HyponatremiaPhase 3INSIGHTNCT00550459
Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic Patients
A Phase 3 study testing Tolvaptan in people with Hyponatremia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 12 sites in United States.
Trial summary
Demonstrate an improvement in the composite scores of validated neurocognitive tests in elderly subjects with chronic sub-clinical (i.e., asymptomatic) hyponatremia. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hyponatremia
- What is being tested?
- Tolvaptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 12 sitesUnited States
- Study dates
- Aug 2007to Mar 2009
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and men 50 years of age or older.
- Serum Sodium ≥123 and ≤ 134 mEq/L [mmol/L]at screening and baseline.
- Subjects with serum sodium concentrations ≥118 and ≤122 mEq/L[mmol/L] at screening and baseline may be entered into the trial based on consultation and approval from the study medical monitor.
Who cannot join
- Conditions or history which may present a safety concern to the subject or their offspring or extreme susceptibility to hypotension with sudden fluid loss (aquaresis).
- Hyponatremia that is acute, easily reversible, artifactual, or due to a condition not associated with vasopressin excess or likely to respond to aquaretic therapy.
- Conditions associated with an independent imminent risk of morbidity and mortality.
- Conditions which may confound the assessment of endpoints, history of poor compliance, participation in a clinical trial believed by the PI or Sponsor likely to confound endpoint assessments.
- Conditions which may confound primary endpoints of cognitive function.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Mitchell Rosner, MD
Charlottesville, Virginia, 22908
Pikes Peak Cardiology
Colorado Springs, Colorado, 80907
Carolina Research Associates
Columbia, South Carolina, 29201
Rockdale Medical Research Associates
Conyers, Georgia, 30094
Lillestol Research, LLC
Fargo, North Dakota, 58106
Sarah. S. Olelewe, MD
Hawthorne, California, 90250
Memorial Clinical Associates
Houston, Texas, 77043
Innovative Research of West FL
Largo, Florida, 33770
Wayne O. Wells, MD
Lebanon, Tennessee, 37087
Otis Barnum, DO
Natchitoches, Louisiana, 71457
Coastal Nephrology Assoc. Research Center
Punta Gorda, Florida, 33950
Progressive Clinical Research
Vista, California, 92083
About this study
Official title: A Pilot, Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Effects of Titrated Oral Tolvaptan 15, 30, or 60 mg QD on Cognitive and Neurological Function in Elderly Hyponatremic Patients
Demonstrate an improvement in the composite scores of validated neurocognitive tests in elderly subjects with chronic sub-clinical (i.e., asymptomatic) hyponatremia.
Read the detailed description
Subjects will be randomized, with stratification by baseline sodium <130 or ≥ 130 mEq/L[mmol/L] to receive either tolvaptan 15 mg tablet or matching placebo tablet at doses of 15, 30 or 60 mg for 21 days. During this period, fluid restrictions should be loosened or suspended, until the subject's response to therapy can be evaluated, typically over the first few days of therapy. Fluid restriction may be reinstituted at any time in subjects whose sodium fails to improve or worsens with study therapy. A forced-titration up to 60 mg of study drug by day 3 to 7 will be based on the subject's serum sodium Subjects entering the study with a serum sodium concentration less than 130 mEq/L[mmol/L] may be fluid restricted if necessary at the discretion of the Investigator. Subjects should be monitored closely during the first 24 hours of treatment for dosing titration. The total dosing duration will be up to 21 days (plus 3 day treatment window). Subjects will return to the clinic on Day 22 (+3 days) for assessments and will complete a follow-up visit on Day 28 (+2 days).
- Conditions
- Hyponatremia
- Being tested
- Tolvaptan, Placebo
- Keywords
- Hyponatremia, Cognitive, Neurological Function, Elderly
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolvaptanDrug
Also called OPC-41061
15-60 mg oral tablet given once a day for 21 days.
