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SchizophreniaPhase 3ASPIRENCT00731549

Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia

A Phase 3 study testing Aripiprazole IM Depot in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 214 sites in 28 countries.

Completed

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

Official record
Search all trials

Trial summary

To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance treatment in patients with schizophrenia. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
Aripiprazole IM Depot
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,081 participants
Where
214 sitesin 28 countries
Study dates
Dec 2008to Nov 2013
Phase
Phase 3
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as require by IRB/IEC), prior to the initiation of any protocol-required procedures.
  • Male and female subjects 18 to 65 years of age, inclusive, at time of informed consent.
  • Subjects who complete Studies 246/247 or who withdrew from the double-blind maintenance phase of either study (Phase 4 of Study 246 or Phase 3 of Study 247), or new subjects not participating in Studies 246/247.
  • # Subjects who, in the investigator's judgment, require chronic treatment with an antipsychotic medication.
  • Subjects able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, IM depot injection, discontinuation of prohibited concomitant medications, who can read and understand the written word in order to complete patient-reported outcomes measures, and who can be reliably rated on assessment scales.

Who cannot join

  • Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder.
  • Subjects with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history or response only to clozapine.
  • Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's judgment.
  • Subjects who currently meet DSM-IV-TR criteria for substance dependence; including alcohol and benzodiazepines, but excluding caffeine and nicotine, or two positive drug screens for cocaine.
  • Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
  • Subjects with a history of hypersensitivity to antipsychotic agents.
  • Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.

Trial locations and contacts

214 sites in 28 countries.

214 sites in 28 countries

United States96 sites

  • Study site

    Albuquerque, New Mexico, 87131

  • Study site

    Allentown, Pennsylvania, 18104

  • Study site

    Anaheim, California, 92804

  • Study site

    Atlanta, Georgia, 30328

  • Study site

    Austin, Texas, 78731

  • Study site

    Austin, Texas, 78754

  • Study site

    Baton Rouge, Louisiana, 70808

  • Study site

    Baton Rouge, Louisiana, 70809

  • Study site

    Bellevue, Washington, 98007

  • Study site

    Bothell, Washington, 98011

  • Study site

    Bradenton, Florida, 34208

  • Study site

    Buffalo, New York, 14213

  • Study site

    Buffalo, New York, 14215

  • Study site

    Canton, Ohio, 44718

  • Study site

    Cedarhurst, New York, 11516

  • Study site

    Cerritos, California, 90703

  • Study site

    Chandler, Arizona, 85226

  • Study site

    Charleston, South Carolina, 29401

  • Study site

    Charleston, South Carolina, 29407

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Chicago, Illinois, 60640

  • Study site

    Chino, California, 91710

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cleveland, Ohio, 44109

  • Study site

    Columbia, Maryland, 21045

  • Study site

    Coral Springs, Florida, 33065

  • Study site

    DeSoto, Texas, 75115

  • Study site

    Doral, Florida, 33166

  • Study site

    Escondido, California, 92025

  • Study site

    Flowood, Mississippi, 39232

  • Study site

    Gainesville, Florida, 32606

  • Study site

    Garden Grove, California, 92845

  • Study site

    Garfield Heights, Ohio, 44125

  • Study site

    Glendale, California, 91204

  • Study site

    Glendale, California, 91206

  • Study site

    Hickory, North Carolina, 28601

  • Study site

    Highlands Ranch, Colorado, 80130

  • Study site

    Hoffman Estates, Illinois, 60169

  • Study site

    Holliswood, New York, 11423

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Imperial, California, 92251

  • Study site

    Indianapolis, Indiana, 46222

  • Study site

    Jamaica, New York, 11418

  • Study site

    Jenkintown, Pennsylvania, 19046

  • Study site

    Johnson City, Tennessee, 37614-1707

  • Study site

    Kansas City, Missouri, 64108

  • Study site

    Kissimmee, Florida, 34741

  • Study site

    La Habra, California, 90631

  • Study site

    Lake Charles, Louisiana, 70629

  • Study site

    Los Angeles, California, 90024

  • Study site

    Maitland, Florida, 32751

  • Study site

    Media, Pennsylvania, 19063

  • Study site

    Memphis, Tennessee, 38119

  • Study site

    Miami, Florida, 33135

  • Study site

    Middleburg Heights, Ohio, 44130

  • Study site

    Milwaukee, Wisconsin, 53226

  • Study site

    Nashville, Tennessee, 37212

  • Study site

    National City, California, 91950

  • Study site

    New Orleans, Louisiana, 70115

  • Study site

    New York, New York, 10003

  • Study site

    New York, New York, 10027

  • Study site

    North Platte, Nebraska, 69101

  • Study site

    Norwalk, Connecticut, 06851

  • Study site

    Oak Brook, Illinois, 60523

  • Study site

    Oceanside, California, 92056

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Oklahoma City, Oklahoma, 73139

