Attention Deficit/Hyperactivity DisorderPhase 4VBHRNCT00733356
The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading
A Phase 4 study testing Vyvanse in people with Attention Deficit/Hyperactivity Disorder, run by Kimberley Lakes at 1 site in United States.
Trial summary
This is a single-blind, Investigator Initiated study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension, over a… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit/Hyperactivity Disorder
- What is being tested?
- Vyvanse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Sep 2009
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Females of child-bearing potential must have a negative pregnancy test.
- Subjects must meet DSM-IV-TR™ criteria for a primary diagnosis of ADHD.
- Subjects must have an ADHDRS-IV-Parent: Inv total score at least 1.5 standard deviations above the age and gender norms.
- The subject is functioning at an age appropriate level intellectually as determined by an IQ score of ≥ 80 on the Kaufman Brief Intelligence Test.
- The subject and subject's parent or legal guardian must be willing and able to comply with all the testing and dosing requirements in this study.
- Subject has blood pressure measurements within the 95th percentile for age, gender, and height.
- All subjects and their parents must be able to communicate effectively in English with the doctor and his/her staff without the aid of an interpreter.
Who cannot join
- Subject has any documented, current, controlled psychiatric illness [except Oppositional Defiant Disorder (ODD)]. The child may continue participating in a behavior modification program during this study as long as he/she has been participating in the program for at least one month at the time of the baseline visit.
- Subject has Conduct Disorder (CD).
- Subject has a documented allergy, hypersensitivity or intolerance to amphetamines, which is the class of drug to which Vyvanse™ belongs.
- Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
- Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine).
- Subject had a history of seizures during the last two years (exclusive of febrile seizures), a tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
Show all 14Show fewer
- Subject has a history of heart abnormalities that the study doctor feels would exclude him/her from the study.
- Subject has a positive urine drug result at the screening visit.
- Subject weighs less than 50 pounds (22.7 kg).
- Subject has taken another investigational drug within the last 30 days prior to the screening visit.
- Subject has any reported history of abnormal thyroid function.
- Subject has any clinically significant electrocardiogram reading (an electrical recording of the heart - ECG) or laboratory abnormalities at the screening and/or baseline visits.
- The study doctor feels that the subject's safety would be jeopardized if entered in this study due to a current illness or medical condition. Mild, stable asthma is not exclusionary.
- Subject is taking any medication that is excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine Child Development Center
Irvine, California, 92697
About this study
This is a single-blind, Investigator Initiated study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension, over a period of approximately 6-8 weeks. Subjects will be between the ages of 6 and 12 at the beginning of the study.
Read the detailed description
This is a single-blind study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension over a period of approximately 6 weeks. Subjects will be between the ages of 6 and 12 at the beginning of the study.
The study will consist of periods detailed below:
Screening and Washout. Subjects will be screened up to four weeks prior to baseline. The washout period will be 3 days for most ADHD stimulant medication (the half life is around 3-5 hours and the washout is at least 5 half-lives in duration). Other medication will be discussed during the visit.
The Screening Visit will occur at the UCI Child Development Center and will allow for the determination of appropriateness of each subject's inclusion into the study. The Principal Investigator or his/her designee must obtain written signed and dated consent for the subject to participate in the study from the subject's parent(s)/legally authorized representative and assent must be given by the subject, prior to any study related procedures being performed. This visit is expected to last 3-4 hours and may take place across more than one day.
The following procedures will be conducted during the Screening Visit:
- Informed Consent/Assent obtained
- Psychiatric evaluation that utilizes the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version (K-SADS-PL) and according to DSM-IV-TR™ criteria
- Inclusion/Exclusion criteria confirmed
- Demographics collected
- Medical and Medication History
- Physical Examination including height (using a calibrated stadiometer), weight (using a calibrated scale)
- Sitting Vital Signs after 5 minutes of rest (oral or tympanic temperature, pulse, blood pressure, and respiratory rate)
- 12-Lead ECG after 5 minutes of rest
- Kaufman Brief Intelligence Test 2 (KBIT2): used to assess both verbal and non-verbal cognitive ability.
- Concomitant Medications reviewed
- Adverse Events reviewed
In addition, the subject will be asked to give a small blood sample, for safety screening purposes, for laboratory procedures (approximately 2 teaspoons).The following lab procedures will be performed:
- Hematology with complete blood count (CBC)
- Serum Chemistry
- Urinalysis and microscopic examination (if protein and/or blood are detected during urinalysis)
- Serum Pregnancy Test for all FOCP - A negative serum pregnancy test must be documented for inclusion into this study
- Urine drug test Baseline Procedures. After all Screening and washout procedures have been completed, subjects will return to the site for the Baseline Visit, which will last approximately 5-6 hours.
