Clinical Trial Centers Alliance

Clinical Trial Centers Alliance

Presented October 2013Bobbie TheodoreAlliance Director

[email protected]

Independent (Non-SMO) entities in California, Texas and Florida comprise the AllianceCombined 500+ clinical trials conducted, phases I-IVCentral IRBLarge patient databases, affiliated medical practices and proven recruitment methods

www.clinicaltrialcenters.com

Alliance Facilities - CALIFORNIA

Pacific Research Partners, LLCSan Francisco area, CA

Inpatient and outpatient psychiatry (10 beds with flexible capacity)

Collaborative Neuroscience Network, LLC Long Beach, CA

25,000 sq ft dedicated research facilityClinical Pharmacology Unit – 60+ bed phase I unit for healthy subjects, and CNS, general medical, bioequivalence and ethno-bridging patient populationsPsychiatric Health Facility – separate 20 bed, private rooms, licensed psychiatric health care unit for inpatient psychiatric populationsInpatient and outpatient neurology and general medical patient populations

Garden Grove, and Torrance, CAOutpatient psychiatry


Alliance Facilities - TEXAS

FutureSearch Trials, LP

Austin, TXInpatient and outpatient psychiatry (30 beds) including phase I special populationsInpatient and outpatient sleep disorders (6 bed sleep lab for PSG studies)Outpatient general medical, neurology and pain disorders

Dallas, TXInpatient and outpatient psychiatry (10 beds with flex capacity)Outpatient Alzheimer's disease, cognitive dysfunction, pain, and insomnia disorders

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Alliance Facilities - FLORIDA

Outpatient Alzheimer’s, cognitive dysfunction, MCI, general medicine, and pain disorders

Florida Clinical Research Center, LLC

Bradenton, FLInpatient and outpatient psychiatry, pediatric - adult (10 beds with flexible capacity)Outpatient general medicine and pain disorders

Maitland, FLInpatient and outpatient psychiatry, pediatric – adult (30 beds with flex capacity)

David Walling, PhD Armen Goenjian, MD Donald Garcia, MD

Omid Omidvar, MD Mark Leibowitz, MD Michael Downing, MD

Ira Glick, MD Steven Reynolds, DO Nirav Patel, MD John D. Hudson, MD

CALIFORNIA TEXAS FLORIDA

Andrew Cutler, MD Richard Knapp, DO

Joanne Northcutt, PhD Jose Zaglul, MD


Curriculum Vitae

Click on names to view CVs:

David P. Walling, Ph.D. CEO and PI – CNS Network, LLC Armen K. Goenjian, M.D., D.F.A.P.A., F.A.C.G.S. PI and Partner – CNS Network, LLC Omid Omidvar, M.D. PI – CNS Network, LLC Nirav S. Patel, M.D. PI – CNS Network, LLC Steven Reynolds, D.O. PI – CNS Network, LLCMark Leibowitz, M.D. – PI – CNS Network, LLC Ira D. Glick, M.D. PI – Pacific Research Partners, LLCDonald J. Garcia, M.D. President and PI – FutureSearch Clinical Trials, LPJohn Douglas Hudson, M.D. PI– FutureSearch Trials of Neurology, LPMichael Downing, M.D. PI– FutureSearch Trials of Dallas, LPAndrew J. Cutler, M.D. CEO and PI – Florida Clinical Research Center, LLCJose T. Zaglul, M.D. PI – Florida Clinical Research Center, LLCRichard D. Knapp, D.O. PI – Florida Clinical Research Center, LLCJoanne Northcutt, Ph.D. PI – Florida Clinical Research Center, LLC

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Site Highlights

Fulltime Dedicated and Highly Experienced Staff

Investigators Board Certified in Psychiatry, Neurology, Sleep Medicine, Internal Medicine, Family Practice, and Licensed Clinical PsychologistsProtocol consultants to sponsors and CROs in psychiatry, neurology and sleep indicationsFulltime certified psychometric and clinical raters – M.D., Ph.D. and M.A.-level with 3-10+ years rating experience

