Tourette SyndromePhase 3NCT00206323
A Randomized, Placebo-controlled, Tourette Syndrome Study.
A Phase 3 study testing Topiramate (drug) in people with Tourette Syndrome, run by Baylor College of Medicine.
Trial summary
Previous studies using topiramate in Tourette subjects have shown that with the use of this medication subjects report that their tics get better. The purpose of this study is to study if topiramate improves the symptoms of Tourette syndrome, such as motor tics, or other associated symptoms such as attention or… Read more about this study
- Who is it for?
- Ages 7 to 65 years
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- Topiramate (drug)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Dec 2008
- 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 7 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must have a diagnosis of Tourette Syndrome for at least 3 months.
- Subjects must have a minimum Tic rating scale of > or equal to 19 (current symptoms excluding impairment) at Visit 1 (Day -10 through Day -7) and Visit 2 (Day ).
- Subjects must have a rating scale severity score of > or equal to 4 (moderately ill) at Visit 1 (Day -10 through Day -7) and Visit 2 (Day 1).
- Subjects must be between 7 and 65 years of age, inclusive.
- Subjects must be >25 kg (55 lbs).
- Subjects must be able to take oral medication in tablet form without crushing or otherwise altering the tablet, adhere to medication regimens and be willing to return for regular visits.
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- Subjects must have observed the designated washout periods for prohibited medications outlined under the Concomitant Therapy section of this protocol.
- Subjects must have a negative urine drug screening at Visit 1 (Day -7).
- Subjects must be in generally good health as confirmed by medical history, baseline psychiatric history and physical examination, including vital signs.
- Subjects must: a) be premenarchal, postmenopausal for at least one year, or b) have had a hysterectomy or tubal ligation or otherwise be incapable of pregnancy, or c) have practiced one of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide and barrier, intrauterine device, spousal/partner sterility or d) be practicing abstinence and agree to continue abstinence or to use an acceptable method of contraception (as listed above) should sexual activity commence. If (c) or (d), subjects must have a negative urine pregnancy test up to one week prior to Visit 2 (Day 1).
- Subjects, or their parents/guardians, must be able to read and comprehend written instructions and willing to complete all scales and inventories required by this protocol.
Who cannot join
- Subjects who have a diagnosis of substance dependence or abuse (with the exception of nicotine or caffeine dependence) within the past 3 months.
- Subjects with a significant and unstable major psychiatric disorder requiring treatment.
- Subjects with mental retardation.
- Subjects with progressive or degenerative neurological disorders or a structural disorder of the brain from birth, trauma or past infection.
- Subjects taking more than one agent for the treatment of tics, more than one agent for the treatment of comorbid symptoms or more than one agent for the treatment of ADHD and/or the dose of the current treatment has not been stable for a minimum of 6 weeks.
- Subjects who are pregnant or lactating.
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- Subjects with prior non-response to topiramate for the treatment of Tourette Syndrome following an adequate trial.
- Subjects with a history of nephrolithiasis.
- Subjects with an estimated creatinine clearance of <60 mL/min.
- Subjects who have Liver function levels greater than 2 times the upper limit of the normal range at Visit 1.
- Subjects who have active liver disease.
- Subjects who have previously been treated with topiramate and discontinued treatment due to an adverse event or subjects with a known hypersensitivity to topiramate.
- Subjects known to have clinically significant medical conditions, including, but not limited to: a) any unstable disease or condition, including cardiovascular, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease that could compromise the function of those body systems that could result in altered absorption, excess accumulation or impaired metabolism or excretion of topiramate or interfere with their participation in the study; b) malignancy or history of malignancy (excluding basal cell carcinoma) within the past 5 years; and c) subjects with a history of attempted suicide or suicidal tendencies or judged clinically to be at serious suicidal risk
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Safety and Efficacy of Topiramate in the Treatment of Tourette Syndrome (CAPSS-176)
Previous studies using topiramate in Tourette subjects have shown that with the use of this medication subjects report that their tics get better. The purpose of this study is to study if topiramate improves the symptoms of Tourette syndrome, such as motor tics, or other associated symptoms such as attention or obsessive-compulsive problems.
