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CompletedNCT00563706Updated Mar 20, 2014Results posted

Study Evaluating Vabicaserin in Subjects With Schizophrenia

A Phase 2 interventional study of vabicaserin and risperidone in Schizophrenia, sponsored by Pfizer. Completed at 33 sites in 2 countries. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-03-20.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
199
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Male
01

Study summary

The primary purpose of this protocol is to establish the efficacy, safety, and tolerability of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of schizophrenia.

02

Conditions studied

  • Schizophrenia

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03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 199 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Generally healthy, men and women, aged 18 to 65.
  • Hospitalization because of an acute exacerbation of schizophrenia with a diagnosis of schizophrenia established greater than 1 year.
  • Ability to remain hospitalized for the duration of the screening period and for 4 weeks of double-blind treatment.

Exclusion criteria

Exclusion Criteria:

  • Current Axis I primary psychiatric diagnosis other than schizophrenia (DSM-IV-TR criteria).
  • Current diagnosis or history of substance abuse or dependence (DSM-IV-TR criteria), including alcohol (except for nicotine), within 3 months before baseline (day -1).
  • Subjects taking high or chronic doses of benzodiazepine at the screening evaluation who, in the investigator's judgment, would be likely to have severe withdrawal symptoms upon discontinuation.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
199 participants (actual)

Study arms

  • Experimental
    1

    Drug: vabicaserin

  • Active comparator
    2

    4mg/day

    Drug: risperidone

  • Placebo comparator
    3

    matching placebo

    Other: placebo

Interventions

  • Drugvabicaserin

    This study will utilize a randomized, double-blind, placebo-controlled, comparator-referenced, multicenter, parallel-group adaptive design with placebo, risperidone (4 mg/day), and up to 7 treatment arms of vabicaserin (50, 100, 150, 200, 300, 400 and 600 mg/day) over the course of the study

  • Drugrisperidone
  • Otherplacebo
06

What researchers measure

Primary outcomes

  1. Positive and Negative Symptom Scale (PANSS) Total Score at Baseline

    PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.

    Time frame: Baseline

  2. Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28

    PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.

    Time frame: Baseline, Day 28

Secondary outcomes

  1. Positive and Negative Symptom Scale (PANSS) Positive Subscale Score

    PANSS positive subscale assesses positive symptoms associated with schizophrenia. The positive subscale consists of 7 items (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49; higher score indicates greater severity.

    Time frame: Baseline, Day 7, 14, 21, 28

  2. Positive and Negative Symptom Scale (PANSS) Negative Subscale Score

    PANSS negative subscale assesses negative symptoms associated with schizophrenia. The negative subscale consists of 7 items (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49; higher score indicates greater severity.

    Time frame: Baseline, Day 7, 14, 21, 28

  3. Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score

    General psychopathology subscale assesses general psychopathology symptoms associated with schizophrenia. The general psychopathology subscale consists of 16 items (somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total general psychopathology subscale scores range from 16 to 112; higher score indicates greater severity.

    Time frame: Baseline, Day 7, 14, 21, 28

  4. Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score

    Cognition cluster subscale assesses cognitive symptoms associated with schizophrenia. The cognition cluster subscale score is a sum of 5 items from positive, negative and general psychopathology subscales (conceptual disorganization, difficulty in abstract thinking, poor attention, lack of judgment and insight, and preoccupation). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total cognition cluster subscale scores range from 5 to 35; higher score indicates greater severity.

    Time frame: Baseline, Day 7, 14, 21, 28

  5. Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score

    Responders were defined as 20 percent (%) responders and 50 % responders. A 20% responder was a participant whose PANSS total score was decreased by at least 20% from baseline to the week of assessment. A 50% responder was a participant whose PANSS total score was decreased by at least 50 % from baseline to the week of assessment. PANSS total score assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.

    Time frame: Baseline, Day 7, 14, 21, 28

  6. Clinical Global Impression - Severity (CGI-S) Score

    CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).

    Time frame: Baseline, Day 7, 14, 21, 28

  7. Clinical Global Impression - Improvement (CGI-I) Score

    CGI-I: 7-point clinician rated scale to assess global improvement in the participant's clinical state compared to baseline; range: 1 (very much improved) to 7 (very much worse).

    Time frame: Day 7, 14, 21, 28

  8. Calgary Depression Scale for Schizophrenia (CDSS) Score

    CDSS: 9-item clinician rated scale, validated for rating the severity of depressive symptoms in participants with schizophrenia. Each item is rated on a 4-point scale ranging from 0 (absent) to 3 (severe). CDSS total score is the sum of each item scores and ranges from 0 to 27; higher score indicates more severity of symptoms.

