Attention-Deficit/Hyperactivity DisorderPhase 4NCT00877487

Safety and Efficacy of Vyvanse in Adults With Attention-Deficit/Hyperactivity Disorder

A Phase 4 study testing SPD489 (Lisdexamfetamine dimesylate) in people with Attention-Deficit/Hyperactivity Disorder, run by Shire at 55 sites 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

The primary objective of this study is to evaluate the maintenance of efficacy, as measured by Adult ADHD Rating Scale with Prompts (Adult ADHD-RS with prompts) and Clinical Global Impression - Severity (CGI-S) scores, through a randomized withdrawal design when subjects with ADHD have been on stable treatment with… Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Attention-Deficit/Hyperactivity Disorder
What is being tested?: SPD489 (Lisdexamfetamine dimesylate)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 123 participants
Where: 55 sitesUnited States
Study dates: 30 Apr 2009to 8 Jul 2010
Phase: Phase 4
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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Subject must be 18-55 years of age, inclusive at the time of consent.
Female subjects must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at baseline and agree to comply with any applicable contraceptive requirements of the protocol.
Subject has a documented diagnosis of ADHD or meets DSM-IV-TR™ with adult prompts criteria by history for a primary diagnosis of ADHD prior to treatment.
Subject has a Baseline score of <22 using the Adult ADHD-RS with prompts and CGI-S score ≤3.
Subject has been on stable treatment with commercial SPD489 (30, 50, or 70mg) for a minimum of at least 6 months preceding the Screening Visit with acceptable tolerability.Prior treatment with commercial SPD489 in the 6 months preceding the Screening Visit must be documented by prescription records, prescribing physician notes, or pharmacy records. Those subjects whose primary care physician (PCP) is someone other than the Principal Investigator (PI) will be required to provide the above documentation to the site.
Subject must have a minimum level of intellectual functioning, as determined by the Investigator.

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Subject is willing and able to comply with all the testing and requirements defined in this protocol.
Subject is able to swallow a capsule.
Subject must be able to provide written, personally signed and dated informed consent to participate in the study, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E627 and applicable regulations, before completing any study-related procedures.

Who cannot join

Subject has a current comorbid psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms. Prohibited disorders include those associated with diagnoses including but not limited to any severe comorbid Axis II disorder or severe Axis I disorder (such as Post Traumatic Stress Disorder [PTSD], psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder). Other symptomatic manifestations (such as agitated states)that contraindicate treatment with SPD489 or confound efficacy or safety assessments in the opinion of the examining physician are also prohibited. Comorbid psychiatric diagnoses will be established by the psychiatric evaluation that includes the Structured Clinical Interview for DSM-IV-TR™ disorders (SCID-I).
Subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently demonstrating suicidal ideation.
The subject has a body mass index (BMI) of <18.5 or ≥40.
Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Similarly, the subject will be excluded if he or she has any additional condition(s) that in the Investigator's opinion would prohibit the subject from completing the study or would not be in the best interest of the subject. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
Subject has a history of seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.
Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, transient ischemic attack or stroke or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.

Show all 21Show fewer

Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
Subject has any clinically significant ECG or clinically significant laboratory abnormality at Screening.
Subject has current abnormal thyroid function, as defined as abnormal Screening thyroid stimulating hormone (TSH) and thyroxine (T4). Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
Subject has a history of moderate to severe hypertension or has a resting sitting systolic blood pressure >139mmHg or diastolic blood pressure >89mmHg. Subjects with well-controlled mild or moderate hypertension on a single antihypertensive agent are allowed.
Subject is taking any medication that is excluded (Please refer to Table 2).
Subject has a documented allergy, hypersensitivity, or intolerance to amphetamines.
Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine) in accordance with DSM-IV-TR™ criteria.
Subject has a positive urine drug result at Screening (with the exception of subject's current stimulant therapy).
Subject has taken an investigational compound that has a central nervous system(CNS) effect or taken part in a clinical trial for ADHD 6 months prior to the Screening Visit.
Subject has taken part in an investigational trial within the 30 days prior to the Screening Visit.
Subject has glaucoma.
Subject is taking other medications that have CNS effects or affect performance, such as chronic use of sedating antihistamines and decongestant sympathomimetics (7 days prior to Screening). Stable use of bronchodilator inhalers is not exclusionary.
Subject is female and pregnant or lactating.
Subjects who have previously been enrolled into this study and subsequently withdrawn.
Subject is not well controlled on SPD489 with acceptable tolerability (Adult ADHD-RS with prompts score ≥22).