Subjects will be provided with a one-week supply of VyvanseTM 30mg/day. Subjects will begin treatment the morning of the baseline visit and continue on the same dose for the next week. The first dose of medication will be administered on site and subsequent dosing will be given to the subject's parent(s)/legally authorized representative who will be required to administer study drug to the subject upon awakening. During the visit subjects will perform the Attention Task while the NIRS is recording and they will also be given the Gray's Oral Reading Test before the medication is administered. After the medication is administered the subject will stay on site until the second NIRS measurement can be taken a second time. They will be provided food and activities during the waiting period.
The following procedures will be conducted during the Baseline Visit:
- Confirmation of continued eligibility (i.e., with respect to inclusion/exclusion criteria and medication history)
- Sitting Vital Signs (oral or tympanic temperature, pulse, blood pressure and respiratory rate)
- Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv): The primary efficacy measure, used to assess the 18 symptoms of ADHD.
- Clinical Global Impressions Severity scale (CGI-S): This measure is used to assess the severity of the subject's symptoms.
- Concomitant Medications will be reviewed with the subject.
- Adverse Events
- Medication administered on-site
- Near Infrared Spectroscopy and Attention Task performed twice, once at before medication and again 3-4 hours after first exposure to medication.
- Administer the Gray Oral Reading Test-4 (GORT-4), which used to test oral reading rate, accuracy, fluency, and comprehension, before exposure to medication.
- Distribute Open-Label Study Drug - A one-week supply of VyvanseTM 30mg capsules will be dispensed, including the dose administered on site.
Dose Optimization. During the dose optimization period, subjects will visit the office once per week so that the study doctor can determine if the subject is tolerating the study medication and if she/he is seeing any benefit. These visits will last approximately 45 minutes. The Investigator will review AEs, ADHD-RS-IV, and CGI-I scores, and use clinical judgment to ensure that subjects are titrated to an acceptable dose of VyvanseTM for evaluation.
The following procedures will be conducted at each dose optimization visit:
- Sitting Vital Signs (oral or tympanic temperature, pulse, blood pressure and respiratory rate)
- Subject Weight (using a calibrated scale)
- Investigator Dose Assessment
- ADHD-RS-IV
- Clinical Global Impressions Improvement Scale (CGI-I).
- Study Drug Accountability and Compliance Assessment Performed
- Distribute Open-Label Study Drug
- Concomitant Medications
- Adverse Events Dose Optimized NIRS and GORT Testing
This visit will be similar to the baseline visit. Subjects will arrive early in the morning and medication will be administered on-site. They will remain on site for the next 4 hours so that the dose will be at peak effect before administering the GORT or NIRS. The following procedures will happen during this visit:
- Sitting Vital Signs after 5 minutes of rest (oral and tympanic temperature, pulse, blood pressure and respiratory rate)
- Subject weight (using a calibrated scale)
- An electrocardiogram will be performed.
- Serum Pregnancy Test for all FOCP - A negative serum pregnancy test must be documented for the end of the study.
- ADHD-RS-IV
- CGI-I
- Study Drug Accountability and Compliance Assessment Performed
- Concomitant Medications
- Adverse Events
- Medication administered on-site
- Near Infrared Spectroscopy and Attention Task performed once.
- Administer the Gray's Oral Reading Test.
- Physical examination including height (using a calibrated stadiometer)
- 12 Lead ECG 30-day Follow-up Phone Call
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Being tested
- Vyvanse
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, ADD, reading, brain hemodynamics, brain imaging, attention, Near-Infrared Spectroscopy, NIRS, MSIT
- 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.
VyvanseDrug
Also called lisdexamfetamine dimesylate
Subjects will participate in an open-label dose optimization period and successful titration to an optimal dose of Vyvanse™, subjects will take their optimized dose of Vyvanse™ (30, 50 or 70 mg/day) during the week leading up to their final visit. During the study subjects will take their prescribed dose once a day in the morning with breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Vyvanse Treatment | Experimental | All subjects were tested at baseline before medication and then titrated to best dose and retested on Vyvanse Medication. Receives: Drug: Vyvanse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gray Oral Reading Rest, Fourth Edition (GORT-4)
The GORT-4 evaluates oral reading rate, accuracy and comprehension. Both Forms A and B were used.Half of the subjects randomly were tested on From A at baseline and the other half were tested with Form B.
The GORT-4 is a standardized measure/test. Scores provided are standard scores, which range from 1 to 20, with a Mean of 10 and Standard Deviation of 3. A higher score means better reading performance. There was no total score used or calculated in this study.