  • Study site

    Orange, California, 92868

  • Study site

    Orange City, Florida, 32763

  • Study site

    Orlando, Florida, 32839

  • Study site

    Pasadena, California, 91106

  • Study site

    Philadelphia, Pennsylvania, 19131

  • Study site

    Philadelphia, Pennsylvania, 19139

  • Study site

    Pico Rivera, California, 90660

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Plantation, Florida, 33317

  • Study site

    Richmond, Virginia, 23230

  • Study site

    Rochester, New York, 14615

  • Study site

    San Bernardino, California, 92408

  • Study site

    San Diego, California, 92102

  • Study site

    San Diego, California, 92103

  • Study Site

    San Diego, California, 92123

  • Study site

    San Diego, California, 92123

  • Study site

    Sellersville, Pennsylvania, 18960

  • Study site

    Sherman Oaks, California, 91403

  • Study site

    Shreveport, Louisiana, 71101

  • Study site

    Spokane, Washington, 99204

  • Study site

    St Louis, Missouri, 63109

  • Study site

    St Louis, Missouri, 63118

  • Study site

    Tampa, Florida, 33613

  • Study site

    Toledo, Ohio, 43609

  • Study site

    Torrance, California, 90502

  • Study site

    Washington D.C., District of Columbia, 20016

  • Study site

    Winston-Salem, North Carolina, 27104

Other trials in United States

Bulgaria12 sites

  • Study site

    Burgas, 8000

  • Study site

    Lovech, 5500

  • Study site

    Pazardzhik, 4400

  • Study site

    Pleven, 5800

  • Study site

    Plovdiv, 4002

  • Study site

    Radnevo, 6260

  • Study site

    Rousse, 7003

  • Study site

    Sofia, 1113

  • Study site

    Sofia, 1431

  • Study site

    Sofia, 1632

  • Study site

    Varna, 9001

  • Study site

    Veliko Tarnovo, 5007

Other trials in Bulgaria

Poland9 sites

  • Study site

    Bełchatów, 97-400

  • Study site

    Bialystok, 15-879

  • Study site

    Bydgoszcz, 85096

  • Study site

    Choroszcz, 16-070

  • Study site

    Krakow, 31-501

  • Study site

    Leszno, 64-100

  • Study site

    Pruszków, 05-802

  • Study site

    Sosnowiec, 41-200

  • Study site

    Wroclaw, 50-227

Other trials in Poland

Russia9 sites

  • Study site

    Lipetsk, 398007

  • Study site

    Moscow, 115522

  • Study site

    Moscow, 127083

  • Study site

    Nizhny Novgorod, 603152

  • Study site

    Nizhny Novgorod, 603155

  • Study site

    Saint Petersburg, 188357

  • Study site

    Saint Petersburg, 190121

  • Study site

    Saint Petersburg, 192019

  • Study site

    Smolensk, 214019

Other trials in Russia

Chile7 sites

  • Study site

    San Bernardo, Santiago, 8780000

  • Study site

    Santiago, 7500710

  • Study site

    Santiago, 7510186

  • Study site

    Santiago, 7580307

  • Study site

    Santiago, 8330838

  • Study site

    Santiago, 8900085

  • Study site

    Santiago

Other trials in Chile

India7 sites

  • Study site

    Ahmedabad, Gujarat, 380006

  • Study site

    Bangalore, Karnataka, 560010

  • Study site

    Chennai, Tamil Nadu, 600003

  • Study site

    Kanpur, 208005

  • Study site

    Mangalore, 575018

  • Study site

    Pune, 411004

  • Study site

    Tirupati, 517507

Other trials in India

South Korea7 sites

  • Study site

    Busan, 614-735

  • Study site

    Deajeon, 301-721

  • Study site

    Gwangju, 501-757

  • Study site

    Joong-gu, Incheon, 400-700

  • Study site

    Seoul, 110-744

  • Study site

    Seoul, 137-701

  • Study site

    Seoul, 150-950

Other trials in South Korea

Argentina6 sites

  • Study site

    Buenos Aires, C1058AAJ

  • Study site

    Buenos Aires, C1405BOA

  • Study site

    Buenos Aires, C1425AHQ

  • Study site

    Cordoba, Cordoba, X5009BIN

  • Study site

    La Plata, Buenos Aires

  • Study site

    Mendoza, 5500HYF

Other trials in Argentina