    Time frame: Baseline, Day 7, 14, 21, 28

07

Results

Posted Mar 20, 2014
Limitations and caveats
Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.

Participant flow

DB Treatment Period (Day 1 up to Day 28)
Participant flow — DB Treatment Period (Day 1 up to Day 28)
MilestonePlaceboVabicaserin 50 mgVabicaserin 100 mgVabicaserin 150 mgVabicaserin 200 mgVabicaserin 300 mgVabicaserin 400 mgVabicaserin 600 mgRisperidone
Started37188191619123043
Completed201339111491632
Not completed1755105531411
Withdrew: Adverse event411100015
Withdrew: Lack of efficacy212412251
Withdrew: Withdrawal by subject932543163
Withdrew: Discontinuation of study by sponsor200000010
Withdrew: Other000000012
Taper Phase (Day 29 up to Day 35)
Participant flow — Taper Phase (Day 29 up to Day 35)
MilestonePlaceboVabicaserin 50 mgVabicaserin 100 mgVabicaserin 150 mgVabicaserin 200 mgVabicaserin 300 mgVabicaserin 400 mgVabicaserin 600 mgRisperidone
Started201339111491632
Completed201339111491632
Not completed000000000

Outcome measures

PrimaryPositive and Negative Symptom Scale (PANSS) Total Score at Baseline

PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.

Time frame:
Baseline
Reported as:
Mean · units on a scale
Positive and Negative Symptom Scale (PANSS) Total Score at Baseline
units on a scalePlaceboVabicaserin 50 mgVabicaserin 100 mgVabicaserin 150 mgVabicaserin 200 mgVabicaserin 300 mgVabicaserin 400 mgVabicaserin 600 mgRisperidone
Positive and Negative Symptom Scale (PANSS) Total Score at Baseline94.74 ± 11.1894.24 ± 8.4296.88 ± 14.54101.33 ± 12.9793.06 ± 8.8494.39 ± 8.7392.83 ± 10.2595.54 ± 12.4691.43 ± 10.83
PrimaryChange From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28

PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.

Time frame:
Baseline, Day 28
Reported as:
Least squares mean · units on a scale
Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28
units on a scalePlaceboVabicaserin 50 mgVabicaserin 100 mgVabicaserin 150 mgVabicaserin 200 mgVabicaserin 300 mgVabicaserin 400 mgVabicaserin 600 mgRisperidone
Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28-17.03 ± 3.59-4.72 ± 4.87-10.26 ± 8.35-5.41 ± 5.18-13.42 ± 5.17-6.13 ± 4.80-13.84 ± 5.93-7.30 ± 4.09-15.59 ± 3.20
Statistical analysis
  • Placebo vs Vabicaserin 50 mg · Mixed Models Analysis · p = 0.043 · Least squares (ls) mean difference: -12.30 · 95% CI -24.24 to -0.37
  • Placebo vs Vabicaserin 100 mg · Mixed Models Analysis · p = 0.457 · Ls mean difference: -6.77 · 95% CI -24.70 to 11.16
  • Placebo vs Vabicaserin 150 mg · Mixed Models Analysis · p = 0.067 · Ls mean difference: -11.61 · 95% CI -24.03 to 0.81
  • Placebo vs Vabicaserin 200 mg · Mixed Models Analysis · p = 0.567 · Ls mean difference: -3.61 · 95% CI -16.02 to 8.80
  • Placebo vs Vabicaserin 300 mg · Mixed Models Analysis · p = 0.070 · Ls mean difference: -10.90 · 95% CI -22.71 to 0.92
  • Placebo vs Vabicaserin 400 mg · Mixed Models Analysis · p = 0.647 · Ls mean difference: -3.18 · 95% CI -16.87 to 10.50
  • Placebo vs Vabicaserin 600 mg · Mixed Models Analysis · p = 0.075 · Ls mean difference: -9.73 · 95% CI -20.46 to 1.00
  • Placebo vs Risperidone · Mixed Models Analysis · p = 0.765 · Ls mean difference: -1.44 · 95% CI -10.92 to 8.04
SecondaryPositive and Negative Symptom Scale (PANSS) Positive Subscale Score

PANSS positive subscale assesses positive symptoms associated with schizophrenia. The positive subscale consists of 7 items (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49; higher score indicates greater severity.

Time frame:
Baseline, Day 7, 14, 21, 28

No measurements were reported for this outcome.

