HealthyPhase 1NCT01089062

Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure

A Phase 1 study testing MAP0004 and IV Dihydroergotamine Mesylate (DHE) in people with Healthy, run by Allergan at 1 site in United States.

Completed

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

Official record

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Trial summary

Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by Oral Inhalation (MAP0004) versus by intravenous (IV) infusion in healthy adult volunteers. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: MAP0004 and IV Dihydroergotamine Mesylate (DHE)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Mar 2010to Dec 2010
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 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Able to provide a signed, executed written informed consent
Healthy non-smoking adult volunteers: Male or Female subjects 18 to 45 years old
Female subjects who are practicing adequate contraception
Stable cardiac status
Normal hemoglobin values
Normal Echocardiogram

Show all 9Show fewer

Normal or not clinically significant 12-lead Electrocardiogram
Demonstrated ability to properly use the Tempo® Inhaler
Subject has not donated blood in the last 56 days

Who cannot join

Contraindication to dihydroergotamine mesylate (DHE)
Use of any excluded concomitant medications within the 10 days prior to Visit 1
History of hemiplegic or basilar migraine
Participation in another investigational trial during the 30 days prior to Visit 1

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke Clinical Research Unit
Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Placebo Controlled, Three-Period Crossover Study Comparing the Acute Effects of Intravenous Dihydroergotamine (DHE) and Orally Inhaled DHE (MAP0004) on Pulmonary Arterial Pressure and Tolerability in Healthy Adults

Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by Oral Inhalation (MAP0004) versus by intravenous (IV) infusion in healthy adult volunteers.

Conditions: Healthy
Being tested: MAP0004, IV Placebo (Saline), Placebo Inhaler, IV Dihydroergotamine Mesylate (DHE)
Keywords: Healthy volunteers

What participants receive

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

MAP0004Drug
1.0 mg orally inhaled MAP0004 administered in Treatment B as per protocol
IV Placebo (Saline)Drug
IV Placebo (Saline) administered in Treatment B and Treatment C as per protocol
Placebo InhalerDrug
Orally inhaled Placebo administered in Treatment A and Treatment C as per protocol.
IV Dihydroergotamine Mesylate (DHE)Drug
Also called D.H.E.45®
IV DHE administered in Treatment A as per protocol

Study groups in NCT01089062
Study group	Role	What they receive
Treatment A, then Treatment B, then Treatment C	Other	The second dose in each treatment group (A,B,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit. Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 2. Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 3. Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 4. Receives: Drug: MAP0004; Drug: IV Placebo (Saline); Drug: Placebo Inhaler; Drug: IV Dihydroergotamine Mesylate (DHE)
Treatment A, then Treatment C, then Treatment B	Other	The second dose in each treatment group (A,C,B) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit. Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 2. Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 3. Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 4. Receives: Drug: MAP0004; Drug: IV Placebo (Saline); Drug: Placebo Inhaler; Drug: IV Dihydroergotamine Mesylate (DHE)
Treatment B, then Treatment A, then Treatment C	Other	The second dose in each treatment group (B,A,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit. Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 2. Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 3. Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 4. Receives: Drug: MAP0004; Drug: IV Placebo (Saline); Drug: Placebo Inhaler; Drug: IV Dihydroergotamine Mesylate (DHE)
Treatment B, then Treatment C, then Treatment A	Other	The second dose in each treatment group (B,C,A) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit. Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 2. Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 3. Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 4. Receives: Drug: MAP0004; Drug: IV Placebo (Saline); Drug: Placebo Inhaler; Drug: IV Dihydroergotamine Mesylate (DHE)
Treatment C, then Treatment A, then Treatment B	Other	The second dose in each treatment group (C,A,B) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit. Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 2. Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 3. Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 4. Receives: Drug: MAP0004; Drug: IV Placebo (Saline); Drug: Placebo Inhaler; Drug: IV Dihydroergotamine Mesylate (DHE)
Treatment C, then Treatment B, then Treatment A	Other	The second dose in each treatment group (C,B,A) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit. Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 2. Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 3. Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 4. Receives: Drug: MAP0004; Drug: IV Placebo (Saline); Drug: Placebo Inhaler; Drug: IV Dihydroergotamine Mesylate (DHE)

What is being measured

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

AUC(0-2hrs) of Pulmonary Arterial Systolic Pressure (PASP) Over Time Post 1st Dose
AUC(0-2hrs) (Area Under the Curve, time 0-2 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg*min). PASP is the highest pressure exerted on the walls of the pulmonary artery.
Measured: 2 hours from time of first dose

Secondary outcomes (5)

