Patients will be randomized to self treat with 2 g of VM1001 cream times daily for ten days, have a five day wash out period and then 10 days of self treatment with the comparator.

Patients will be randomized to self treat with either active product or placebo comparator thrice daily for 10 days followed by a 5 day wash out period then 10 days of experimental treatment thrice daily for 20 days.

Treatment of PHN

3VM1001

Cream without investigational drug. Self treatment 3 times daily for 10 days

Placebo

Medex Healthcare Research, Inc.

Medex Healthcare Reasearch, Inc.

3VM1001 Cream for the Treatment of Pain Associated With Post Herpetic Neuralgia (PHN)

A Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Tolerability of 3VM1001 Cream for the Treatment of Pain Associated With Post-Herpetic Neuralgia: A Proof of Concept Study

The time averaged mean of all patient pain scores over each study period; trend over time for each treatment sill be assessed by day of therapy to evaluate any increase or decrease in effect for each study treatment.

Collection of adverse events and the number of subjects discontinuing he study

This measure is a single-item rating by participants of their improvement with treatment on a 7-point sale that ranges from "very much improved" to very much worse" with "no change "the mid-midpoint".

Patient Global Assessment of Treatment Satisfaction from baseline to the end of each study phase. Patients will rate their overall satisfaction with study treatment using a 5-point categorical scale.

recording of the use of rescue mediation at each phase of the study.

CDA Research Group, Inc.

Double-blind, Placebo-controlled, Crossover study to evaluate treatment and tolerability of the experimental product for treatment of post herpetic pain.

Subjects will be randomized to receive either treatment wih 3VM1001 cream or the comparator daily for 10 days followed by 5 day wash out period before 10 days of treatment with the comparator or investigational treatment, .

Days 1 - 7, IV uptitration; days 8 - 14, final daily dose administered orally"

Days 1 through 7: i.v. matching placebo Days 8 through 14: p.o. matching placebo QD

Hemorrhagic Stroke

Intracerebral Hemorrhage (ICH)

Supplied as an i.v. solution for days 1 through 7 and as a tablet for days 8 through 14

BAF312

Supplied as an i.v. solution for days 1 through 7 and as tablets for days 8 through 14

Novartis Investigative Site

Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral Hemorrhage (ICH).

A Phase II, Patient- and Investigator-blinded, Randomized, Placebo-controlled Study to Evaluate Efficacy, Safety and Tolerability of BAF312 (Siponimod) in Patients With Stroke Due to Intracerebral Hemorrhage (ICH)

aPHE volume measured by CT scans on Day 14 after ICH.

Blood samples will be collected to assess plasma concentrations.

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

Novartis Pharmaceuticals

This is a randomized, patient- and investigator-blinded, placebo-controlled, parallel group study of BAF312 on top of standard-of-care for ICH, consisting of 3 epochs: Screening/Baseline, Treatment (Day 1-14), and Follow-Up (to Day 90)

Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.

Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.
Tocilizumab: Therapeutic/Pharmacologic Class of Drug:
Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.
Type of Dosage Form:
Concentrate for solution for infusion.
Route of Administration:
Intravenous (i.v.) infusion.

Tocilizumab

Sex: Female, Male

The Brief Assessment of Cognition in Schizophrenia (BACS) is the metric used to characterize cognition in this study. The BACS consists of 6 subscales: Verbal Memory (range 0-75), Working Memory (range 0-28), Motor Speed (range 0-100), Verbal Fluency (measure is total number of words generated in two 60 second trials), Attention and Processing speed (range 0-110), and Executive Function (range 0-22). For each subscale, higher scores reflect better cognition. For each subscale, a Standard Deviation Score was calculated based on normative data (Keefe et al. Norms and standardization of the Brief Assessment of Cognition in Schizophrenia (BACS). Schizophrenia Research 102 (2008) 108-115). The BACS composite score is calculated as the average Standard Deviation Score of the 6 subscale scores. The change in BACS composite score was calculated as the BACS composite score at 8 weeks minus the BACS composite score at baseline.

