Parkinson's DiseasePhase 3NCT00449865
NET-PD LS-1 Creatine in Parkinson's Disease
A Phase 3 study testing creatine in people with Parkinson's Disease, run by University of Rochester at 50 sites in 2 countries.
Trial summary
The purpose of this trial is to determine if the nutritional supplement creatine slows the progression of Parkinson's disease over time. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- creatine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,741 participants
- Where
- 50 sitesin 2 countries
- Study dates
- Mar 2007to May 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Willing and able to give informed consent and willing to commit to long-term follow-up
- PD (asymmetric features including slowness (bradykinesia) plus resting tremor and/or rigidity) within 5 years of diagnosis
- Treated/responsive to dopaminergic therapy (dopamine agonists or levodopa) for at least 90 days, but not more than 2 years.
Who cannot join
- Use of creatine 14 days prior to baseline or during the study
- History of known hypersensitivity or intolerability to creatine
- Any unstable or clinically significant condition that would impair the subject's ability to comply with long term study follow-up
- Other know or suspected causes of parkinsonism (e.g. metabolic, drug induced, etc.), or any significant features suggestive of a diagnosis of atypical parkinsonism.
Trial locations and contacts
50 sites in 2 countries.
50 sites in 2 countries
United States48 sites
University Of Michigan, 1500 E Medical Center Drive, B1 H202 Nuclear Medicine,
Ann Arbor, Michigan, 48109-0028
Emory University, Wesley Woods Health Center, 1841 Clifton Road NE Room 328
Atlanta, Georgia, 30329
Medical College Of Georgia, Movement Disorders Clinic, 1429 Harper Street HF 1121
Augusta, Georgia, 30912
University Of Maryland School Of Medicine, Department Of Neurology, 22 South Greene Street N4W46
Baltimore, Maryland, 21201
Johns Hopkins University, 601 North Caroline Street, Suite 5064
Baltimore, Maryland, 21287-0875
University Of Alabama, Birmingham, 350 Sparks Center, 1720 7th Avenue South
Birmingham, Alabama, 35233
Brigham & Women's Hospital, Neurology Department ASB2, 75 Francis Street
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center, 330 Brookline Avenue Shapiro 809D
Boston, Massachusetts, 02215
SUNY Downstate Medical Center, 450 Clarkson Avenue, Department Of Neurology Box 1213
Brooklyn, New York, 11203-2098
University Of Vermont, Department Of Neurology , Given Building C-219, 89 Beaumont Avenue
Burlington, Vermont, 05405
Medical University Of South Carolina, Charleston Memorial Hospital, 326 Calhoun Street Suite 308
Charleston, South Carolina, 29401
University Of Virginia Neurology Fontaine, Department Of Neurology, 500 Ray C Hunt Drive
Charlottesville, Virginia, 22903
Northwestern University, 710 North Lake Shore Drive
Chicago, Illinois, 60611
Rush University Medical Center, Department Of Neurological Sciences, 1725 West Harrison Suite 755,
Chicago, Illinois, 60612
University Of Texas Southwestern Med Ctr. At Dallas, 5323 Harry Hines Boulevard H1-108
Dallas, Texas, 75390-9016
University Of Colorado Health Sciences Ctr, 4200 East 9th Avenue Campus Box C238, Department Of Clinical Pharmacy
Denver, Colorado, 80262
Duke University Medical Center, Duke Health Center At Morreene Road, 932 Morreene Road Room 213,
Durham, North Carolina, 27705
Michigan State University, Department Of Neurology A217 Clinical Center, 138 Service Road
East Lansing, Michigan, 48824
Parkinson's & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204,
Fountain Valley, California, 92708
VA Medical Center, 1601 Southwest Archer Road, Neurology Service (151)
Gainesville, Florida, 32608