Read the detailed description
This study consists of three phases: Screening/Washout Phase, Double-Blind Phase and Taper Phase.
SCREENING/WASHOUT PHASE: Your study doctor or his staff will review with you any medications that you are currently taking and may instruct you, if appropriate, to discontinue taking certain medications. Your study doctor or his staff will explain how long you need to stop taking each drug before you can start the study. Depending on the type of medications you may be taking, the Screening/Washout Visit (Visit 1 of the study) may have to be completed in two visits. The screening/washout phase may take up to 90 days. If you agree to participate, the study doctor or his staff will carry out tests to see if you are eligible for this study. At the Screening/Washout Visit, you will have a medical and psychiatric history review (including medications you have taken for treating Tourette Syndrome) and a physical examination (including sitting blood pressure, pulse, temperature, weight and height). A blood sample will be taken (approximately 2-3 teaspoons) and tested to rule out any abnormalities. You will be asked to give a urine sample that will be tested for drug use and, if you are a female that is capable of having a child, to ensure that you are not pregnant at the time of study entry. The pregnancy test must be negative for you to continue in the study. Additionally, you may not currently be breastfeeding to continue in the study. You will undergo a medical and psychiatric evaluation. You will be asked to answer questions using scales, including one that measures the severity of your symptoms of Tourette Syndrome and one that measures your symptoms, if any, of attention deficit hyperactivity disorder (A-D/HD).
TITRATION/MAINTANENCE PHASE: If you continue to qualify for the study after the Visit 1 tests have been reviewed by the study doctor or his staff and you have completed the washout phase, you will return to your study doctor's office for Visit 2. The length of time between Visit 1 and Visit 2 will depend on the kind of medications you are taking (and may need to stop before entering this study). At Visit 2, you will have your blood pressure, pulse and weight measured. You will be asked to answer questions for the same two scales that you completed at Visit 1. You are asked to return all medication bottles (even if empty, partially used or unused) to each study visit. It is very important for us to be able to check study drug compliance.
You will be asked questions about how you are feeling and if you have started taking any new medications or had changes in other medications you may be taking since your last visit.
If you continue to meet eligibility requirements for the study, you will enter the study. You will be assigned by chance to one of two treatment groups. You may receive either topiramate or placebo (an inactive substance). This makes the assessment of the study drug much fairer. The chances you are receiving the study drug versus placebo are 1 to 1 or equal (50% chance that you will receive topiramate and 50% chance that you will receive placebo).
The study will last approximately 10 weeks. You will begin the study by taking 1 tablet of study medication (topiramate 25 mg or placebo) in the evening. This will be Day 1 of the study. After one week of this phase of the study, your study medication dose will be increased to 2 tablets (topiramate 50 mg or placebo) one tablet in the morning and one in the evening. Your study medication dose may continue to be increased until you have reached the dose level the study doctor determines to be appropriate for you, or, you are taking a maximum dose of 200 mgs per day of study medication (topiramate or placebo). Your study doctor may adjust your study medication dose as necessary. Study medication will be provided in 25 mg tablets of topiramate or placebo. Medication is provided in child-resistant bottles. All bottles should be returned (regardless of whether they are partial, empty or full) at each visit. It is important that you follow your study doctor or his staff's instructions on when and how to take the study medication. You will be expected to visit your study doctor or his staff again on Day 28 (Visit 3), Day 56 (Visit 4) and Day 70 (Visit 5) after beginning treatment. At Visit 5 (Day 70), you will be given instructions about reducing your study medication gradually for the next week.
