A Study of V950 in People With Alzheimer Disease (V950-001 AM7)

A Phase 1 study testing V950 and ISCOMATRIX™ in people with Alzheimer Disease, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to test the safety, tolerability and the immune response to an investigational vaccine, V950, with or without ISCOMATRIX™ (IMX). Read more about this study

Who is it for?: Ages 55 years and older
Conditions the study is for: Alzheimer Disease
What is being tested?: V950 and ISCOMATRIX™
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 86 participants
Where: No sites listed yet
Study dates: Mar 2007to Jan 2012
Phase: Phase 1
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

Patient has mild to moderate Alzheimer Disease
Women cannot be able to get pregnant
Patient has a reliable caregiver, who will attend all visits and answer questions about the patient

Who cannot join

Patient lives in a nursing home or facility
Patient has another neurological or neurodegenerative disorder
Patient has a history of stroke
Patient uses illicit drugs or has a history of drug/alcohol abuse
Patient has received blood or blood derived products within 6 months

About this study

Official title: A Double-Blind, Randomized, Placebo-Controlled, Dose Escalating Study to Evaluate the Safety, Tolerability, and Immunogenicity of V950 Formulated on Aluminum-Containing Adjuvant With or Without ISCOMATRIX™ in Patients With Alzheimer Disease

The purpose of this study is to test the safety, tolerability and the immune response to an investigational vaccine, V950, with or without ISCOMATRIX™ (IMX).

Conditions: Alzheimer Disease
Being tested: V950, ISCOMATRIX™, Placebo to V950
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

V950Biological
V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.
ISCOMATRIX™Biological
ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.
Placebo to V950Biological

Study groups in NCT00464334
Study group	Role	What they receive
Placebo to V950/IMX 0 mcg	Experimental	Participants receive Placebo to V950/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. Receives: Biological: ISCOMATRIX™; Biological: Placebo to V950
Placebo to V950/IMX 16 mcg	Experimental	Participants receive Placebo to V950/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. Receives: Biological: ISCOMATRIX™; Biological: Placebo to V950
V950 0.5 mcg/IMX 0 mcg	Experimental	Participants receive V950 0.5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. Receives: Biological: V950; Biological: ISCOMATRIX™
V950 0.5 mcg/IMX 16 mcg	Experimental	Participants receive V950 0.5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. Receives: Biological: V950; Biological: ISCOMATRIX™
V950 0.5 mcg/IMX 47 mcg	Experimental	Participants receive V950 0.5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. Receives: Biological: V950; Biological: ISCOMATRIX™
V950 0.5 mcg/IMX 94 mcg	Experimental	Participants receive V950 0.5 mcg/IMX 94 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. Receives: Biological: V950; Biological: ISCOMATRIX™
V950 5 mcg/IMX 0 mcg	Experimental	Participants receive V950 5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. Receives: Biological: V950; Biological: ISCOMATRIX™
V950 5 mcg/IMX 16 mcg	Experimental	Participants receive V950 5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. Receives: Biological: V950; Biological: ISCOMATRIX™
V950 5 mcg/IMX 47 mcg	Experimental	Participants receive V950 5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. Receives: Biological: V950; Biological: ISCOMATRIX™
V950 50 mcg/IMX 0 mcg	Experimental	Participants receive V950 50 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. Receives: Biological: V950; Biological: ISCOMATRIX™
V950 50 mcg/IMX 16 mcg	Experimental	Participants receive V950 50 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. Receives: Biological: V950; Biological: ISCOMATRIX™

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experienced at Least One Adverse Event
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Measured: Up to 4 years after first dose of vaccine
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
This is a measure of the number of participants who discontinued study drug because of an adverse event. An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Measured: Up to 6 months after first dose of vaccine
Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7
The level of Aβ Peptide 1-40 specific antibodies was measured as the geometric mean titer (GMT) one month after the third dose (Month 7) of vaccine using an enzyme-linked immunosorbent assay (ELISA).
Measured: Month 7
Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies
The Aβ Peptide 1-40 specific immunogenicity of 3-dose regimen of V950 was measured one month after the third dose (Month 7) of vaccine by the GMT fold change of Aβ 1-40 specific antibodies compared to Baseline (Month 0) using ELISA.
Measured: Baseline and Month 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007Jan 2012