Measured: baseline and final day (lab school Assessments)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2009
- Study completionSep 2009
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 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kimberley Lakes
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Sponsor-investigator, Kimberley Lakes, University of California, Irvine
- Investigators
- Kimberley Lakes, PhD, Principal investigator, UC Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733356
- Sponsor's protocol ID
- VBHR
- Acronym
- VBHR
- Status last verified
- Jan 2018
- First submitted
- 11 Aug 2008
- Last updated
- 14 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wigal SB, Maltas S, Crinella F, Stehli A, Steinhoff K, Lakes K, Schuck S. Reading performance as a function of treatment with lisdexamfetamine dimesylate in elementary school children diagnosed with ADHD. J Atten Disord. 2012 Jan;16(1):23-33. doi: 10.1177/1087054710378008. Epub 2010 Oct 26.
PubMed 20978273
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading
- ClinicalTrials.gov ID
- NCT00733356
- Acronym / sponsor ID
- VBHR / VBHR
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, ADD, reading, brain hemodynamics, brain imaging, attention, Near-Infrared Spectroscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kimberley LakesUniversity, hospital or other
- Collaborators
- Shire
- Study start
- Jul 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 13 Aug 2008 (estimated)
- Results
- Posted 14 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-blind, Investigator Initiated study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension, over a period of approximately 6-8 weeks. Subjects will be between the ages of 6 and 12 at the beginning of the study.
Detailed description
This is a single-blind study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension over a period of approximately 6 weeks. Subjects will be between the ages of 6 and 12 at the beginning of the study.
The study will consist of periods detailed below:
Screening and Washout. Subjects will be screened up to four weeks prior to baseline. The washout period will be 3 days for most ADHD stimulant medication (the half life is around 3-5 hours and the washout is at least 5 half-lives in duration). Other medication will be discussed during the visit.
The Screening Visit will occur at the UCI Child Development Center and will allow for the determination of appropriateness of each subject's inclusion into the study. The Principal Investigator or his/her designee must obtain written signed and dated consent for the subject to participate in the study from the subject's parent(s)/legally authorized representative and assent must be given by the subject, prior to any study related procedures being performed. This visit is expected to last 3-4 hours and may take place across more than one day.
The following procedures will be conducted during the Screening Visit:
- Informed Consent/Assent obtained
- Psychiatric evaluation that utilizes the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version (K-SADS-PL) and according to DSM-IV-TR™ criteria
- Inclusion/Exclusion criteria confirmed
- Demographics collected
- Medical and Medication History
- Physical Examination including height (using a calibrated stadiometer), weight (using a calibrated scale)
- Sitting Vital Signs after 5 minutes of rest (oral or tympanic temperature, pulse, blood pressure, and respiratory rate)
- 12-Lead ECG after 5 minutes of rest
- Kaufman Brief Intelligence Test 2 (KBIT2): used to assess both verbal and non-verbal cognitive ability.
- Concomitant Medications reviewed
- Adverse Events reviewed
In addition, the subject will be asked to give a small blood sample, for safety screening purposes, for laboratory procedures (approximately 2 teaspoons).The following lab procedures will be performed:
- Hematology with complete blood count (CBC)
- Serum Chemistry
- Urinalysis and microscopic examination (if protein and/or blood are detected during urinalysis)
- Serum Pregnancy Test for all FOCP - A negative serum pregnancy test must be documented for inclusion into this study
- Urine drug test Baseline Procedures. After all Screening and washout procedures have been completed, subjects will return to the site for the Baseline Visit, which will last approximately 5-6 hours.
Subjects will be provided with a one-week supply of VyvanseTM 30mg/day. Subjects will begin treatment the morning of the baseline visit and continue on the same dose for the next week. The first dose of medication will be administered on site and subsequent dosing will be given to the subject's parent(s)/legally authorized representative who will be required to administer study drug to the subject upon awakening. During the visit subjects will perform the Attention Task while the NIRS is recording and they will also be given the Gray's Oral Reading Test before the medication is administered. After the medication is administered the subject will stay on site until the second NIRS measurement can be taken a second time. They will be provided food and activities during the waiting period.
The following procedures will be conducted during the Baseline Visit:
- Confirmation of continued eligibility (i.e., with respect to inclusion/exclusion criteria and medication history)
- Sitting Vital Signs (oral or tympanic temperature, pulse, blood pressure and respiratory rate)
- Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv): The primary efficacy measure, used to assess the 18 symptoms of ADHD.
- Clinical Global Impressions Severity scale (CGI-S): This measure is used to assess the severity of the subject's symptoms.
- Concomitant Medications will be reviewed with the subject.
- Adverse Events
- Medication administered on-site
- Near Infrared Spectroscopy and Attention Task performed twice, once at before medication and again 3-4 hours after first exposure to medication.
- Administer the Gray Oral Reading Test-4 (GORT-4), which used to test oral reading rate, accuracy, fluency, and comprehension, before exposure to medication.
- Distribute Open-Label Study Drug - A one-week supply of VyvanseTM 30mg capsules will be dispensed, including the dose administered on site.