University Of Florida, Mcknight Brain Institute, 100 South Newell Drive Room L3-100
Gainesville, Florida, 32610
Evanston Northwestern Healthcare, Department Of Neurology, 2100 Pfingsten Road Suite B110
Glenview, Illinois, 60026
Struthers Parkinson's Center, 6701 Country Club Drive,
Golden Valley, Minnesota, 55427
Pacific Health Research Institute, 405 North Kuakini Street, Suite 1011,
Honolulu, Hawaii, 96817
Baylor College Of Medicine, 6550 Fannin Suite 1801
Houston, Texas, 77030
Indiana University School Of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150
Indianapolis, Indiana, 46202
University Of Florida Jacksonville, 580 West 8th Street, Tower 1 8th Floor,
Jacksonville, Florida, 32209
University Of Kansas Medical Center, 3599 Rainbow Blvd, Department Of Neurology Mail Stop # 2012
Kansas City, Kansas, 66160-7314
Dartmouth Hitchcock Medical Center, One Medical Center Drive, 2 Buck Road
Lebanon, New Hampshire, 03756
University Of Kentucky Clinical Research, C201 Kentucky Clinic, 740 South Limestone Street
Lexington, Kentucky, 40536-0284
University Of Southern California, Healthcare Consultation Building II, 1520 San Pablo Street Suite 3000
Los Angeles, California, 90033
Northshore-LIJ Health System, The Feinstein Institute FPR Medical Research, 350 Community Drive Room,
Manhasset, New York, 11030
University Of Miami, 1501 North West 9th Avenue Second Floor, Department Of Neurology D4-5
Miami, Florida, 33136
Vanderbilt University Medical Center, 2311 Pierce Avenue, Room 2217,
Nashville, Tennessee, 37212
UMDNJ Robert Wood Johnson Medical School, Dept Of Neurology Suite 6100, 125 Paterson Street
New Brunswick, New Jersey, 08901
Neurodegenerative Disorders, 60 Temple Street Suite 8b
New Haven, Connecticut, 06510
Ochsner Clinic Foundation, 1514 Jefferson Highway, Dept. Of Neurology 7th Floor
New Orleans, Louisiana, 70121
Thomas Jefferson University, 1015 Chestnut Street Suite 520
Philadelphia, Pennsylvania, 19107
University of Pennsylvania; Pennsylvania Hospital, Penn Neurological Institute, 330 South Ninth Street
Philadelphia, Pennsylvania, 19107
Barrow Neurological Clinics At, St Joseph's Hospital & Medical Center, 500 West Thomas Road Suite 720,
Phoenix, Arizona, 85013
OHSU Oregon Health &Science University, Department Of Neurology, 3181 South West Sam Jackson Park Road
Portland, Oregon, 97239
University Of California San Francisco, Parkinson's Disease Clinic And Research Cen, 505 Parnassus Avenue M-798
San Francisco, California, 94143-0114
LSU Health Science Center Shreveport, 1501 Kings Highway, Room 3-436
Shreveport, Louisiana, 71130
Southern Illinois University School Of Medicine, PO Box 19645
Springfield, Illinois, 62794-9645
Washington University School Of Medicine, 660 South Euclid Avenue, Campus 8111,
St Louis, Missouri, 63110
The Parkinson's Institute, 675 Almanor Avenue
Sunnyvale, California, 94085
University Of South Florida, Movement Disorders Center, 5 Tampa General Circle Suite 410
Tampa, Florida, 33606
Thomas Jefferson University/Lankenau Hospital, Lankenau Medical Building Suite 161 East, 100 Lancaster Avenue
Wynnewood, Pennsylvania, 19096
Canada2 sites
University Of Calgary Movement Disorders Program, Dept Of Clin Neurosciences Area 3 Neurology, 3350 Hospital DR NW Health Sciences Centre
Calgary, Alberta, T2N4NI
University Of Alberta, 10230-111 Avenue Room 0601, Movement Disorders Clinic Glenrose Rehab Hospital
Edmonton, Alberta, T5G 0B7
About this study
Official title: A Multicenter, Double-Blind, Parallel Group, Placebo Controlled Study of Creatine in Subjects With Treated Parkinson's Disease (PD) Long Term Study (LS-1)
The purpose of this trial is to determine if the nutritional supplement creatine slows the progression of Parkinson's disease over time.