Change in Cognition

The Positive and Negative Symptoms Scale (PANSS) is the metric used to characterize psychotic symptoms in this study. The PANSS consists of 30 items, each scored 1-7. The range for the PANSS total score is 30-210. There are 3 subscales - PANSS positive score (range 7-49), PANSS negative score (range 7-49), and PANSS general score (range 16-112). PANSS total score is the summation of these 3 subscales. Higher values for the total and subscale scores reflect more severe psychopathology. A positive change in PANSS total score reflects an increase in psychopathology. A negative change in PANSS total score reflects a decrease in psychopathology.

Change in Total Psychotic Symptoms

Following a screening evaluation, participants will receive two infusions of Tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of Tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.
Tocilizumab: Therapeutic/Pharmacological Class of Drug:
Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.
Type of Dosage Form:
Concentrate for solution for infusion.
Route of Administration:
Intravenous (i.v.) infusion.

Overall Study

Dr. Brian Miller

Schizophrenia

Therapeutic/Pharmacologic Class of Drug:
Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.
Type of Dosage Form:
Concentrate for solution for infusion.
Route of Administration:
Intravenous (i.v.) infusion.

Georgia Health Sciences University

An Open-Label Trial of Tocilizumab in Schizophrenia

Brian Miller

Assistant Professor

2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)

Fingolimod

Disease Modifying Therapy (MS_DMT)

Total

Comparison effectiveness of fingolimod versus approved first-line disease modifying therapies by measuring the rate of participant retention on randomized treatment over a 12-month period (Full analysis set)

Disease Modifying Therapy (MS-DMT)

Participant Retention Rate Over 12 Months

Reasons for discontinuation in participants treated with fingolimod vs. DMT over 12 months of treatment
Total discontinued (Primary reason): Fingolimod arm: 27, MS-DMT arm: 27 = 54 participants
Total discontinued (Secondary reason): Fingolimod arm: 257, MS-DMT arm: 256 = 513 participants
Throughout the study, investigators evaluated each patient for occurrence of randomized treatment discontinuation and determined the primary and secondary reasons for such discontinuation. At every visit, the investigator evaluated the patients and determined if they should continue on randomized treatment or change to alternative treatment. Treatment discontinuation was a clinically meaningful measure related to safety, efficacy, and tolerability over time, reflecting the therapeutic effectiveness of study treatment.

Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set

Summary statistics Compare cognitive impairment measured by Symbol Digit Modalities Test (SDMT) scores. The SDMT score and its change from baseline value were summarized by visit. For the change from baseline values at each visit, ANCOVA adjusted for treatment naivety, corresponding baseline values, and age was performed for treatment comparisons
The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.
NOTE: Higher scores indicate better performance.

Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Oral Test) by Visit (Randomized Treatment / Randomized Phase)

Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Written Test) by Visit (Randomized Treatment / Randomized Phase)

Summary statistics for percent change from month 12 in brain volume by visit (Randomized treatment / randomized phase) in patients treated with fingolimod vs.DMTs as measured by MRI

Disease Modifying Therapy

Percent Change From Baseline in Brain Volume From Month 12 to Last Visit (Randomized)

Summary statistics for Medication Satisfaction Questionnaire[Question: "Overall, how satisfied are you with your current medication?"] (Randomized treatment / randomized phase): Fingolimod vs MS-DMT

Disease Modifying Therapy (DS-DMT)

Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score

Study Director

MS DMT

Relapsing Remitting Multiple Sclerosis

Disease Modifying therapy

Results for CFTY720DUS09 from the Novartis Trial Results database

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis.

A 12-month, Prospective, Randomized, Active-controlled, Open-label Study to Evaluate the Patient Retention of Fingolimod vs. Approved First-line Disease Modifying Therapies in Adults With Relapsing Remitting Multiple Sclerosis (PREFERMS)

chickenpox/ödem

3VM1001 Cream for the Treatment of Pain Associated With Post Herpetic Neuralgia (PHN)

Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral Hemorrhage (ICH).

An Open-Label Trial of Tocilizumab in Schizophrenia

Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis.

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