Australia6 sites

  • Study site

    Dandenong, Victoria, 3175

  • Study site

    Epping, Victoria, 3076

  • Study site

    Frankston, Victoria, 3199

  • Study site

    Fremantle, Western Australia, 6959

  • Study site

    Glenside, SA, 5063

  • Study site

    Melbourne, VIC 3004

Other trials in Australia

Romania6 sites

  • Study site

    Arad, 310022

  • Study site

    Bucharest, 041914

  • Study site

    Cluj-Napoca, 400012

  • Study site

    Craiova, 200620

  • Study site

    Oradea, 410154

  • Study site

    Piteşti, 110069

Other trials in Romania

Mexico5 sites

  • Study site

    Culiacán, Sinaloa, 80020

  • Study site

    Guadalajara, Jalisco, 44280

  • Study site

    Mexico City, Mexico City, 6700

  • Study site

    Monterrey, Nuevo León, 64040

  • Study site

    San Luis Potosí City, San Luis Potosí, 78218

Other trials in Mexico

Slovakia5 sites

  • Study site

    Košice, 041 90

  • Study site

    Liptovský Mikuláš, 3101

  • Study site

    Prešov, 8001

  • Study site

    Rimavská Sobota, 97901

  • Study site

    Svidník, 089 01

Other trials in Slovakia

Estonia4 sites

  • Study site

    Jämejala, 71024

  • Study site

    Tallinn, 10614

  • Study site

    Tallinn, 10617

  • Study site

    Tartu, 50406

Other trials in Estonia

Hungary4 sites

  • Study site

    Baja, 6500

  • Study site

    Balassagyarmat, 2660

  • Study site

    Cegléd, 2700

  • Study site

    Győr, 9023

Other trials in Hungary

Malaysia4 sites

  • Study site

    Kuala Lumpur, Kuala Lumpur, 50603

  • Study site

    Kuala Lumpur, Kuala Lumpur, 56000

  • Study site

    Kuala Selangor, 43000

  • Study site

    Tanjong Rambutan, Perak, 31250

Other trials in Malaysia

Philippines4 sites

  • Study site

    Bataan, Central Luzon, 2105

  • Study site

    Iloilo City, Western Visayas, 5000

  • Study site

    Mandaluyong, NCR, 1553

  • Study site

    Quezon City, NCR, 1104

Other trials in Philippines

France3 sites

  • Study site

    Élancourt, 78990

  • Study site

    Rennes, 35703

  • Study site

    Saint-Nazaire, 44606

Other trials in France

Spain3 sites

  • Study site

    Barcelona, 08036

  • Study site

    Barcelona, 08907

  • Study site

    Barcelona, 8005

Other trials in Spain

Thailand3 sites

  • Study site

    Bangkok, 10330

  • Study site

    Muang, Chiangmai, 50100

  • Study site

    Muang, Chiangmai, 50200

Other trials in Thailand

Croatia2 sites

  • Study site

    Zagreb, 10 090

  • Study site

    Zagreb, 10000

Other trials in Croatia

Norway2 sites

  • Study site

    Ålesund, 6018

  • Study site

    Klepp stasjon, 4353

Other trials in Norway

Serbia2 sites

  • Study site

    Belgrade, 11000

  • Study site

    Kragujevac, 34000

Other trials in Serbia

South Africa2 sites

  • Study site

    Cape Town, Western Province, 7530

  • Study site

    Pretoria, Gauteng, 0001

Other trials in South Africa

Taiwan2 sites

  • Study site

    Tainan, 704

  • Study site

    Taipei, 11086

Other trials in Taiwan

Austria1 site

  • Study site

    Innsbruck, A-6020

Other trials in Austria

Belgium1 site

  • Study site

    Bruges, 8200

Other trials in Belgium

Finland1 site

  • Study site

    Helsinki, 00250

Other trials in Finland

Puerto Rico1 site

  • Study site

    San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients With Schizophrenia

To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance treatment in patients with schizophrenia.

Read the detailed description

This will be an open-label, uncontrolled study which will enroll subjects from Phase 4 of Study 31-07-246 and Phase 3 of Study 31- 07-247 and new subjects not participating in Studies 246/247. The treatment history of subjects prior to enrollment in the open-label study will vary according to the design of the pivotal double-blind study (i.e., 31-07-246 or 31-07-247).