SecondaryPositive and Negative Symptom Scale (PANSS) Negative Subscale Score

PANSS negative subscale assesses negative symptoms associated with schizophrenia. The negative subscale consists of 7 items (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49; higher score indicates greater severity.

Time frame:
Baseline, Day 7, 14, 21, 28

No measurements were reported for this outcome.

SecondaryPositive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score

General psychopathology subscale assesses general psychopathology symptoms associated with schizophrenia. The general psychopathology subscale consists of 16 items (somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total general psychopathology subscale scores range from 16 to 112; higher score indicates greater severity.

Time frame:
Baseline, Day 7, 14, 21, 28

No measurements were reported for this outcome.

SecondaryPositive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score

Cognition cluster subscale assesses cognitive symptoms associated with schizophrenia. The cognition cluster subscale score is a sum of 5 items from positive, negative and general psychopathology subscales (conceptual disorganization, difficulty in abstract thinking, poor attention, lack of judgment and insight, and preoccupation). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total cognition cluster subscale scores range from 5 to 35; higher score indicates greater severity.

Time frame:
Baseline, Day 7, 14, 21, 28

No measurements were reported for this outcome.

SecondaryPercentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score

Responders were defined as 20 percent (%) responders and 50 % responders. A 20% responder was a participant whose PANSS total score was decreased by at least 20% from baseline to the week of assessment. A 50% responder was a participant whose PANSS total score was decreased by at least 50 % from baseline to the week of assessment. PANSS total score assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.

Time frame:
Baseline, Day 7, 14, 21, 28

No measurements were reported for this outcome.

SecondaryClinical Global Impression - Severity (CGI-S) Score

CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).

Time frame:
Baseline, Day 7, 14, 21, 28

No measurements were reported for this outcome.

SecondaryClinical Global Impression - Improvement (CGI-I) Score

CGI-I: 7-point clinician rated scale to assess global improvement in the participant's clinical state compared to baseline; range: 1 (very much improved) to 7 (very much worse).

Time frame:
Day 7, 14, 21, 28

No measurements were reported for this outcome.

SecondaryCalgary Depression Scale for Schizophrenia (CDSS) Score

CDSS: 9-item clinician rated scale, validated for rating the severity of depressive symptoms in participants with schizophrenia. Each item is rated on a 4-point scale ranging from 0 (absent) to 3 (severe). CDSS total score is the sum of each item scores and ranges from 0 to 27; higher score indicates more severity of symptoms.

Time frame:
Baseline, Day 7, 14, 21, 28

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—4/37 (10.8%)28/37 (75.7%)
Vabicaserin 50 mg—0/18 (0%)12/18 (66.7%)
Vabicaserin 100 mg—1/8 (12.5%)6/8 (75%)
Vabicaserin 150 mg—0/19 (0%)11/19 (57.9%)
Vabicaserin 200 mg—0/16 (0%)13/16 (81.3%)
Vabicaserin 300 mg—1/19 (5.3%)13/19 (68.4%)
Vabicaserin 400 mg—2/12 (16.7%)10/12 (83.3%)
Vabicaserin 600 mg—2/30 (6.7%)23/30 (76.7%)
Risperidone—3/43 (7%)35/43 (81.4%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventPlaceboVabicaserin 50 mgVabicaserin 100 mgVabicaserin 150 mgVabicaserin 200 mgVabicaserin 300 mgVabicaserin 400 mgVabicaserin 600 mgRisperidone
Psychotic disorderPsychiatric disorders0/370/181/80/190/160/191/121/300/43
HypotensionVascular disorders0/370/180/80/190/160/191/120/300/43
Homicidal ideationPsychiatric disorders2/370/180/80/190/160/190/120/300/43
Suicidal ideationPsychiatric disorders2/370/180/80/190/160/190/121/301/43
SchizophreniaPsychiatric disorders0/370/180/80/190/161/190/120/301/43
AgitationPsychiatric disorders1/370/180/80/190/160/190/120/300/43
DepressionPsychiatric disorders1/370/180/80/190/160/190/120/300/43
Schizophrenia, undifferentiated typePsychiatric disorders1/370/180/80/190/160/190/120/300/43
Respiratory tract infectionInfections and infestations0/370/180/80/190/160/190/120/301/43
Intentional self-injuryPsychiatric disorders0/370/180/80/190/160/190/120/301/43
Most frequent other events
Showing 10 of 103
Most frequent other events
EventPlaceboVabicaserin 50 mgVabicaserin 100 mgVabicaserin 150 mgVabicaserin 200 mgVabicaserin 300 mgVabicaserin 400 mgVabicaserin 600 mgRisperidone
NauseaGastrointestinal disorders3/371/181/82/191/161/192/123/304/43
VomitingGastrointestinal disorders2/372/181/80/190/161/192/123/300/43
Weight increasedInvestigations1/371/180/81/190/161/192/120/306/43
DizzinessNervous system disorders2/371/181/80/192/160/191/125/303/43
Extrapyramidal disorderNervous system disorders3/371/181/83/192/160/190/122/303/43
DiarrhoeaGastrointestinal disorders5/372/180/81/192/161/190/122/303/43
HeadacheNervous system disorders5/371/181/81/191/161/191/123/304/43
ConstipationGastrointestinal disorders0/371/180/81/191/162/190/124/303/43
ConjunctivitisEye disorders0/370/180/80/192/160/190/120/300/43
DyspepsiaGastrointestinal disorders2/371/181/80/190/160/190/122/302/43