At each visit, you will have your blood pressure, pulse, temperature and weight measured. You will be asked how you are feeling and if you have started taking any new medications or had changes in other medications you may be taking. At Visits 3 and 5 you will be asked again to answer questions for all of the scales that you completed at Visit 2. At Visits 3, 4 and 5, the study doctor or his staff will complete the scale that assesses the severity of your condition. At Visits 3 and 5, the study doctor or his staff will complete one scale that assesses the severity of your Tourette Syndrome symptoms. At Visits 3, 4 and 5 you will have a urine pregnancy test performed again if you are a female capable of bearing a child. The test must be negative to continue in the study. You will have blood drawn again (approximately one teaspoon) at Visits 3 and 5 to make sure that your liver is functioning properly and that your electrolytes (blood chemistry measurements) are also within normal range. At Visit 5 you will have another physical examination.
You will be called weekly between Visits 2 and 3 (Days 7, 14 and Day 21 of the study) and Visits 3 and 4 (Days 35 and 42 of the study) on the telephone by one of the people working on this study. During these phone calls you will be asked how you are feeling, if you have had any changes in medications you are taking and how you are doing with the study medication.
TAPER PHASE: You will visit the study doctor or his staff again on Day 77 (Visit 6) after you have completely stopped taking the study medication. You must keep all medication packaging and any unused medication, and bring it back to the study doctor or his staff at each visit. At this visit, you will have your blood pressure and pulse taken and your weight measured. You will be asked again to answer questions for the scale that measures the severity of your symptoms of Tourette Syndrome. If you are a female capable of bearing a child, a urine pregnancy test will be performed. You will be asked how you are feeling and if you have started taking any new medications or had changes in other medications you may be taking.
Joseph Jankovic, Joohi Jimenez-Shahed and Lawrence Brown J. Neurol. Neurosurg. Psychiatry published online 1 Sep 2009; doi:10.1136/jnnp.2009.185348
- Conditions
- Tourette Syndrome
- Being tested
- Topiramate (drug), placebo/sugar pill
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topiramate (drug)Drug
Also called Topamax
Topiramate 25 mg titrated to 200 mg
placebo/sugar pillDrug
Also called placebo
placebo
| Study group | Role | What they receive |
|---|---|---|
| placebo/sugar pill | Placebo comparator | Placebo or sugar pill Receives: Drug: placebo/sugar pill |
| Topiramate | Active comparator | Topiramate 25 mg to 200 mg Receives: Drug: Topiramate (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total Tic Score at Day 70
A component of the Yale Global Tic Severity Scale (YGTSS), the change from baseline in Total Tic Score (TTS) at visit 5 (day 70) is the pre-defined primary endpoint.
The Total Tic Score (TTS) is a summation of the Total Motor Tic and Total Phonic Tic Scores. The Overall Impairment Rating is rated on a 50-point scale anchored by 0 (No impairment) and 50 (Severe impairment).
Measured: baseline and Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionDec 2008
- Study completionDec 2008
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 Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Responsible party
- Principal investigator, Joseph Jankovic, Baylor College of Medicine
- Investigators
- Joseph Jankovic, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206323
- Sponsor's protocol ID
- H-13552
- Status last verified
- Jan 2020
- First submitted
- 13 Sep 2005
- Last updated
- 12 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jankovic J, Jimenez-Shahed J, Brown LW. A randomised, double-blind, placebo-controlled study of topiramate in the treatment of Tourette syndrome. J Neurol Neurosurg Psychiatry. 2010 Jan;81(1):70-3. doi: 10.1136/jnnp.2009.185348. Epub 2009 Sep 1.
PubMed 19726418
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Safety and Efficacy of Topiramate in the Treatment of Tourette Syndrome (CAPSS-176)
- ClinicalTrials.gov ID
- NCT00206323
- Acronym / sponsor ID
- H-13552
- Conditions
- Tourette Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Study start
- Sep 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 6 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies using topiramate in Tourette subjects have shown that with the use of this medication subjects report that their tics get better. The purpose of this study is to study if topiramate improves the symptoms of Tourette syndrome, such as motor tics, or other associated symptoms such as attention or obsessive-compulsive problems.
Detailed description
This study consists of three phases: Screening/Washout Phase, Double-Blind Phase and Taper Phase.