Read the detailed description
Parkinson's disease (PD) affects nearly a million Americans, a number that will increase over the coming decades as the population ages. Symptoms of PD may include tremor, rigidity or stiffness of the limbs and trunk, slowness of movement, and impaired balance and coordination. These problems occur because as PD worsens, some of the brain cells that control body movement die.
This study will determine if creatine--an investigational compound--is able to slow the progression of PD. Creatine, a widely used dietary supplement is thought to improve exercise performance. In animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells.
In the NET-PD LS-1 study, 1,720 participants will be randomly assigned to receive either creatine or a placebo (inactive substance). Participation in this study lasts a minimum of 5 years and includes at least 9 follow-up clinic visits and at least 3 telephone calls.
- Conditions
- Parkinson's Disease
- Being tested
- creatine, placebo
- Keywords
- Parkinson's disease, creatine, NET-PD, neuroprotection, PD
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
creatineDrug
Creatine, a widely used dietary supplement is thought to improve exercise performance. In animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells.
The study is comparing creatine 5 grams twice daily with placebo.
placeboOther
an inactive substance
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: placebo |
| creatine | Active comparator | Not described Receives: Drug: creatine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Global Outcome Combined Information on Change From Baseline in Schwab England Activities of Daily Living, 39-Item Parkinson's Disease Questionnaire, Ambulatory Capacity, Symbol Digit Modalities, and Modified Rankin at 5 Years.
All outcomes were coded such that higher scores indicated worse outcomes. Patients were ranked on each outcome and their ranks were summed (summed-ranks). Higher summed ranks (range, 5-4775) indicate worse outcomes. The mean summed ranks were compared by treatment group by a global statistical test (GST).
Measured: Change from baseline to 5 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionSep 2013
- Study completionMay 2014
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,741 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karl Kieburtz, University of Rochester
- Investigators
- Karl Kieburtz, MD, Principal investigator, Coordination CenterBarbara Tilley, PhD, Principal investigator, Statistics Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449865
- Sponsor's protocol ID
- U01NS43128 NET-PD
- Other IDs
- CRC, U01NS043128
- Status last verified
- Mar 2015
- First submitted
- 20 Mar 2007
- Last updated
- 2 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Leehey M, Luo S, Sharma S, Wills AA, Bainbridge JL, Wong PS, Simon DK, Schneider J, Zhang Y, Perez A, Dhall R, Christine CW, Singer C, Cambi F, Boyd JT. Association of metabolic syndrome and change in Unified Parkinson's Disease Rating Scale scores. Neurology. 2017 Oct 24;89(17):1789-1794. doi: 10.1212/WNL.0000000000004572. Epub 2017 Sep 29.
PubMed 28972194Wills AM, Li R, Perez A, Ren X, Boyd J; NINDS NET-PD Investigators. Predictors of weight loss in early treated Parkinson's disease from the NET-PD LS-1 cohort. J Neurol. 2017 Aug;264(8):1746-1753. doi: 10.1007/s00415-017-8562-4. Epub 2017 Jul 15.
PubMed 28712000Augustine EF, Dorsey ER, Hauser RA, Elm JJ, Tilley BC, Kieburtz KK. Communicating with participants during the conduct of multi-center clinical trials. Clin Trials. 2016 Dec;13(6):592-596. doi: 10.1177/1740774516665596. Epub 2016 Aug 29.
PubMed 27573636Wills AM, Perez A, Wang J, Su X, Morgan J, Rajan SS, Leehey MA, Pontone GM, Chou KL, Umeh C, Mari Z, Boyd J; NINDS Exploratory Trials in Parkinson Disease (NET-PD) Investigators. Association Between Change in Body Mass Index, Unified Parkinson's Disease Rating Scale Scores, and Survival Among Persons With Parkinson Disease: Secondary Analysis of Longitudinal Data From NINDS Exploratory Trials in Parkinson Disease Long-term Study 1. JAMA Neurol. 2016 Mar;73(3):321-8. doi: 10.1001/jamaneurol.2015.4265.
