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The purpose of the study was to determine in patients currently being administered antipsychotic pharmacotherapy whether PEAR-004 could further reduce symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS).
The overall rationale for the study was to assess the first prescription digital therapeutic (PDT) in schizophrenia using a form of proven psychosocial intervention, cognitive behavioral therapy (CBT), to supplement standard of care with antipsychotic medications.
This was a randomized, sham-controlled, rater-blinded, parallel group trial. Overall, 112 subjects were randomized 1:1 in to the following groups:
Subjects in both groups continued to receive their clinician-directed standard-of-care treatment for schizophrenia, including pharmacotherapy. Subjects in Group A used PEAR 004 and subjects in Group B used a sham for a period of 12 weeks. Subjects returned to the clinic for outpatient visits at Week 4 (day 29), Week 8 (day 57), and Week 12 (day 85). At each visit, standard assessments were performed according to the assessment schedule, including PANSS, ISST-Plus, CGI, BMQ, MAP-SR, WHOQOL-BREF, BDI-II, ISI, and adverse events (AEs). A final follow-up visit was performed at Week 16 (day 115),
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEAR-004 | Experimental | Eligible participants were able to access PEAR-004 (an investigational digital therapeutic) on a mobile device (iOS and Android based) as needed to receive suggestions about coping strategies to overcome difficulties in daily life. |
|
| Sham | Sham Comparator | Eligible participants were able to access a sham control downloaded on a mobile device (iOS and Android based) as needed to receive notifications prompting the participant to open the sham app, which displayed a prescription timer for the remaining duration of app availability. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEAR-004 | Device | PEAR-004 (an investigational digital therapeutic) or sham (control) was downloaded to the subject's phone and then the assigned application was unlocked using a prescription code provided by Pear Therapeutics. As this was a digital therapeutic device study, dose or mode of administration is not applicable. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score | The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms. | Baseline, Day 29, Day 57, Day 85 |
| Percent of Dropout | Dropout rate to evaluate retention to assigned study treatment | Day 115 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Positive PANSS Score | The PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale (eg, delusions, conceptual disorganization, hallucinatory behavior); 7 items that make up the Negative Scale (eg, blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology Scale (eg, somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Individual items are scored with values ranging from 1 to 7. Total Negative and Positive Subscale scores each range from 7 to 49; higher score indicates greater severity. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Garden Grove | California | 92845 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35343910 | Derived | Ghaemi SN, Sverdlov O, van Dam J, Campellone T, Gerwien R. A Smartphone-Based Intervention as an Adjunct to Standard-of-Care Treatment for Schizophrenia: Randomized Controlled Trial. JMIR Form Res. 2022 Mar 28;6(3):e29154. doi: 10.2196/29154. |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicatrials.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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The eligible subjects were randomized in 1:1 ratio to receive either PEAR-004 or sham.
This study was conducted at 6 centers in the USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | PEAR-004 | Eligible participants were to access PEAR-004 (an investigational digital therapeutic) on a mobile device (iOS and Android based) as needed to receive suggestions about coping strategies to overcome difficulties in daily life. |
| FG001 | Sham | Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set = all randomized participants who received the study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | PEAR-004 | Eligible participants were to access PEAR-004 (an investigational digital therapeutic) on a mobile device (iOS and Android based) as needed to receive suggestions about coping strategies to overcome difficulties in daily life. |
| BG001 | Sham |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score | The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms. | Full Analysis Set (FAS) | Posted | Least Squares Mean | Standard Error | Score | Baseline, Day 29, Day 57, Day 85 |
|
Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 119 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PEAR-004 | Eligible participants were to access PEAR-004 (an investigational digital therapeutic) on a mobile device (iOS and Android based) as needed to receive suggestions about coping strategies to overcome difficulties in daily life. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 15, 2019 | Sep 11, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 12, 2018 | Sep 11, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001523 | Mental Disorders |
| D011618 | Psychotic Disorders |