SCREENING/WASHOUT PHASE: Your study doctor or his staff will review with you any medications that you are currently taking and may instruct you, if appropriate, to discontinue taking certain medications. Your study doctor or his staff will explain how long you need to stop taking each drug before you can start the study. Depending on the type of medications you may be taking, the Screening/Washout Visit (Visit 1 of the study) may have to be completed in two visits. The screening/washout phase may take up to 90 days. If you agree to participate, the study doctor or his staff will carry out tests to see if you are eligible for this study. At the Screening/Washout Visit, you will have a medical and psychiatric history review (including medications you have taken for treating Tourette Syndrome) and a physical examination (including sitting blood pressure, pulse, temperature, weight and height). A blood sample will be taken (approximately 2-3 teaspoons) and tested to rule out any abnormalities. You will be asked to give a urine sample that will be tested for drug use and, if you are a female that is capable of having a child, to ensure that you are not pregnant at the time of study entry. The pregnancy test must be negative for you to continue in the study. Additionally, you may not currently be breastfeeding to continue in the study. You will undergo a medical and psychiatric evaluation. You will be asked to answer questions using scales, including one that measures the severity of your symptoms of Tourette Syndrome and one that measures your symptoms, if any, of attention deficit hyperactivity disorder (A-D/HD).
TITRATION/MAINTANENCE PHASE: If you continue to qualify for the study after the Visit 1 tests have been reviewed by the study doctor or his staff and you have completed the washout phase, you will return to your study doctor's office for Visit 2. The length of time between Visit 1 and Visit 2 will depend on the kind of medications you are taking (and may need to stop before entering this study). At Visit 2, you will have your blood pressure, pulse and weight measured. You will be asked to answer questions for the same two scales that you completed at Visit 1. You are asked to return all medication bottles (even if empty, partially used or unused) to each study visit. It is very important for us to be able to check study drug compliance.
You will be asked questions about how you are feeling and if you have started taking any new medications or had changes in other medications you may be taking since your last visit.
If you continue to meet eligibility requirements for the study, you will enter the study. You will be assigned by chance to one of two treatment groups. You may receive either topiramate or placebo (an inactive substance). This makes the assessment of the study drug much fairer. The chances you are receiving the study drug versus placebo are 1 to 1 or equal (50% chance that you will receive topiramate and 50% chance that you will receive placebo).
The study will last approximately 10 weeks. You will begin the study by taking 1 tablet of study medication (topiramate 25 mg or placebo) in the evening. This will be Day 1 of the study. After one week of this phase of the study, your study medication dose will be increased to 2 tablets (topiramate 50 mg or placebo) one tablet in the morning and one in the evening. Your study medication dose may continue to be increased until you have reached the dose level the study doctor determines to be appropriate for you, or, you are taking a maximum dose of 200 mgs per day of study medication (topiramate or placebo). Your study doctor may adjust your study medication dose as necessary. Study medication will be provided in 25 mg tablets of topiramate or placebo. Medication is provided in child-resistant bottles. All bottles should be returned (regardless of whether they are partial, empty or full) at each visit. It is important that you follow your study doctor or his staff's instructions on when and how to take the study medication. You will be expected to visit your study doctor or his staff again on Day 28 (Visit 3), Day 56 (Visit 4) and Day 70 (Visit 5) after beginning treatment. At Visit 5 (Day 70), you will be given instructions about reducing your study medication gradually for the next week.
At each visit, you will have your blood pressure, pulse, temperature and weight measured. You will be asked how you are feeling and if you have started taking any new medications or had changes in other medications you may be taking. At Visits 3 and 5 you will be asked again to answer questions for all of the scales that you completed at Visit 2. At Visits 3, 4 and 5, the study doctor or his staff will complete the scale that assesses the severity of your condition. At Visits 3 and 5, the study doctor or his staff will complete one scale that assesses the severity of your Tourette Syndrome symptoms. At Visits 3, 4 and 5 you will have a urine pregnancy test performed again if you are a female capable of bearing a child. The test must be negative to continue in the study. You will have blood drawn again (approximately one teaspoon) at Visits 3 and 5 to make sure that your liver is functioning properly and that your electrolytes (blood chemistry measurements) are also within normal range. At Visit 5 you will have another physical examination.