This open-label study will be comprised of phases similar to the pivotal double-blind studies (i.e., Studies 246/247): a screening phase (if applicable), a conversion phase (Phase 1, if applicable), an oral stabilization phase (Phase 2), and an IM depot open-label maintenance phase (Phase 3). Phase 3 will be a 52-week treatment period with a 26-week follow-up period.

During Phase 3 (the open-label maintenance phase) oral aripiprazole rescue medication will be allowed for subjects who do not meet stability criteria or meet the criteria for impending relapse/exacerbation of psychotic symptoms.

Conditions
Schizophrenia
Being tested
Aripiprazole IM Depot
Keywords
Aripiprazole, IM Depot, Schizophrenia, Intramuscular
Medical subject headings
Schizophrenia

What participants receive

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

  • Aripiprazole IM DepotDrug

    Also called Oral Aripiprazole

    300mg or 400mg

Study groups in NCT00731549
Study groupRoleWhat they receive
1ExperimentalActive Treatment of aripiprazole IM depot (300mg or 400mg)
Receives: Drug: Aripiprazole IM Depot

What is being measured

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

  1. Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit).

    "Stable" was defined as meeting all of the following criteria: Outpatient status; Positive and negative syndrome scale (PANSS) total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at endpoint (last visit) is described here.

    Measured: Baseline to Week 52/Last visit

Secondary outcomes (9)

  1. Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.

    "Impending relapse criteria" was defined as meeting all the following criteria: 1) Clinical Global Impression of Improvement (CGI-I) ≥ 5 (minimally worse), AND an increase to score of >4 and absolute increase of ≥ 2 on the individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content); or an increase to score >4 and absolute increase of ≥ 4 on the combined 4 PANSS items on any of these PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) OR 2) Hospitalization due to worsening of psychotic symptoms, but excluding hospitalization for psychosocial reasons, OR 3) CGI-SS score of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2, OR 4) Violent behavior resulting in clinically relevant self-injury, injury to another person, or property damage.

    Measured: Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48,52, and Last visit (upto 4 weeks ± 3 days after completion or withdrawal)

  2. Percentage of Participants Achieving Remission.

    Remission is defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of six months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, and lack of spontaneity.

    Measured: Overall remission from Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48 and 52

  3. Percentage of Participants Stable at Baseline and Remaining Stable at Week 28.

    "Stable" was defined as meeting all of the following criteria: Outpatient status; PANSS total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at Week 28 is described here.

    Measured: Baseline to Week 28

  4. Percentage of Participants With Time to First Exacerbation of Psychotic Symptoms/Impending Relapse.

    Participants who first time meet relapse criteria were considered as having an event at date of exacerbation of psychotic symptoms/impending relapse. Time to first event was calculated as the earliest date of meeting one of relapse criteria. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy.

    Measured: Baseline to Week 52

  5. Mean Change From Baseline to Endpoint (Last Visit) in Positive and Negative Syndrome Scale (PANSS) Total Score.

    PANSS total score (range 30-210) is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS scale. PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.

    Measured: Baseline, Weeks 12, 24, 52 and last visit

  6. Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score.

    To assess CGI-S, the rater or physician will answer the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.

    Measured: Baseline, Weeks 12, 24, 52 and last visit

  7. Mean Change From Baseline to Endpoint in PANSS Positive and Negative Subscales.

    PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. Positive subscale consists of 7 positive symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. Negative subscale consists of 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.

    Measured: Baseline, Weeks 12, 24, 52 and last visit

  8. Mean Clinical Global Impression of Improvement (CGI-I) Score.

    To assess CGI-I the rater or physician will rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses will be compared to the participants condition at baseline. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.

    Measured: Weeks 2, 4, 12, 24, 52 and last visit

  9. Percentage of Participants Who Discontinued Due to All Causes.

    Participants who discontinued due to any cause were noted. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy.

    Measured: Baseline to Week 52

Timeline

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

  1. First posted11 Aug 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,081 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00731549
Sponsor's protocol ID
31-08-248
Acronym
ASPIRE
Status last verified
Nov 2014
First submitted
5 Aug 2008
Last updated
26 Nov 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aripiprazole IM Depot in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 214 sites in 28 countries.

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 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 214 sites in United States, Bulgaria, Poland, Russia, Chile and 23 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 11 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit). (time frame: Baseline to Week 52/Last visit). 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 NCT00731549.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2014.

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