| D006212 | Hallucinations |
| D010259 | Paranoid Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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|
| Sham | Device | PEAR-004 (an investigational digital therapeutic) or sham (control) was downloaded to the subject's phone and then the assigned application was unlocked using a prescription code provided by Pear Therapeutics. As this was a digital therapeutic device study, dose or mode of administration is not applicable. |
|
| Baseline, Day 29, Day 57, Day 85 |
| Change From Baseline in the General Psychopathology PANSS Score | The PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale (eg, delusions, conceptual disorganization, hallucinatory behavior); 7 items that make up the Negative Scale (eg, blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology Scale (eg, somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Individual items are scored with values ranging from 1 to 7. Total General Psychopathology Subscale score range from 16 to 112; higher score indicates greater severity. | Baseline, Day 29, Day 57, Day 85 |
| Change From Baseline in the Negative PANSS Score | The PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale (eg, delusions, conceptual disorganization, hallucinatory behavior); 7 items that make up the Negative Scale (eg, blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology Scale (eg, somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Individual items are scored with values ranging from 1 to 7. Total Negative and Positive Subscale scores each range from 7 to 49; higher score indicates greater severity. | Baseline, Day 29, Day 57, Day 85 |
| Change From Baseline in the Motivation and Pleasure Self-report (MAP-SR) Score | The MAP-SR is a 15-item self-report measure that provides a total score index of current motivation/pleasure negative symptoms. Responses are given on a 5-point scale where 0 = no pleasure or motivation and 4 = extreme pleasure or motivation. Total scores range from 0 to 60 and higher scores indicate greater motivation and pleasure during everyday activities. | Baseline, Day 29, Day 57, Day 85 |
| Change From Baseline in the World Health Organization Quality of Life (WHOQOL-BREF) Scale | The WHOQOL-BREF is a 26-item, self-report questionnaire and short version of WHOQOL-100, consisting of 4 domains: physical health (7 items) (Domain 1), psychological health (6 items) (Domian 2), social relationships (3 items) (Domain 3), and environmental health (8 items) (Domain 4); it also contains QOL and general health items. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Each individual item of the WHOQOL-BREF is scored from 1=not at all to 5=completely on a response scale, which is stipulated as a 5-point ordinal scale. The scores are then transformed linearly to a scale of 0 (the worse quality of life) to 100 (the worse quality of life). | Baseline, Day 29, Day 57, Day 85 |
| Change From Baseline in the Beck Depression Inventory, Second Ed. (BDI-II) Total Score | Beck Depression Inventory (BDI) is a 21-items self reported inventory with a scale evaluating depressive symptoms and the changes in BDI after treatment compared to baseline. The range of scores is 0 to 63, with higher scores indicating greater severity of depression. | Baseline, Day 29, Day 57, Day 85 |
| Percentage Change From Baseline in Total PANSS Score (Within Assigned Treatment Group) | The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms. | Baseline, Day 29, Day 57, Day 85 |
| Percentage of Responders as Assessed by the Brief Medication Questionnaire (BMQ) | The Brief Medication Questionnaire (BMQ) collects information about current schizophrenia medication use. | Day 29, Day 57, and Day 85 |
| Percentage of Responders as Assessed by the Total PANSS Score | A Response is defined as a reduction of at least 20% at day 85 or last visit in total PANSS score relative to Baseline. | Day 85 |
| Number of Patients With Adverse Events | Adverse events, serious adverse events, and adverse events leading to discontinuation throughout the study | Day 115 |
| Number of Patients With Vital Sign Measurements | Vital signs at baseline, day 85 or last visit | Day 85 |
| InterSePT Scale for Suicidal Thinking-Plus (ISST-Plus) Score | InterSePT Scale for Suicidal Thinking-Plus (ISST-Plus) score. Semi-structured interview to assess severity of suicidal ideation and behavior Part I: collects information on 7 days prior to visit; 13 items scored 0 (min) to 2 (max) for suicidality, with a higher score representing a worse outcome Part II: collects information on suicidal behavior since last visit, with nominal categories Yes / No / Unknown (NA) Part III: global rating of status at time of interview; scored 0 (min) to 5 (max) for suicidality, with a higher score representing a worse outcome. Please note that only part III score (severity of suicidal risk) was summarized and reported. | Baseline, Day 29, 57, 85, and 115 |
| Oakland |
| California |
| 94607 |
| United States |
| Novartis Investigative Site | Torrance | California | 90502 | United States |
| Novartis Investigative Site | Maitland | Florida | 32751 | United States |
| Novartis Investigative Site | Grand Rapids | Michigan | 49548 | United States |
| Novartis Investigative Site | Albuquerque | New Mexico | 87102 | United States |