PlaceboDrug
Placebo tablet given once daily for 21 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo tablet given once a day for 21 days Receives: Drug: Placebo |
| 2 | Active comparator | Tolvaptan 15 mg-60 mg tablet given once a day for 21 days. Receives: Drug: Tolvaptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Neurocognitive Composite Score of Speed Domains (NCS-SD; Sum of All Correct Speed Domain Z-Scores)
Change from baseline to Day 22 in sum of all speed domain Z-scores:Reaction Time (Simple=recognize "yes" 50 times;Choice=recognize "yes" or "no" 50 times;Digit Vigilance=match 45 digits);Psychomotor Speed (Morse Tapping=tap button for 30 seconds with right \& left hands);Processing Speed (Rapid Visual Information Processing=detect consecutive sequences of 3 odd or 3 even digits;Numeric Working Memory=recognize numbers from series of 5 digits among 30;Word Recognition=remember 15 prior learned words from 30 total;results age-matched to healthy controls from Cognitive Drug Research normative data
Measured: baseline and Day 22
Secondary outcomes (28)
Change From Baseline to Day 22 in the Individual Neurocognitive Domains Included in the Primary Endpoint: Reaction Time in Computer Tests
Change from baseline in the individual neurocognitive domains Z-score for Reaction Time in Computer Tests (simple reaction time test, choice reaction time test, digit vigilance test); ITT population
Measured: baseline and Day 22
Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Psychomotor Speed Via Morse Tapping Test
Change from baseline to Day 22 in the individual neurocognitive domains Z-score for Psychomotor Speed (mean tap rate of Morse tapping test); ITT population
Measured: baseline and Day 22
Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Processing Speed of Rapid Visual Information Processing Test, Numeric Working Memory Test, and Word Recognition Test
Change from baseline to Day 22 in the individual neurocognitive domains Z-score for Processing Speed of Rapid Visual Information Processing Test, Numeric Working Memory Test, and Word Recognition Test; ITT population
Measured: baseline and Day 22
Change From Baseline in Overall Neurocognitive Composite Score
Change from Baseline to Day 22 in the overall Neurocognitive Composite Score (NCS)comprising the sum of 7 neurocognitive domain Z-scores (Reaction Time, Psychomotor Speed, Processing Speed, Continuity of Attention, Working Memory/Executive Functions, Quality of Episodic Verbal Memory, and Postural Stability); ITT population
Measured: baseline and Day 22
Change From Baseline in Gait Test (Timed Get-Up-and-Go Test)
Change from baseline to Day 22 in Gait Test (Timed Get-Up-and-Go Test=time it takes for a seated subject to rise from a chair, walk 3 meters, walk around an object and return to sit in chair. Values: under 10 sec (no difficulties), 10 to 20 sec (starting to have balance difficulty), over 30 sec (at high risk for falls and dependent in most activities of daily living and mobility); test assesses risk to elderly subjects of falling and higher scores in seconds indicate higher risk of falling; ITT population
Measured: baseline and Day 22
Change From Baseline in Postural Stability Test
Change from baseline to Day 22 in Postural Stability Test Z-score (This test measures gross motor control. The ability to stand upright without moving is assessed using the SWAY meter that is modeled on the Wright Ataxiameter. A cord from the meter is attached to the subject who is required to stand as still as possible with feet apart and eyes closed for 1 minute. The test is then repeated with eyes open for 1 minute. The outcomes of these tests are combined and measured as a movement Z-score. Higher result=better postural stability); ITT population
Measured: baseline and Day 22
Change From Baseline in Serum Sodium; ITT Population
Change from Baseline to Day 22 in Serum Sodium; ITT population
Measured: Baseline and Day 22
Number of Patients With Vital Sign Abnormalities: Blood Pressure