Trial locations and contacts

55 sites in 1 country.

City, postcode or hospital

55 sites in 1 country

United States55 sites

Atlanta Center for Medical Research
Atlanta, Georgia, 30308
FutureSearch Trials
Austin, Texas, 78756
Northwest Clinical Research Center
Bellevue, Washington, 98004
Florida Clinical Research Center
Bradenton, Florida, 34208
Vermont Clinical Study Center
Burlington, Vermont, 05401
Carolina Clinical Trials, Inc.
Charleston, South Carolina, 29407
Psychiatric Alliance of the Blue Ridge
Charlottesville, Virginia, 22903
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
UHCMC/ Discovery and Wellness Center for Children
Cleveland, Ohio, 44106
Introspect of Buxmont, Ltd.
Colmar, Pennsylvania, 18915
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231
Valley Clinical Research, Inc.
El Centro, California, 92243
Prarie St. Johns/ Odyssey Research
Fargo, North Dakota, 58104
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912
Calcagno Pediatrics
Gresham, Oregon, 97030
Colorado Clinica Trials, Inc.
Highlands Ranch, Colorado, 80130
Bayou City Reserch, Ltd.
Houston, Texas, 77007
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, 32216
Joliet Center for Clinical Research
Joliet, Illinois, 60435
Eastside Therapeutic Resource
Kirkland, Washington, 98033
Center for Psychiatry and Behavioral Medicine Inc.
Las Vegas, Nevada, 89128
Fidelity Clinical Research, Inc.
Lauderhill, Florida, 33319
Capstone Clinical Research
Libertyville, Illinois, 60048
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, 68510
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205
Westex Clinical Investigators
Lubbock, Texas, 79423
CNS Healthcare
Memphis, Tennessee, 38119
Dean Foundation
Middleton, Wisconsin, 53562
Dominion Clinical Research
Midlothian, Virginia, 23112
CIENTIFICA, Inc
Newton, Kansas, 67114
IPS Research Company
Oklahoma City, Oklahoma, 73703
Aspen Clinical Research
Orem, Utah, 84058
CNS Healthcare
Orlando, Florida, 32806
Psychiatric Associates
Overland Park, Kansas, 66211
Vince and Associates Clinical Research
Overland Park, Kansas, 66212
Pedia Research LLC
Owensboro, Kentucky, 42301
Four Rivers Clinical Research
Paducah, Kentucky, 42003
Youth and Family Research Program
Pittsburgh, Pennsylvania, 15213
Clinical Trial Technology Inc.
Prairie Village, Kansas, 66206
Global Medical Institutes, LLC. Princeton Medical Institute
Princeton, New Jersey, 08540
Richard H. Weisler, MD, PA & Associates
Raleigh, North Carolina, 27609
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307
Study site
Rockville, Maryland, 20852
Peninsula Research Associates, Inc
Rolling Hills Estates, California, 90274
Northwest Behavioral Research Center
Roswell, Georgia, 30076
Midwest Research Group/ St. Charles Psychiatric Associates
Saint Charles, Missouri, 63301
Cerebral Research, LLC
San Antonio, Texas, 78247
PCSD Feighner Research
San Diego, California, 92108
Miami Research Associates
South Miami, Florida, 33143
Richmond Behavioral Associates
Staten Island, New York, 10312
The Behavioral Medicine Clinic of NW Michigan
Traverse City, Michigan, 49686
Behavioral Medical Center-Troy
Troy, Michigan, 48083
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407
Elite Clinical Trials, Inc.
Wildomar, California, 92595
Neuropsychiatric Associates
Woodstock, Vermont, 05091