You will be called weekly between Visits 2 and 3 (Days 7, 14 and Day 21 of the study) and Visits 3 and 4 (Days 35 and 42 of the study) on the telephone by one of the people working on this study. During these phone calls you will be asked how you are feeling, if you have had any changes in medications you are taking and how you are doing with the study medication.
TAPER PHASE: You will visit the study doctor or his staff again on Day 77 (Visit 6) after you have completely stopped taking the study medication. You must keep all medication packaging and any unused medication, and bring it back to the study doctor or his staff at each visit. At this visit, you will have your blood pressure and pulse taken and your weight measured. You will be asked again to answer questions for the scale that measures the severity of your symptoms of Tourette Syndrome. If you are a female capable of bearing a child, a urine pregnancy test will be performed. You will be asked how you are feeling and if you have started taking any new medications or had changes in other medications you may be taking.
Joseph Jankovic, Joohi Jimenez-Shahed and Lawrence Brown J. Neurol. Neurosurg. Psychiatry published online 1 Sep 2009; doi:10.1136/jnnp.2009.185348
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/sugar pill | Placebo comparator | Drug: placebo/sugar pillPlacebo or sugar pill |
| Topiramate | Active comparator | Drug: Topiramate (drug)Topiramate 25 mg to 200 mg |
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must have a diagnosis of Tourette Syndrome for at least 3 months.
- Subjects must have a minimum Tic rating scale of > or equal to 19 (current symptoms excluding impairment) at Visit 1 (Day -10 through Day -7) and Visit 2 (Day ).
- Subjects must have a rating scale severity score of > or equal to 4 (moderately ill) at Visit 1 (Day -10 through Day -7) and Visit 2 (Day 1).
- Subjects must be between 7 and 65 years of age, inclusive.
- Subjects must be >25 kg (55 lbs).
Key exclusion criteria (13 listed)
- Subjects who have a diagnosis of substance dependence or abuse (with the exception of nicotine or caffeine dependence) within the past 3 months.
- Subjects with a significant and unstable major psychiatric disorder requiring treatment.
- Subjects with mental retardation.
- Subjects with progressive or degenerative neurological disorders or a structural disorder of the brain from birth, trauma or past infection.
- Subjects taking more than one agent for the treatment of tics, more than one agent for the treatment of comorbid symptoms or more than one agent for the treatment of ADHD and/or the dose of the current treatment has not been stable for a minimum of 6 weeks.
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 |
|---|---|---|
| Topiramate (drug)Also: TopamaxTopiramate 25 mg titrated to 200 mg | Drug | Topiramate |
| placebo/sugar pillAlso: placeboplacebo | Drug | placebo/sugar pill |
Primary outcome
Change From Baseline in Total Tic Score at Day 70
Time frame: baseline and Day 70
A component of the Yale Global Tic Severity Scale (YGTSS), the change from baseline in Total Tic Score (TTS) at visit 5 (day 70) is the pre-defined primary endpoint. The Total Tic Score (TTS) is a summation of the Total Motor Tic and Total Phonic Tic Scores. The Overall Impairment Rating is rated on a 50-point scale anchored by 0 (No impairment) and 50 (Severe impairment).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19726418Jankovic J, Jimenez-Shahed J, Brown LW. A randomised, double-blind, placebo-controlled study of topiramate in the treatment of Tourette syndrome. J Neurol Neurosurg Psychiatry. 2010 Jan;81(1):70-3. doi: 10.1136/jnnp.2009.185348. Epub 2009 Sep 1.
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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.
Joseph Jankovic, MD principal investigator
Baylor College of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topiramate (drug) in people with Tourette Syndrome, run by Baylor College of Medicine.
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 11 inclusion and 13 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 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 6 Nov 2017). 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?
Change From Baseline in Total Tic Score at Day 70 (time frame: baseline and Day 70). 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 NCT00206323, 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 12 Feb 2020.