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Disease duration at baseline | Disease Duration at baseline: Duration (in Years) from informed consent to date of diagnosis. Date of diagnosis corresponds to date where subjects reported schizophrenia diagnosis in medical history at screening visit. | Mean | Standard Deviation | Years |
|
| Total Positive and Negative Syndrome Scale (PANSS) score at baseline | The Positive and Negative Syndrome Scale (PANSS) assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms. | Mean | Standard Deviation | Score |
|
| OG001 | Sham | Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability. |
|
|
|
| Primary | Percent of Dropout | Dropout rate to evaluate retention to assigned study treatment | Randomized Set | Posted | Count of Participants | Participants | Day 115 |
|
|
|
| Secondary | Change From Baseline in the Positive PANSS Score | The PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale (eg, delusions, conceptual disorganization, hallucinatory behavior); 7 items that make up the Negative Scale (eg, blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology Scale (eg, somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Individual items are scored with values ranging from 1 to 7. Total Negative and Positive Subscale scores each range from 7 to 49; higher score indicates greater severity. | Full Analysis Set (FAS) | Posted | Least Squares Mean | Standard Error | Score | Baseline, Day 29, Day 57, Day 85 |
|
|
|
|
| Secondary | Change From Baseline in the General Psychopathology PANSS Score | The PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale (eg, delusions, conceptual disorganization, hallucinatory behavior); 7 items that make up the Negative Scale (eg, blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology Scale (eg, somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Individual items are scored with values ranging from 1 to 7. Total General Psychopathology Subscale score range from 16 to 112; higher score indicates greater severity. | Full Analysis Set (FAS) | Posted | Least Squares Mean | Standard Error | Score | Baseline, Day 29, Day 57, Day 85 |
|
|
|
|
| Secondary | Change From Baseline in the Negative PANSS Score | The PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale (eg, delusions, conceptual disorganization, hallucinatory behavior); 7 items that make up the Negative Scale (eg, blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology Scale (eg, somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Individual items are scored with values ranging from 1 to 7. Total Negative and Positive Subscale scores each range from 7 to 49; higher score indicates greater severity. | Full Analysis Set (FAS) | Posted | Least Squares Mean | Standard Error | Score | Baseline, Day 29, Day 57, Day 85 |
|
|
|
|
| Secondary | Change From Baseline in the Motivation and Pleasure Self-report (MAP-SR) Score | The MAP-SR is a 15-item self-report measure that provides a total score index of current motivation/pleasure negative symptoms. Responses are given on a 5-point scale where 0 = no pleasure or motivation and 4 = extreme pleasure or motivation. Total scores range from 0 to 60 and higher scores indicate greater motivation and pleasure during everyday activities. | Full Analysis Set (FAS) | Posted | Least Squares Mean | Standard Error | Score | Baseline, Day 29, Day 57, Day 85 |
|
|
|
|
| Secondary | Change From Baseline in the World Health Organization Quality of Life (WHOQOL-BREF) Scale | The WHOQOL-BREF is a 26-item, self-report questionnaire and short version of WHOQOL-100, consisting of 4 domains: physical health (7 items) (Domain 1), psychological health (6 items) (Domian 2), social relationships (3 items) (Domain 3), and environmental health (8 items) (Domain 4); it also contains QOL and general health items. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Each individual item of the WHOQOL-BREF is scored from 1=not at all to 5=completely on a response scale, which is stipulated as a 5-point ordinal scale. The scores are then transformed linearly to a scale of 0 (the worse quality of life) to 100 (the worse quality of life). | Full Analysis Set (FAS) | Posted | Least Squares Mean | Standard Error | Score | Baseline, Day 29, Day 57, Day 85 |
|
|
|
|
| Secondary | Change From Baseline in the Beck Depression Inventory, Second Ed. (BDI-II) Total Score | Beck Depression Inventory (BDI) is a 21-items self reported inventory with a scale evaluating depressive symptoms and the changes in BDI after treatment compared to baseline. The range of scores is 0 to 63, with higher scores indicating greater severity of depression. | Full Analysis Set (FAS) | Posted | Least Squares Mean | Standard Error | Score | Baseline, Day 29, Day 57, Day 85 |
|
|
|
| Secondary | Percentage Change From Baseline in Total PANSS Score (Within Assigned Treatment Group) | The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms. | Full Analysis Set (FAS) | Posted | Least Squares Mean | Standard Error | Score | Baseline, Day 29, Day 57, Day 85 |
|
|
|
| Secondary | Percentage of Responders as Assessed by the Brief Medication Questionnaire (BMQ) | The Brief Medication Questionnaire (BMQ) collects information about current schizophrenia medication use. | Full Analysis Set (FAS) | Posted | Count of Participants | Participants | Day 29, Day 57, and Day 85 |