First posted23 Apr 2007 (estimated)
Study startMar 2007
Primary completionJan 2012
Study completionJan 2012

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 Alzheimer DiseaseStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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 1
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00464334
Sponsor's protocol ID: V950-001
Other IDs: 2007_518
Status last verified: Sep 2015
First submitted: 20 Apr 2007
Last updated: 25 Sep 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
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All Alzheimer Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Randomized, Placebo-Controlled, Dose Escalating Study to Evaluate the Safety, Tolerability, and Immunogenicity of V950 Formulated on Aluminum-Containing Adjuvant With or Without ISCOMATRIX™ in Patients With Alzheimer Disease
ClinicalTrials.gov ID: NCT00464334
Acronym / sponsor ID: V950-001
Conditions: Alzheimer Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 23 Apr 2007 (estimated)
Results: Posted 18 Dec 2012

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 study is to test the safety, tolerability and the immune response to an investigational vaccine, V950, with or without ISCOMATRIX™ (IMX).

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 11

Arm	Type	Receives
Placebo to V950/IMX 0 mcg	Experimental	Biological: ISCOMATRIX™, Biological: Placebo to V950Participants receive Placebo to V950/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Placebo to V950/IMX 16 mcg	Experimental	Biological: ISCOMATRIX™, Biological: Placebo to V950Participants receive Placebo to V950/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 0.5 mcg/IMX 0 mcg	Experimental	Biological: V950, Biological: ISCOMATRIX™Participants receive V950 0.5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 0.5 mcg/IMX 16 mcg	Experimental	Biological: V950, Biological: ISCOMATRIX™Participants receive V950 0.5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 0.5 mcg/IMX 47 mcg	Experimental	Biological: V950, Biological: ISCOMATRIX™Participants receive V950 0.5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 0.5 mcg/IMX 94 mcg	Experimental	Biological: V950, Biological: ISCOMATRIX™Participants receive V950 0.5 mcg/IMX 94 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 5 mcg/IMX 0 mcg	Experimental	Biological: V950, Biological: ISCOMATRIX™Participants receive V950 5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 5 mcg/IMX 16 mcg	Experimental	Biological: V950, Biological: ISCOMATRIX™Participants receive V950 5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 5 mcg/IMX 47 mcg	Experimental	Biological: V950, Biological: ISCOMATRIX™Participants receive V950 5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 50 mcg/IMX 0 mcg	Experimental	Biological: V950, Biological: ISCOMATRIX™Participants receive V950 50 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 50 mcg/IMX 16 mcg	Experimental	Biological: V950, Biological: ISCOMATRIX™Participants receive V950 50 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patient has mild to moderate Alzheimer Disease
Women cannot be able to get pregnant
Patient has a reliable caregiver, who will attend all visits and answer questions about the patient

Key exclusion criteria (5 listed)

Patient lives in a nursing home or facility
Patient has another neurological or neurodegenerative disorder
Patient has a history of stroke
Patient uses illicit drugs or has a history of drug/alcohol abuse
Patient has received blood or blood derived products within 6 months

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
V950V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.	Biological	V950 0.5 mcg/IMX 0 mcg, V950 0.5 mcg/IMX 16 mcg, V950 0.5 mcg/IMX 47 mcg, V950 0.5 mcg/IMX 94 mcg, V950 5 mcg/IMX 0 mcg, V950 5 mcg/IMX 16 mcg, V950 5 mcg/IMX 47 mcg, V950 50 mcg/IMX 0 mcg, V950 50 mcg/IMX 16 mcg
ISCOMATRIX™ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.	Biological	Placebo to V950/IMX 0 mcg, Placebo to V950/IMX 16 mcg, V950 0.5 mcg/IMX 0 mcg, V950 0.5 mcg/IMX 16 mcg, V950 0.5 mcg/IMX 47 mcg, V950 0.5 mcg/IMX 94 mcg, V950 5 mcg/IMX 0 mcg, V950 5 mcg/IMX 16 mcg, V950 5 mcg/IMX 47 mcg, V950 50 mcg/IMX 0 mcg, V950 50 mcg/IMX 16 mcg
Placebo to V950	Biological	Placebo to V950/IMX 0 mcg, Placebo to V950/IMX 16 mcg