Other trials in United States

About this study

Official title: A Phase 4, Double-Blind, Multi-Center, Placebo-Controlled, Randomized Withdrawal, Safety and Efficacy Study of SPD489 in Adults Aged 18-55 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Conditions: Attention-Deficit/Hyperactivity Disorder
Being tested: SPD489 (Lisdexamfetamine dimesylate), Placebo
Keywords: ADHD
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

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

SPD489 (Lisdexamfetamine dimesylate)Drug
Also called Vyvanse
1 capsule (either 30, 50, or 70mg strength) per day for 6 weeks.
PlaceboDrug
1 capsule (identical to drug capsules) per day for 4 weeks during the double blind period.

Study groups in NCT00877487
Study group	Role	What they receive
SPD489	Experimental	Not described Receives: Drug: SPD489 (Lisdexamfetamine dimesylate)
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Percent of Treatment Failures at up to 6 Weeks
Treatment failure defined as > or equal to 50% increase in the ADHD-RS with adult prompts total score and a > or equal to 2 point increase in the CGI-S score.
Measured: Up to 6 weeks

Secondary outcomes (2)

Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 6 Weeks
The ADHD-RS consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Measured: Up to 6 weeks
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Measured: Up to 6 weeks

Timeline

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

30 Apr 20098 Jul 2010

First posted7 Apr 2009 (estimated)
Study start30 Apr 2009
Primary completion8 Jul 2010
Study completion8 Jul 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 (2)Papers the sponsor has linked to this study.
Other trials for Attention-Deficit/Hyperactivity DisorderStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00877487
Sponsor's protocol ID: SPD489-401
Status last verified: Jun 2021
First submitted: 19 Mar 2009
Last updated: 22 Jun 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

Brams M, Weisler R, Findling RL, Gasior M, Hamdani M, Ferreira-Cornwell MC, Squires L. Maintenance of efficacy of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: randomized withdrawal design. J Clin Psychiatry. 2012 Jul;73(7):977-83. doi: 10.4088/JCP.11m07430. Epub 2012 Jun 12.
PubMed 22780921
Weisler RH, Babcock T, Adeyi B, Brams M. Relationship of ADHD symptoms and global illness severity in adults treated with lisdexamfetamine dimesylate. Postgrad Med. 2014 Sep;126(5):31-41. doi: 10.3810/pgm.2014.09.2798.
PubMed 25295648

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?

See locations

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Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
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All Attention-Deficit/Hyperactivity Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4, Double-Blind, Multi-Center, Placebo-Controlled, Randomized Withdrawal, Safety and Efficacy Study of SPD489 in Adults Aged 18-55 With Attention-Deficit/Hyperactivity Disorder (ADHD)
ClinicalTrials.gov ID: NCT00877487
Acronym / sponsor ID: SPD489-401
Conditions: Attention-Deficit/Hyperactivity Disorder
Keywords: ADHD
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 123 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 30 Apr 2009 (actual)
Primary completion: 8 Jul 2010 (actual)
Study completion: 8 Jul 2010 (actual)
First posted: 7 Apr 2009 (estimated)
Results: Posted 2 Aug 2011

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SPD489	Experimental	Drug: SPD489 (Lisdexamfetamine dimesylate)
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Subject must be 18-55 years of age, inclusive at the time of consent.
Female subjects must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at baseline and agree to comply with any applicable contraceptive requirements of the protocol.
Subject has a documented diagnosis of ADHD or meets DSM-IV-TR™ with adult prompts criteria by history for a primary diagnosis of ADHD prior to treatment.
Subject has a Baseline score of <22 using the Adult ADHD-RS with prompts and CGI-S score ≤3.
Subject has been on stable treatment with commercial SPD489 (30, 50, or 70mg) for a minimum of at least 6 months preceding the Screening Visit with acceptable tolerability.Prior treatment with commercial SPD489 in the 6 months preceding the Screening Visit must be documented by prescription records, prescribing physician notes, or pharmacy records. Those subjects whose primary care physician (PCP) is someone other than the Principal Investigator (PI) will be required to provide the above documentation to the site.