|
|
|
| Secondary | Percentage of Responders as Assessed by the Total PANSS Score | A Response is defined as a reduction of at least 20% at day 85 or last visit in total PANSS score relative to Baseline. | Full Analysis Set (FAS) | Posted | Count of Participants | Participants | Day 85 |
|
|
|
| Secondary | Number of Patients With Adverse Events | Adverse events, serious adverse events, and adverse events leading to discontinuation throughout the study | Safety Set (SAF) | Posted | Count of Participants | Participants | Day 115 |
|
|
|
| Secondary | Number of Patients With Vital Sign Measurements | Vital signs at baseline, day 85 or last visit | Posted | Number | Number of participants | Day 85 |
|
|
|
| Secondary | InterSePT Scale for Suicidal Thinking-Plus (ISST-Plus) Score | InterSePT Scale for Suicidal Thinking-Plus (ISST-Plus) score. Semi-structured interview to assess severity of suicidal ideation and behavior Part I: collects information on 7 days prior to visit; 13 items scored 0 (min) to 2 (max) for suicidality, with a higher score representing a worse outcome Part II: collects information on suicidal behavior since last visit, with nominal categories Yes / No / Unknown (NA) Part III: global rating of status at time of interview; scored 0 (min) to 5 (max) for suicidality, with a higher score representing a worse outcome. Please note that only part III score (severity of suicidal risk) was summarized and reported. | The number of subjects analyzed at different visits may differ from the overall number analyzed within a treatment group because some patients missed some visits. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Day 29, 57, 85, and 115 |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Sham | Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability. | 0 | 55 | 1 | 55 | 0 | 55 |
| EG002 | Total | Total | 0 | 110 | 1 | 110 | 0 | 110 |
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Day 57 |
|
|
| Day 85 |
|
|
Day 57 |
| Comparison of adjusted least square mean |
| 0.61 |
| Standard Error of the Mean |
| 0.538 |
| 2-Sided |
| 90 |
| -0.3 |
| 1.5 |
mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects. |
| Other |
| Day 85 | t-test, 2 sided | 0.2069 | Comparison of adjusted least square mean | 0.82 | Standard Error of the Mean | 0.648 | 2-Sided | 90 | -0.3 | 1.9 | mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects. | Other |
| Day 57 |
|
|
| Day 85 |
|
|
Day 57 |
| Comparison of adjusted least square mean |
| 0.12 |
| Standard Error of the Mean |
| 0.890 |
| 2-Sided |
| 90 |
| -1.4 |
| 1.6 |
mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects. |
| Other |
| Day 85 | t-test, 2 sided | 0.1368 | Comparison of adjusted least square mean | 1.61 | Standard Error of the Mean | 1.071 | 2-Sided | 90 | -0.2 | 3.4 | Other |
| Day 57 |
|
|
| Day 85 |
|
|
Day 57 |
| Comparison of adjusted least square mean |
| 0.15 |
| Standard Error of the Mean |
| 0.453 |
| 2-Sided |
| 90 |
| -0.6 |
| 0.9 |
mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects. |
| Other |
| t-test, 2 sided | 0.3798 | Comparison of adjusted least square mean | 0.51 | Standard Error of the Mean | 0.581 | 2-Sided | 90 | -0.5 | 1.5 | mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects. | Other |
| Day 57 |
|
|
| Day 851.43 |
|
|
Day 57 |
| Comparison of adjusted least square mean |
| -1.60 |
| Standard Error of the Mean |
| 2.006 |
| 2-Sided |
| 90 |
| -4.9 |
| 1.7 |
mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects. |
| Other |
| Day 85 | t-test, 2 sided | 0.0245 | Comparison of adjusted least square mean | -4.07 | Standard Error of the Mean | 1.780 | 2-Sided | 90 | -7.0 | -1.1 | mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects. | Other |
| Day 57-Domain 1 |
|
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| Day 85-Domain 1 |
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| Day 29-Domain 2 |
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| Day 57-Domain 2 |
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| Day 85-Domain 2 |
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| Day 29-Domain 3 |
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| Day 57-Domain 3 |
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| Day 85-Domain 3 |
|
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| Day 29-Domain 4 |
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| Day 57-Domain 4 |
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| Day 85-Domain 4 |
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| Day 57 |
|
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| Day 85 |
|
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| Day 57 |
|
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| Day 85 |
|
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| Day 57 |
|
| Day 85 |
|
| Day 115 / End of Study |
|
| Participants with at least one SAE |
|
| AEs leading to discontinuation of study treatment |
|
| Study-drug related AEs leading to treatment disc. |
|
| Day 1 |
|
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| Day 29 |
|
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| Day 57 |
|
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| Day 85 |
|
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| Day 115 / End Of Study |
|
|