Dose Optimization. During the dose optimization period, subjects will visit the office once per week so that the study doctor can determine if the subject is tolerating the study medication and if she/he is seeing any benefit. These visits will last approximately 45 minutes. The Investigator will review AEs, ADHD-RS-IV, and CGI-I scores, and use clinical judgment to ensure that subjects are titrated to an acceptable dose of VyvanseTM for evaluation.
The following procedures will be conducted at each dose optimization visit:
- Sitting Vital Signs (oral or tympanic temperature, pulse, blood pressure and respiratory rate)
- Subject Weight (using a calibrated scale)
- Investigator Dose Assessment
- ADHD-RS-IV
- Clinical Global Impressions Improvement Scale (CGI-I).
- Study Drug Accountability and Compliance Assessment Performed
- Distribute Open-Label Study Drug
- Concomitant Medications
- Adverse Events Dose Optimized NIRS and GORT Testing
This visit will be similar to the baseline visit. Subjects will arrive early in the morning and medication will be administered on-site. They will remain on site for the next 4 hours so that the dose will be at peak effect before administering the GORT or NIRS. The following procedures will happen during this visit:
- Sitting Vital Signs after 5 minutes of rest (oral and tympanic temperature, pulse, blood pressure and respiratory rate)
- Subject weight (using a calibrated scale)
- An electrocardiogram will be performed.
- Serum Pregnancy Test for all FOCP - A negative serum pregnancy test must be documented for the end of the study.
- ADHD-RS-IV
- CGI-I
- Study Drug Accountability and Compliance Assessment Performed
- Concomitant Medications
- Adverse Events
- Medication administered on-site
- Near Infrared Spectroscopy and Attention Task performed once.
- Administer the Gray's Oral Reading Test.
- Physical examination including height (using a calibrated stadiometer)
- 12 Lead ECG 30-day Follow-up Phone Call
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vyvanse Treatment | Experimental | Drug: VyvanseAll subjects were tested at baseline before medication and then titrated to best dose and retested on Vyvanse Medication. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Females of child-bearing potential must have a negative pregnancy test.
- Subjects must meet DSM-IV-TR™ criteria for a primary diagnosis of ADHD.
- Subjects must have an ADHDRS-IV-Parent: Inv total score at least 1.5 standard deviations above the age and gender norms.
- The subject is functioning at an age appropriate level intellectually as determined by an IQ score of ≥ 80 on the Kaufman Brief Intelligence Test.
- The subject and subject's parent or legal guardian must be willing and able to comply with all the testing and dosing requirements in this study.
Key exclusion criteria (14 listed)
- Subject has any documented, current, controlled psychiatric illness [except Oppositional Defiant Disorder (ODD)]. The child may continue participating in a behavior modification program during this study as long as he/she has been participating in the program for at least one month at the time of the baseline visit.
- Subject has Conduct Disorder (CD).
- Subject has a documented allergy, hypersensitivity or intolerance to amphetamines, which is the class of drug to which Vyvanse™ belongs.
- Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
- Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine).
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 |
|---|---|---|
| VyvanseAlso: lisdexamfetamine dimesylateSubjects will participate in an open-label dose optimization period and successful titration to an optimal dose of Vyvanse™, subjects will take their optimized dose of Vyvanse™ (30, 50 or 70 mg/day) during the week leading up to their final visit. During the study subjects will take their prescribed dose once a day in the morning with breakfast. | Drug | Vyvanse Treatment |
Primary outcome
Gray Oral Reading Rest, Fourth Edition (GORT-4)
Time frame: baseline and final day (lab school Assessments)
The GORT-4 evaluates oral reading rate, accuracy and comprehension. Both Forms A and B were used.Half of the subjects randomly were tested on From A at baseline and the other half were tested with Form B. The GORT-4 is a standardized measure/test. Scores provided are standard scores, which range from 1 to 20, with a Mean of 10 and Standard Deviation of 3. A higher score means better reading performance. There was no total score used or calculated in this study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20978273Wigal SB, Maltas S, Crinella F, Stehli A, Steinhoff K, Lakes K, Schuck S. Reading performance as a function of treatment with lisdexamfetamine dimesylate in elementary school children diagnosed with ADHD. J Atten Disord. 2012 Jan;16(1):23-33. doi: 10.1177/1087054710378008. Epub 2010 Oct 26.
- Individual participant dataSharing planned: No
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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.
Kimberley Lakes, PhD principal investigator
UC Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vyvanse in people with Attention Deficit/Hyperactivity Disorder, run by Kimberley Lakes at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 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 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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 14 Feb 2018). 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?
Gray Oral Reading Rest, Fourth Edition (GORT-4) (time frame: baseline and final day (lab school Assessments)). 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 NCT00733356, 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 14 Feb 2018.