Baseline characteristics

Safety population included all randomized participants who received at least 1 dose of double-blind test article.

Age, Continuous
Age, Continuous(years)PlaceboVabicaserin 50 mgVabicaserin 100 mgVabicaserin 150 mgVabicaserin 200 mgVabicaserin 300 mgVabicaserin 400 mgVabicaserin 600 mgRisperidoneTotal
Mean42.05 ± 9.8843.22 ± 10.1741.25 ± 4.8940.53 ± 11.4342.94 ± 8.2740.74 ± 10.2938.17 ± 9.7343.60 ± 9.2542.72 ± 9.9342.07 ± 9.67
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboVabicaserin 50 mgVabicaserin 100 mgVabicaserin 150 mgVabicaserin 200 mgVabicaserin 300 mgVabicaserin 400 mgVabicaserin 600 mgRisperidoneTotal
Female841453061041
Male29147151116122433161
08

Study locations

33 sites
  • Pfizer Investigational Site
    Little Rock, Arkansas 72201, United States
  • Pfizer Investigational Site
    Cerritos, California 90703, United States
  • Pfizer Investigational Site
    Escondido, California 92025, United States
  • Pfizer Investigational Site
    Garden Grove, California 92845, United States
  • Pfizer Investigational Site
    Glendale, California 91206, United States
  • Pfizer Investigational Site
    San Diego, California 92103, United States
  • Pfizer Investigational Site
    San Diego, California 92123, United States
  • Pfizer Investigational Site
    Torrance, California 90502, United States
  • Pfizer Investigational Site
    Washington, District of Columbia 20016, United States
  • Pfizer Investigational Site
    Aventura, Florida 33180, United States
  • Pfizer Investigational Site
    Hollywood, Florida 33021, United States
  • Pfizer Investigational Site
    Kissimmee, Florida 34741, United States
  • Pfizer Investigational Site
    Hoffman Estates, Illinois 60169, United States
  • Pfizer Investigational Site
    Indianapolis, Indiana 46222, United States
  • Pfizer Investigational Site
    Lake Charles, Louisiana 70601, United States
  • Pfizer Investigational Site
    Baltimore, Maryland 21202, United States
  • Pfizer Investigational Site
    Rockville, Maryland 20850, United States
  • Pfizer Investigational Site
    Hamilton, New Jersey 08619, United States
  • Pfizer Investigational Site
    Willingboro, New Jersey 08046, United States
  • Pfizer Investigational Site
    Cedarhurst, New York 11516, United States
  • Pfizer Investigational Site
    Holliswood, New York 11423, United States
  • Pfizer Investigational Site
    New York, New York 10032, United States
  • Pfizer Investigational Site
    Butner, North Carolina 27509, United States
  • Pfizer Investigational Site
    Oklahoma City, Oklahoma 73103, United States
  • Pfizer Investigational Site
    Philadelphia, Pennsylvania 19131, United States
  • Pfizer Investigational Site
    Austin, Texas 78754, United States
  • Pfizer Investigational Site
    Austin, Texas 78756, United States
  • Pfizer Investigational Site
    Bellaire, Texas 77008, United States
  • Pfizer Investigational Site
    DeSoto, Texas 75115, United States
  • Pfizer Investigational Site
    Houston, Texas 77008, United States
  • Pfizer Investigational Site
    Arlington, Virginia 22201, United States
  • Pfizer Investigational Site
    Portsmouth, Virginia 23707, United States
  • Pfizer Investigational Site
    Kingston, Ontario K7L 4X3, Canada
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00563706
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Nov 26, 2007
Start date
Dec 2007
Primary completion
Jun 2008
Completion
Jun 2008
Results posted
Mar 20, 2014
Last update
Mar 20, 2014

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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