PubMed 26751506Writing Group for the NINDS Exploratory Trials in Parkinson Disease (NET-PD) Investigators; Kieburtz K, Tilley BC, Elm JJ, Babcock D, Hauser R, Ross GW, Augustine AH, Augustine EU, Aminoff MJ, Bodis-Wollner IG, Boyd J, Cambi F, Chou K, Christine CW, Cines M, Dahodwala N, Derwent L, Dewey RB Jr, Hawthorne K, Houghton DJ, Kamp C, Leehey M, Lew MF, Liang GS, Luo ST, Mari Z, Morgan JC, Parashos S, Perez A, Petrovitch H, Rajan S, Reichwein S, Roth JT, Schneider JS, Shannon KM, Simon DK, Simuni T, Singer C, Sudarsky L, Tanner CM, Umeh CC, Williams K, Wills AM. Effect of creatine monohydrate on clinical progression in patients with Parkinson disease: a randomized clinical trial. JAMA. 2015 Feb 10;313(6):584-93. doi: 10.1001/jama.2015.120.
PubMed 25668262
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Parallel Group, Placebo Controlled Study of Creatine in Subjects With Treated Parkinson's Disease (PD) Long Term Study (LS-1)
- ClinicalTrials.gov ID
- NCT00449865
- Acronym / sponsor ID
- U01NS43128 NET-PD
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, creatine, NET-PD, neuroprotection, PD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 1,741 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Mar 2007
- Primary completion
- Sep 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 21 Mar 2007 (estimated)
- Results
- Posted 2 Apr 2015
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 trial is to determine if the nutritional supplement creatine slows the progression of Parkinson's disease over time.
Detailed description
Parkinson's disease (PD) affects nearly a million Americans, a number that will increase over the coming decades as the population ages. Symptoms of PD may include tremor, rigidity or stiffness of the limbs and trunk, slowness of movement, and impaired balance and coordination. These problems occur because as PD worsens, some of the brain cells that control body movement die.
This study will determine if creatine--an investigational compound--is able to slow the progression of PD. Creatine, a widely used dietary supplement is thought to improve exercise performance. In animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells.
In the NET-PD LS-1 study, 1,720 participants will be randomly assigned to receive either creatine or a placebo (inactive substance). Participation in this study lasts a minimum of 5 years and includes at least 9 follow-up clinic visits and at least 3 telephone calls.
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 |
|---|---|---|
| Placebo | Placebo comparator | Other: placebo |
| creatine | Active comparator | Drug: creatine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Willing and able to give informed consent and willing to commit to long-term follow-up
- PD (asymmetric features including slowness (bradykinesia) plus resting tremor and/or rigidity) within 5 years of diagnosis
- Treated/responsive to dopaminergic therapy (dopamine agonists or levodopa) for at least 90 days, but not more than 2 years.
Key exclusion criteria (4 listed)
- Use of creatine 14 days prior to baseline or during the study
- History of known hypersensitivity or intolerability to creatine
- Any unstable or clinically significant condition that would impair the subject's ability to comply with long term study follow-up
- Other know or suspected causes of parkinsonism (e.g. metabolic, drug induced, etc.), or any significant features suggestive of a diagnosis of atypical parkinsonism.
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 |
|---|---|---|
| creatineCreatine, a widely used dietary supplement is thought to improve exercise performance. In animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells. The study is comparing creatine 5 grams twice daily with placebo. | Drug | creatine |
| placeboan inactive substance | Other | Placebo |
Primary outcome
The Global Outcome Combined Information on Change From Baseline in Schwab England Activities of Daily Living, 39-Item Parkinson's Disease Questionnaire, Ambulatory Capacity, Symbol Digit Modalities, and Modified Rankin at 5 Years.