Key exclusion criteria (21 listed)

Subject has a current comorbid psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms. Prohibited disorders include those associated with diagnoses including but not limited to any severe comorbid Axis II disorder or severe Axis I disorder (such as Post Traumatic Stress Disorder [PTSD], psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder). Other symptomatic manifestations (such as agitated states)that contraindicate treatment with SPD489 or confound efficacy or safety assessments in the opinion of the examining physician are also prohibited. Comorbid psychiatric diagnoses will be established by the psychiatric evaluation that includes the Structured Clinical Interview for DSM-IV-TR™ disorders (SCID-I).
Subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently demonstrating suicidal ideation.
The subject has a body mass index (BMI) of <18.5 or ≥40.
Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Similarly, the subject will be excluded if he or she has any additional condition(s) that in the Investigator's opinion would prohibit the subject from completing the study or would not be in the best interest of the subject. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
Subject has a history of seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.

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
SPD489 (Lisdexamfetamine dimesylate)Also: Vyvanse1 capsule (either 30, 50, or 70mg strength) per day for 6 weeks.	Drug	SPD489
Placebo1 capsule (identical to drug capsules) per day for 4 weeks during the double blind period.	Drug	Placebo

Primary outcome

Percent of Treatment Failures at up to 6 Weeks
Time frame: Up to 6 weeks
Treatment failure defined as > or equal to 50% increase in the ADHD-RS with adult prompts total score and a > or equal to 2 point increase in the CGI-S score.

2 secondary outcomes

Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 6 Weeks
Time frame: Up to 6 weeks
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks
Time frame: Up to 6 weeks

Results and safety

Results posted to the registry on 2 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SPD489	123	116
Placebo	0	0

Primary outcome: Percent of Treatment Failures at up to 6 Weeks

Time frame: Up to 6 weeks. Number. Unit: Percent of participants

Measure	SPD489 n = 56	Placebo n = 60
Value	8.9	75.0

SPD489 vs Placebo: p <0.0001, Chi-squared

Population analysed: Full Analysis Set (FAS) defined as all subjects who were randomized and received at least 1 dose of investigational product.

2 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
SPD489	0 of 56 (0%)	16 of 56 (28.6%)	Not reported
Placebo	1 of 60 (1.7%)	6 of 60 (10%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22780921Brams M, Weisler R, Findling RL, Gasior M, Hamdani M, Ferreira-Cornwell MC, Squires L. Maintenance of efficacy of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: randomized withdrawal design. J Clin Psychiatry. 2012 Jul;73(7):977-83. doi: 10.4088/JCP.11m07430. Epub 2012 Jun 12.
Derived from this study: PubMed 25295648Weisler RH, Babcock T, Adeyi B, Brams M. Relationship of ADHD symptoms and global illness severity in adults treated with lisdexamfetamine dimesylate. Postgrad Med. 2014 Sep;126(5):31-41. doi: 10.3810/pgm.2014.09.2798.
FDA Recall InformationLink provided by the sponsor.

Related trials for Attention-Deficit/Hyperactivity Disorder

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD

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.

Study Director study director

Takeda

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing SPD489 (Lisdexamfetamine dimesylate) in people with Attention-Deficit/Hyperactivity Disorder, run by Shire at 55 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 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 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Aug 2011). 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?

Percent of Treatment Failures at up to 6 Weeks (time frame: Up to 6 weeks). 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 NCT00877487, which also lists 2 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 22 Jun 2021.