Primary outcome

Number of Participants Who Experienced at Least One Adverse Event
Time frame: Up to 4 years after first dose of vaccine
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Time frame: Up to 6 months after first dose of vaccine
This is a measure of the number of participants who discontinued study drug because of an adverse event. An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7
Time frame: Month 7
The level of Aβ Peptide 1-40 specific antibodies was measured as the geometric mean titer (GMT) one month after the third dose (Month 7) of vaccine using an enzyme-linked immunosorbent assay (ELISA).
Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies
Time frame: Baseline and Month 7
The Aβ Peptide 1-40 specific immunogenicity of 3-dose regimen of V950 was measured one month after the third dose (Month 7) of vaccine by the GMT fold change of Aβ 1-40 specific antibodies compared to Baseline (Month 0) using ELISA.

Results and safety

Results posted to the registry on 18 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo to V950/IMX 0 mcg	5	4
Placebo to V950/IMX 16 mcg	13	5
V950 0.5 mcg/IMX 0 mcg	8	3
V950 0.5 mcg/IMX 16 mcg	8	4
V950 0.5 mcg/IMX 47 mcg	7	3
V950 0.5 mcg/IMX 94 mcg	7	3
V950 5 mcg/IMX 0 mcg	9	6
V950 5 mcg/IMX 16 mcg	8	7
V950 5 mcg/IMX 47 mcg	8	2
V950 50 mcg/IMX 0 mcg	5	4
V950 50 mcg/IMX 16 mcg	8	4

Primary outcome: Number of Participants Who Experienced at Least One Adverse Event

Time frame: Up to 4 years after first dose of vaccine. Number. Unit: participants

Measure	Placebo to V950/ IMX 0 mcg n = 5	Placebo to V950/ IMX 16 mcg n = 13	V950 0.5 mcg / IMX 0 mcg n = 8	V950 0.5 mcg / IMX 16 mcg n = 8	V950 0.5 mcg / IMX 47 mcg n = 7	V950 0.5 mcg / IMX 94 mcg n = 7	V950 5 mcg / IMX 0 mcg n = 9	V950 5 mcg / IMX 16 mcg n = 8	V950 5 mcg / IMX 47 mcg n = 8	V950 50 mcg / IMX 0 mcg n = 5	V950 50 mcg / IMX 16 mcg n = 8
Value	4	11	7	8	6	7	9	8	8	5	8

Population analysed: Population consists of all participants who received at least one dose of vaccine.

Primary outcome: Number of Participants Who Discontinued Study Drug Due to an Adverse Event

Time frame: Up to 6 months after first dose of vaccine. Number. Unit: participants

Measure	Placebo to V950/ IMX 0 mcg n = 5	Placebo to V950/ IMX 16 mcg n = 13	V950 0.5 mcg / IMX 0 mcg n = 8	V950 0.5 mcg / IMX 16 mcg n = 8	V950 0.5 mcg / IMX 47 mcg n = 7	V950 0.5 mcg / IMX 94 mcg n = 7	V950 5 mcg / IMX 0 mcg n = 9	V950 5 mcg / IMX 16 mcg n = 8	V950 5 mcg / IMX 47 mcg n = 8	V950 50 mcg / IMX 0 mcg n = 5	V950 50 mcg / IMX 16 mcg n = 8
Value	0	0	0	1	1	0	1	0	3	1	2

Population analysed: Population consists of all participants who received at least one dose of vaccine.