Incidence of abnormal systolic \& diastolic blood pressure values post-baseline (abnormal systolic values: >=180 mmHg + increase of >=20 mmHg, <= 90 mmHg + decrease >=20 mmHg; abnormal diastolic values: >=105 mmHg+increase of >=15 mmHg, <=50 mmHg + decrease of >= 15 mmHg)
Measured: 28 days
Number of Patients With Vital Sign Abnormalities: Pulse Rate
Incidence of abnormal pulse rate post-baseline [abnormal values: >=120 beats per minute (bpm) + increase of >=15 bpm; <=50 bpm + decrease of >=15 bpm]
Measured: 28 days
Number of Patients With Vital Sign Abnormalities: Body Weight
Incidence of clinically significant body weight change post-baseline (defined as change upward or downward of >=7%)
Measured: 28 days
Number of Patients With Vital Sign Abnormalities: Body Temperature
Incidence of potentially clinically significant changes in body temperature post-baseline (defined as an increase of >=1.1 to >=38.3 degrees Celsius)
Measured: 28 days
Number of Patients With Hematology Laboratory Abnormalities: Hemoglobin
Incidence of clinically significant hemoglobin abnormalities post-baseline (normal range=11.8-16.8 g/dL)
Measured: 28 days
Number of Patients With Hematology Laboratory Abnormalities: Activated Partial Thromboplastin Time (aPTT)
Incidence of potentially clinically significant Activated Partial Thromboplastin Time (aPTT) levels post-baseline (normal range=22-34 seconds)
Measured: 28 days
Number of Patients With Hematology Laboratory Abnormalities: Lymphocytes
Incidence of potentially clinically significant lymphocyte count post-baseline (normal range = 16-46%)
Measured: 28 days
Number of Patients With Hematology Laboratory Abnormalities: Neutrophils
Incidence of potentially clinically significant neutrophil count post-baseline (normal range=1.8-8 thousands/microliter)
Measured: 28 days
Number of Patients With Serum Chemistry Laboratory Abnormalities: Blood Urea Nitrogen (BUN)
Incidence of potentially clinically significant BUN levels post-baseline (normal range=7-30 mg/dL)
Measured: 28 days
Number of Patients With Serum Chemistry Laboratory Abnormalities: Uric Acid
Incidence of potentially clinically significant uric acid levels post-baseline (normal range=4-8.5 mg/dL)
Measured: 28 days
Number of Patients With Serum Chemistry Laboratory Abnormalities: Cholesterol
Incidence of potentially clinically significant cholesterol levels post-baseline (normal range=0-199 mg/dL)
Measured: 28 days
Number of Patients With Serum Chemistry Laboratory Abnormalities: Glucose
Incidence of potentially clinically significant glucose levels post-baseline (normal range=70-125 mg/dL)
Measured: 28 days
Number of Patients With Serum Chemistry Laboratory Abnormalities: Magnesium
Incidence of potentially clinically significant magnesium levels post-baseline (normal range=1.2-2 mEq/L)
Measured: 28 days
Number of Patients With Electrocardiogram (ECG) Abnormalities: QT >500 Milliseconds (Msec)
Incidence of potentially clinically significant ECG abnormalities (QT>500 msec) post-baseline
Measured: 28 days
Number of Patients With Electrocardiogram (ECG) Abnormalities: QRS Interval
Incidence of potentially clinically significant ECG abnormalities involving QRS interval (change > 100 msec)
Measured: 28 days
Number of Patients With Electrocardiogram (ECG) Abnormalities: QTcB Increase 30-60 Msec
Incidence of potentially clinically significant ECG abnormalities (QTcB increase 30-60 msec)
Measured: 28 days
Number of Patients With Electrocardiogram (ECG) Abnormalities: QTcF Increase 30-60 Msec
Incidence of potentially clinically significant ECG abnormalities (QTcF increase 30-60 msec post-baseline)
Measured: 28 days
Number of Patients With Electrocardiogram (ECG) Abnormalities: ST Segment
Incidence of potentially clinically significant ECG abnormalities: ST Segment
Measured: 28 days
Number of Patients With Electrocardiogram (ECG) Abnormalities: T Wave
Incidence of potentially clinically significant ECG abnormalities: T wave
Measured: 28 days
Number of Patients With Electrocardiogram (ECG) Abnormalities: Right Bundle Branch Block (RBBB), Left Bundle Branch Block (LBBB), Myocardial Infarction (MI)
