics and use of multiple benzodiazepine receptor agonists in older adults. J Am Geriatr Soc. 2023 Dec;71(12):3924-3927. doi: 10.1111/jgs.18528. Epub 2023 Aug 1. No abstract available.
- Results publication: PubMed 39374004Fung CH, Alessi C, Martin JL, Josephson K, Kierlin L, Dzierzewski JM, Moore AA, Badr MS, Zeidler M, Kelly M, Smith JP, Cook IA, Der-Mcleod E, Ghadimi S, Naeem S, Partch L, Guzman A, Grinberg A, Mitchell M. Masked Taper With Behavioral Intervention for Discontinuation of Benzodiazepine Receptor Agonists: A Randomized Clinical Trial. JAMA Intern Med. 2024 Dec 1;184(12):1448-1456. doi: 10.1001/jamainternmed.2024.5020.
- 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.
Constance H Fung, MD MSHS principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBTI plus taper method A and CBTI plus taper method B in people with Insomnia, run by VA Office of Research and Development 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 18 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 14 Nov 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2024). 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?
Rates of Hypnotic Discontinuation (time frame: 6 months after treatment ends (which is an average of 8 months from randomization)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03511209, which also lists 5 linked publications.
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 14 Nov 2024.