Primary outcome: Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7

Time frame: Month 7. Geometric mean (95% Confidence Interval). Unit: ng/mL

Measure	Placebo to V950/IMX 0 mcg n = 4	Placebo to V950/IMX 16 mcg n = 4	V950 0.5 mcg/IMX 0 mcg n = 8	V950 0.5 mcg/IMX 16 mcg n = 7	V950 0.5 mcg/IMX 47 mcg n = 1	V950 0.5 mcg/IMX 94 mcg n = 6	V950 5 mcg/IMX 0 mcg n = 9	V950 5 mcg/IMX 16 mcg n = 1	V950 5 mcg/IMX 47 mcg n = 6	V950 50 mcg/IMX 0 mcg n = 0	V950 50 mcg/IMX 16 mcg n = 5
Value	363 (161 to 729)	542.08 (310.16 to 818.02)	855 (575 to 1275)	443 (345 to 560)	990 (990 to 990)	2208.02 (628.53 to 12105)	725 (378 to 1385)	3835 (3835 to 3835)	1277.38 (604.83 to 2453.4)	–	935.55 (447.14 to 1728.0)

Population analysed: Population consists of all participants who received three doses of vaccine and had no protocol violations. No participants in the V950 50 mcg/IMX 0 mcg group had data for the Month 7 evaluation.

Primary outcome: Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies

Time frame: Baseline and Month 7. Geometric mean (95% Confidence Interval). Unit: fold change

Measure	Placebo to V950/ IMX 0 mcg n = 4	Placebo to V950/ IMX 16 mcg n = 4	V950 0.5 mcg / IMX 0 mcg n = 8	V950 0.5 mcg / IMX 16 mcg n = 7	V950 0.5 mcg / IMX 47 mcg n = 1	V950 0.5 mcg / IMX 94 mcg n = 6	V950 5 mcg / IMX 0 mcg n = 9	V950 5 mcg / IMX 16 mcg n = 1	V950 5 mcg / IMX 47 mcg n = 5	V950 50 mcg / IMX 0 mcg n = 0	V950 50 mcg / IMX 16 mcg n = 5
Value	0.89 (0.70 to 1.16)	0.76 (0.49 to 1.06)	0.98 (0.79 to 1.17)	1.02 (0.82 to 1.27)	0.15 (0.15 to 0.15)	2.68 (1.03 to 8.66)	0.74 (0.18 to 1.80)	2.27 (2.27 to 2.27)	1.38 (0.84 to 2.78)	–	1.84 (1.29 to 2.67)

Adverse events

Time frame: Up to 4 years after first dose of vaccine. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo to V950/ IMX 0 mcg	1 of 5 (20%)	4 of 5 (80%)	Not reported
Placebo to V950/ IMX 16 mcg	0 of 13 (0%)	11 of 13 (84.6%)	Not reported
V950 0.5 mcg / IMX 0 mcg	2 of 8 (25%)	7 of 8 (87.5%)	Not reported
V950 0.5 mcg / IMX 16 mcg	2 of 8 (25%)	8 of 8 (100%)	Not reported
V950 0.5 mcg / IMX 47 mcg	3 of 7 (42.9%)	6 of 7 (85.7%)	Not reported
V950 0.5 mcg / IMX 94 mcg	1 of 7 (14.3%)	7 of 7 (100%)	Not reported
V950 5 mcg / IMX 0 mcg	4 of 9 (44.4%)	9 of 9 (100%)	Not reported
V950 5 mcg / IMX 16 mcg	1 of 8 (12.5%)	8 of 8 (100%)	Not reported
V950 5 mcg / IMX 47 mcg	2 of 8 (25%)	8 of 8 (100%)	Not reported
V950 50 mcg / IMX 0 mcg	1 of 5 (20%)	5 of 5 (100%)	Not reported
V950 50 mcg / IMX 16 mcg	0 of 8 (0%)	8 of 8 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing V950 and ISCOMATRIX™ in people with Alzheimer Disease, run by Merck Sharp & Dohme LLC.

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 3 inclusion and 5 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 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 18 Dec 2012). 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 Participants Who Experienced at Least One Adverse Event (time frame: Up to 4 years after first dose of vaccine). The study lists 4 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 NCT00464334.

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 25 Sep 2015.