Incidence of potentially clinically significant ECG abnormalities: Right bundle branch block (RBBB), Left bundle branch block (LBBB), myocardial infarction (MI)
Measured: 28 days
Number of Patients With Electrocardiogram (ECG) Abnormalities: Arrhythmia
Incidence of potentially clinically significant ECG abnormalities: arrhythmia
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2007 (estimated)
- Study startAug 2007
- Primary completionFeb 2009
- Study completionMar 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.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Investigators
- Joseph Verbalis, MD, Principal investigator, Georgetown University, Washington, DC, 20007 USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550459
- Sponsor's protocol ID
- 156-04-246
- Other IDs
- INSIGHT
- Acronym
- INSIGHT
- Status last verified
- Apr 2011
- First submitted
- 25 Oct 2007
- Last updated
- 28 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Effects of Titrated Oral Tolvaptan 15, 30, or 60 mg QD on Cognitive and Neurological Function in Elderly Hyponatremic Patients
- ClinicalTrials.gov ID
- NCT00550459
- Acronym / sponsor ID
- INSIGHT / 156-04-246
- Conditions
- Hyponatremia
- Keywords
- Hyponatremia, Cognitive, Neurological Function, Elderly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- Aug 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 29 Oct 2007 (estimated)
- Results
- Posted 28 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Demonstrate an improvement in the composite scores of validated neurocognitive tests in elderly subjects with chronic sub-clinical (i.e., asymptomatic) hyponatremia.
Detailed description
Subjects will be randomized, with stratification by baseline sodium <130 or ≥ 130 mEq/L[mmol/L] to receive either tolvaptan 15 mg tablet or matching placebo tablet at doses of 15, 30 or 60 mg for 21 days. During this period, fluid restrictions should be loosened or suspended, until the subject's response to therapy can be evaluated, typically over the first few days of therapy. Fluid restriction may be reinstituted at any time in subjects whose sodium fails to improve or worsens with study therapy. A forced-titration up to 60 mg of study drug by day 3 to 7 will be based on the subject's serum sodium Subjects entering the study with a serum sodium concentration less than 130 mEq/L[mmol/L] may be fluid restricted if necessary at the discretion of the Investigator. Subjects should be monitored closely during the first 24 hours of treatment for dosing titration. The total dosing duration will be up to 21 days (plus 3 day treatment window). Subjects will return to the clinic on Day 22 (+3 days) for assessments and will complete a follow-up visit on Day 28 (+2 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo tablet given once a day for 21 days |
| 2 | Active comparator | Drug: TolvaptanTolvaptan 15 mg-60 mg tablet given once a day for 21 days. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women and men 50 years of age or older.
- Serum Sodium ≥123 and ≤ 134 mEq/L [mmol/L]at screening and baseline.
- Subjects with serum sodium concentrations ≥118 and ≤122 mEq/L[mmol/L] at screening and baseline may be entered into the trial based on consultation and approval from the study medical monitor.
Key exclusion criteria (5 listed)
- Conditions or history which may present a safety concern to the subject or their offspring or extreme susceptibility to hypotension with sudden fluid loss (aquaresis).
- Hyponatremia that is acute, easily reversible, artifactual, or due to a condition not associated with vasopressin excess or likely to respond to aquaretic therapy.
- Conditions associated with an independent imminent risk of morbidity and mortality.
- Conditions which may confound the assessment of endpoints, history of poor compliance, participation in a clinical trial believed by the PI or Sponsor likely to confound endpoint assessments.
- Conditions which may confound primary endpoints of cognitive function.