Percent of Subjects With an Increase in PASP Greater Than 10mmHg From Baseline to 2 Hours From the First Dose
Pulmonary artery systolic pressure (PASP) is the highest pressure exerted on the walls of the pulmonary artery.
Measured: baseline and 2 hours from the time of first dose
Maximum Change in PASP From Baseline to the Two Hour Period Following the First Dose
Pulmonary artery systolic pressure (PASP) is the highest pressure exerted on the walls of the pulmonary artery.
Measured: baseline and 2 hours from the time of first dose
AUC(0-4hrs) of Pulmonary Arterial Systolic Pressure (PASP) From the Start of the First Dose to Two Hours After the Second Dose
AUC(0-4hrs) (Area Under the Curve, time 0-4 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg*min). PASP is the highest pressure exerted on the walls of the pulmonary artery.
Measured: 4 hours from the time of first dose
Change in Blood Pressure From Baseline After the Two 2-hour Post Dosing Periods
Systolic and diastolic blood pressure measure the lowest and highest pressures against the walls of the arteries. Changes were calculated from 30 minutes pre dose (baseline) to 10 minutes post first and second dose. A positive change from baseline indicates an increase in blood pressure and a negative change indicates a decrease in blood pressure.
Measured: baseline, 10 minutes post 1st dose, 10 minutes post 2nd dose
Change From Baseline in QTc Interval at 14 Minutes After the 1st and 2nd Dose
The corrected QT interval (QTc) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.
Measured: baseline, 14 minutes from time of 1st dose, 14 minutes from time of 2nd dose

Timeline

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

Mar 2010Dec 2010

First posted18 Mar 2010 (estimated)
Study startMar 2010
Primary completionSep 2010
Study completionDec 2010

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 (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01089062
Sponsor's protocol ID: MAP0004-CL-P102
Status last verified: Dec 2013
First submitted: 17 Mar 2010
Last updated: 9 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Noveck RJ, Douglas PS, Chow SC, Mangum B, Kori S, Kellerman DJ. Assessing acute systemic effects of an inhaled drug with serial echocardiography: a placebo-controlled comparison of inhaled and intravenous dihydroergotamine. Drug Des Devel Ther. 2013 Jul 24;7:619-25. doi: 10.2147/DDDT.S44093. Print 2013.
PubMed 23926420

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?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Placebo Controlled, Three-Period Crossover Study Comparing the Acute Effects of Intravenous Dihydroergotamine (DHE) and Orally Inhaled DHE (MAP0004) on Pulmonary Arterial Pressure and Tolerability in Healthy Adults
ClinicalTrials.gov ID: NCT01089062
Acronym / sponsor ID: MAP0004-CL-P102
Conditions: Healthy
Keywords: Healthy volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Collaborators: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Study start: Mar 2010
Primary completion: Sep 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 18 Mar 2010 (estimated)
Results: Posted 22 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by Oral Inhalation (MAP0004) versus by intravenous (IV) infusion in healthy adult volunteers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Treatment A, then Treatment B, then Treatment C	Other	Drug: MAP0004, Drug: IV Placebo (Saline), Drug: Placebo Inhaler, Drug: IV Dihydroergotamine Mesylate (DHE)The second dose in each treatment group (A,B,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit. Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 2. Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 3. Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 4.
Treatment A, then Treatment C, then Treatment B	Other	Drug: MAP0004, Drug: IV Placebo (Saline), Drug: Placebo Inhaler, Drug: IV Dihydroergotamine Mesylate (DHE)The second dose in each treatment group (A,C,B) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit. Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 2. Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 3. Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 4.
Treatment B, then Treatment A, then Treatment C	Other	Drug: MAP0004, Drug: IV Placebo (Saline), Drug: Placebo Inhaler, Drug: IV Dihydroergotamine Mesylate (DHE)The second dose in each treatment group (B,A,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit. Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 2. Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 3. Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 4.
Treatment B, then Treatment C, then Treatment A	Other	Drug: MAP0004, Drug: IV Placebo (Saline), Drug: Placebo Inhaler, Drug: IV Dihydroergotamine Mesylate (DHE)The second dose in each treatment group (B,C,A) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit. Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 2. Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 3. Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 4.
Treatment C, then Treatment A, then Treatment B	Other	Drug: MAP0004, Drug: IV Placebo (Saline), Drug: Placebo Inhaler, Drug: IV Dihydroergotamine Mesylate (DHE)The second dose in each treatment group (C,A,B) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit. Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 2. Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 3. Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 4.
Treatment C, then Treatment B, then Treatment A	Other	Drug: MAP0004, Drug: IV Placebo (Saline), Drug: Placebo Inhaler, Drug: IV Dihydroergotamine Mesylate (DHE)The second dose in each treatment group (C,B,A) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit. Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 2. Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 3. Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 4.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Able to provide a signed, executed written informed consent
Healthy non-smoking adult volunteers: Male or Female subjects 18 to 45 years old
Female subjects who are practicing adequate contraception
Stable cardiac status
Normal hemoglobin values

Key exclusion criteria (4 listed)

Contraindication to dihydroergotamine mesylate (DHE)
Use of any excluded concomitant medications within the 10 days prior to Visit 1
History of hemiplegic or basilar migraine
Participation in another investigational trial during the 30 days prior to Visit 1