Time frame: Change from baseline to 5 YEARS
All outcomes were coded such that higher scores indicated worse outcomes. Patients were ranked on each outcome and their ranks were summed (summed-ranks). Higher summed ranks (range, 5-4775) indicate worse outcomes. The mean summed ranks were compared by treatment group by a global statistical test (GST).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28972194Leehey M, Luo S, Sharma S, Wills AA, Bainbridge JL, Wong PS, Simon DK, Schneider J, Zhang Y, Perez A, Dhall R, Christine CW, Singer C, Cambi F, Boyd JT. Association of metabolic syndrome and change in Unified Parkinson's Disease Rating Scale scores. Neurology. 2017 Oct 24;89(17):1789-1794. doi: 10.1212/WNL.0000000000004572. Epub 2017 Sep 29.
- Derived from this study: PubMed 28712000Wills AM, Li R, Perez A, Ren X, Boyd J; NINDS NET-PD Investigators. Predictors of weight loss in early treated Parkinson's disease from the NET-PD LS-1 cohort. J Neurol. 2017 Aug;264(8):1746-1753. doi: 10.1007/s00415-017-8562-4. Epub 2017 Jul 15.
- Derived from this study: PubMed 27573636Augustine EF, Dorsey ER, Hauser RA, Elm JJ, Tilley BC, Kieburtz KK. Communicating with participants during the conduct of multi-center clinical trials. Clin Trials. 2016 Dec;13(6):592-596. doi: 10.1177/1740774516665596. Epub 2016 Aug 29.
- Derived from this study: PubMed 26751506Wills AM, Perez A, Wang J, Su X, Morgan J, Rajan SS, Leehey MA, Pontone GM, Chou KL, Umeh C, Mari Z, Boyd J; NINDS Exploratory Trials in Parkinson Disease (NET-PD) Investigators. Association Between Change in Body Mass Index, Unified Parkinson's Disease Rating Scale Scores, and Survival Among Persons With Parkinson Disease: Secondary Analysis of Longitudinal Data From NINDS Exploratory Trials in Parkinson Disease Long-term Study 1. JAMA Neurol. 2016 Mar;73(3):321-8. doi: 10.1001/jamaneurol.2015.4265.
- Derived from this study: PubMed 25668262Writing Group for the NINDS Exploratory Trials in Parkinson Disease (NET-PD) Investigators; Kieburtz K, Tilley BC, Elm JJ, Babcock D, Hauser R, Ross GW, Augustine AH, Augustine EU, Aminoff MJ, Bodis-Wollner IG, Boyd J, Cambi F, Chou K, Christine CW, Cines M, Dahodwala N, Derwent L, Dewey RB Jr, Hawthorne K, Houghton DJ, Kamp C, Leehey M, Lew MF, Liang GS, Luo ST, Mari Z, Morgan JC, Parashos S, Perez A, Petrovitch H, Rajan S, Reichwein S, Roth JT, Schneider JS, Shannon KM, Simon DK, Simuni T, Singer C, Sudarsky L, Tanner CM, Umeh CC, Williams K, Wills AM. Effect of creatine monohydrate on clinical progression in patients with Parkinson disease: a randomized clinical trial. JAMA. 2015 Feb 10;313(6):584-93. doi: 10.1001/jama.2015.120.
- NET PD websiteLink provided by the sponsor.
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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.
Karl Kieburtz, MD principal investigator
Coordination Center
Barbara Tilley, PhD principal investigator
Statistics Center
50 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing creatine in people with Parkinson's Disease, run by University of Rochester at 50 sites in 2 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 3 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: stopped early, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Canada. 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 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 2 Apr 2015). 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?
The Global Outcome Combined Information on Change From Baseline in Schwab England Activities of Daily Living, 39-Item Parkinson's Disease Questionnaire, Ambulatory Capacity, Symbol Digit Modalities, and Modified Rankin at 5 Years. (time frame: Change from baseline to 5 YEARS). 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 NCT00449865, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2015.