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 |
|---|---|---|
| TolvaptanAlso: OPC-4106115-60 mg oral tablet given once a day for 21 days. | Drug | 2 |
| PlaceboPlacebo tablet given once daily for 21 days | Drug | 1 |
Primary outcome
Change From Baseline in the Neurocognitive Composite Score of Speed Domains (NCS-SD; Sum of All Correct Speed Domain Z-Scores)
Time frame: baseline and Day 22
Change from baseline to Day 22 in sum of all speed domain Z-scores:Reaction Time (Simple=recognize "yes" 50 times;Choice=recognize "yes" or "no" 50 times;Digit Vigilance=match 45 digits);Psychomotor Speed (Morse Tapping=tap button for 30 seconds with right \& left hands);Processing Speed (Rapid Visual Information Processing=detect consecutive sequences of 3 odd or 3 even digits;Numeric Working Memory=recognize numbers from series of 5 digits among 30;Word Recognition=remember 15 prior learned words from 30 total;results age-matched to healthy controls from Cognitive Drug Research normative data
28 secondary outcomes
Change From Baseline to Day 22 in the Individual Neurocognitive Domains Included in the Primary Endpoint: Reaction Time in Computer Tests
Time frame: baseline and Day 22
Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Psychomotor Speed Via Morse Tapping Test
Time frame: baseline and Day 22
Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Processing Speed of Rapid Visual Information Processing Test, Numeric Working Memory Test, and Word Recognition Test
Time frame: baseline and Day 22
Change From Baseline in Overall Neurocognitive Composite Score
Time frame: baseline and Day 22
Change From Baseline in Gait Test (Timed Get-Up-and-Go Test)
Time frame: baseline and Day 22
Change From Baseline in Postural Stability Test
Time frame: baseline and Day 22
Change From Baseline in Serum Sodium; ITT Population
Time frame: Baseline and Day 22
Number of Patients With Vital Sign Abnormalities: Blood Pressure
Time frame: 28 days
Number of Patients With Vital Sign Abnormalities: Pulse Rate
Time frame: 28 days
Number of Patients With Vital Sign Abnormalities: Body Weight
Time frame: 28 days
Number of Patients With Vital Sign Abnormalities: Body Temperature
Time frame: 28 days
Number of Patients With Hematology Laboratory Abnormalities: Hemoglobin
Time frame: 28 days
Number of Patients With Hematology Laboratory Abnormalities: Activated Partial Thromboplastin Time (aPTT)
Time frame: 28 days
Number of Patients With Hematology Laboratory Abnormalities: Lymphocytes
Time frame: 28 days
Number of Patients With Hematology Laboratory Abnormalities: Neutrophils
Time frame: 28 days
Number of Patients With Serum Chemistry Laboratory Abnormalities: Blood Urea Nitrogen (BUN)
Time frame: 28 days
Number of Patients With Serum Chemistry Laboratory Abnormalities: Uric Acid
Time frame: 28 days
Number of Patients With Serum Chemistry Laboratory Abnormalities: Cholesterol
Time frame: 28 days
Number of Patients With Serum Chemistry Laboratory Abnormalities: Glucose
Time frame: 28 days
Number of Patients With Serum Chemistry Laboratory Abnormalities: Magnesium
Time frame: 28 days
Number of Patients With Electrocardiogram (ECG) Abnormalities: QT >500 Milliseconds (Msec)
Time frame: 28 days
Number of Patients With Electrocardiogram (ECG) Abnormalities: QRS Interval
Time frame: 28 days
Number of Patients With Electrocardiogram (ECG) Abnormalities: QTcB Increase 30-60 Msec
Time frame: 28 days
Number of Patients With Electrocardiogram (ECG) Abnormalities: QTcF Increase 30-60 Msec
Time frame: 28 days
Number of Patients With Electrocardiogram (ECG) Abnormalities: ST Segment
Time frame: 28 days
Number of Patients With Electrocardiogram (ECG) Abnormalities: T Wave
Time frame: 28 days
Number of Patients With Electrocardiogram (ECG) Abnormalities: Right Bundle Branch Block (RBBB), Left Bundle Branch Block (LBBB), Myocardial Infarction (MI)
Time frame: 28 days
Number of Patients With Electrocardiogram (ECG) Abnormalities: Arrhythmia
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Verbalis, MD principal investigator
Georgetown University, Washington, DC, 20007 USA
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tolvaptan in people with Hyponatremia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 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 28 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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 28 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Neurocognitive Composite Score of Speed Domains (NCS-SD; Sum of All Correct Speed Domain Z-Scores) (time frame: baseline and Day 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2011.