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
MAP00041.0 mg orally inhaled MAP0004 administered in Treatment B as per protocol	Drug	Treatment A, then Treatment B, then Treatment C, Treatment A, then Treatment C, then Treatment B, Treatment B, then Treatment A, then Treatment C, Treatment B, then Treatment C, then Treatment A, Treatment C, then Treatment A, then Treatment B, Treatment C, then Treatment B, then Treatment A
IV Placebo (Saline)IV Placebo (Saline) administered in Treatment B and Treatment C as per protocol	Drug	Treatment A, then Treatment B, then Treatment C, Treatment A, then Treatment C, then Treatment B, Treatment B, then Treatment A, then Treatment C, Treatment B, then Treatment C, then Treatment A, Treatment C, then Treatment A, then Treatment B, Treatment C, then Treatment B, then Treatment A
Placebo InhalerOrally inhaled Placebo administered in Treatment A and Treatment C as per protocol.	Drug	Treatment A, then Treatment B, then Treatment C, Treatment A, then Treatment C, then Treatment B, Treatment B, then Treatment A, then Treatment C, Treatment B, then Treatment C, then Treatment A, Treatment C, then Treatment A, then Treatment B, Treatment C, then Treatment B, then Treatment A
IV Dihydroergotamine Mesylate (DHE)Also: D.H.E.45®IV DHE administered in Treatment A as per protocol	Drug	Treatment A, then Treatment B, then Treatment C, Treatment A, then Treatment C, then Treatment B, Treatment B, then Treatment A, then Treatment C, Treatment B, then Treatment C, then Treatment A, Treatment C, then Treatment A, then Treatment B, Treatment C, then Treatment B, then Treatment A

Primary outcome

AUC(0-2hrs) of Pulmonary Arterial Systolic Pressure (PASP) Over Time Post 1st Dose
Time frame: 2 hours from time of first dose
AUC(0-2hrs) (Area Under the Curve, time 0-2 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg*min). PASP is the highest pressure exerted on the walls of the pulmonary artery.

5 secondary outcomes

Percent of Subjects With an Increase in PASP Greater Than 10mmHg From Baseline to 2 Hours From the First Dose
Time frame: baseline and 2 hours from the time of first dose
Maximum Change in PASP From Baseline to the Two Hour Period Following the First Dose
Time frame: baseline and 2 hours from the time of first dose
AUC(0-4hrs) of Pulmonary Arterial Systolic Pressure (PASP) From the Start of the First Dose to Two Hours After the Second Dose
Time frame: 4 hours from the time of first dose
Change in Blood Pressure From Baseline After the Two 2-hour Post Dosing Periods
Time frame: baseline, 10 minutes post 1st dose, 10 minutes post 2nd dose
Change From Baseline in QTc Interval at 14 Minutes After the 1st and 2nd Dose
Time frame: baseline, 14 minutes from time of 1st dose, 14 minutes from time of 2nd dose

Results and safety

Results posted to the registry on 22 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment A, Then B, Then C	4	3
Treatment A, Then C, Then B	4	3
Treatment B, Then A, Then C	4	3
Treatment B, Then C, Then A	4	4
Treatment C, Then A, Then B	4	3
Treatment C, Then B, Then A	4	3

Primary outcome: AUC(0-2hrs) of Pulmonary Arterial Systolic Pressure (PASP) Over Time Post 1st Dose

Time frame: 2 hours from time of first dose. Mean (Standard Deviation). Unit: mmHg*min

Measure	Treatment A n = 18	Treatment B n = 18	Treatment C n = 18
Value	2794.93 (476.66)	2580.06 (389.06)	2497.71 (384.29)

Population analysed: Patients with available data at the required time point were included in the analysis population.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 20 (0%)	19 of 20 (95%)	Not reported
Treatment B	0 of 20 (0%)	10 of 20 (50%)	Not reported
Treatment C	0 of 20 (0%)	6 of 20 (30%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23926420Noveck RJ, Douglas PS, Chow SC, Mangum B, Kori S, Kellerman DJ. Assessing acute systemic effects of an inhaled drug with serial echocardiography: a placebo-controlled comparison of inhaled and intravenous dihydroergotamine. Drug Des Devel Ther. 2013 Jul 24;7:619-25. doi: 10.2147/DDDT.S44093. Print 2013.

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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.

Robert J Noveck, M.D., Ph.D. principal investigator

Duke Clinical Research Unit

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MAP0004 and IV Dihydroergotamine Mesylate (DHE) in people with Healthy, run by Allergan 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 9 inclusion and 4 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 9 Jan 2014. 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 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 22 Oct 2013). 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?

AUC(0-2hrs) of Pulmonary Arterial Systolic Pressure (PASP) Over Time Post 1st Dose (time frame: 2 hours from time of first dose). 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 NCT01089062, which also lists 1 linked publication.

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 9 Jan 2014.