Multiple fulltime study coordinators including CCRCs, RNs, and LVNsDedicated recruitment specialists with established referral networks in their communitiesRegulatory, QA, training and IT personnel


Specialized Capabilities and Experience

Dedicated 25,000 sq ft Clinical Pharmacology Unit in Long Beach, CACardiac telemetry and holter monitoringQTc and TQTEEG and qEEG Evoked potentialsExtensive PK samplingImaging: 3T MRI Scanner capable of 3.0 Tesla fMRI procedures64-Slice PET/CT systemLumbar puncture and CSF collectionPSG (polysomnography) IV infusion, oral, device, and transdermal patch delivery systems


Phase I-IV Trial Experience

PsychiatryAddictions – smoking cessation, alcohol dependence, and binge eatingADHD – adult and child, including classroom ADHD studiesAnxiety – GAD, PTSDBipolar – bipolar depression, mania, mixedCognition – in schizophrenia, mild cognitive impairmentDepression – MDD, refractory/treatment resistant, depression with sexual dysfunctionSchizophrenia and schizoaffective disorders – acute, cognition, negative symptoms, stablePediatric psychiatry

NeurologyAlzheimer’s – MCI, mild-to-moderate, prodromal, and severePain – chronic pain, diabetic neuropathy, fibromyalgia, migraine, osteoarthritis, post herpetic neuralgiaParkinson’s – early stage to advancedPost-strokeMultiple Sclerosis – relapsing remittingSleep disorders – insomnia, narcolepsy, restless legs syndrome, shift worker, sleep apnea

General MedicalCOPD, asthma, hypercholesterolemia, hypertension, obesity, type 2 diabetes, women’s health


Recruitment and Retention

RecruitmentFull time dedicated recruitment and outreach specialists on staffLarge site databases accumulated over 13+ years of research across all indicationsAffiliated PI physician practice databasesEstablished relationships with network of physicians for additional patient referralsOutreach to and established relationships with residential facilities, board and cares, senior communitiesParticipation in community events and support groups – outreach specialists provide free seminars, lunch and learns, distribute flyers and postersHistory of successful print, web, radio, and television advertising – recruitment departments have established relationships with media buyers for discounted advertising rates and placementAbility to pre-qualify patients via IRB-approved pre-screen consent form

RetentionInpatient facilities have private rooms, double occupancy for caregivers or loved ones as neededSite-provided patient transportation as neededFulltime dedicated staff for regular contact with patient and familyReminder and follow-up phone callsMany of the study patients are treated in the PIs and Sub-Is practices allowing for ease in transition, follow up and retention


Affiliated Practices

Affiliated Medical PracticesCollaborative Neuroscience Network is aligned with largest psychiatry, neurology and family group practices in the LA and Orange County regions. Pacific Research Partners has exclusive relationship with largest mental health clinics in the San Francisco Bay Area.FutureSearch Trials in Austin is aligned with Neurologist/Sleep Medicine PI, Dr. Hudson’s large sleep medicine practice and sleep lab on premises of research facility. FutureSearch Trials in Dallas aligned with Dr. Downing‘s psychiatric practice. Both Austin and Dallas have community referral relationships with residential facilities and mental health agencies.Florida Clinical Research Center is aligned with Child Psychiatrist PI, Dr. Jose Zaglul. Child and Adult Psychiatrist Jose T. Zaglul, MD has joined Florida Clinical Research Center in a fulltime capacity while continuing to maintain his professional relationship with a large community mental health system in Bradenton, FL where he has been Chief Medical Officer for many years. He is now Medical Director for Florida Clinical Research Center and the primary PI for all inpatient studies and several outpatient studies.


Alliance Advantages and Expertise

Central IRBResponsiveness and ease of single point of contact with site relations team for rapid turnaround on site selection coordination and communications Dedicated regulatory and budget and contract staff for quick turnaround times Collaborative relationship with many CROs, including partnerships for monitoring and data management capabilities, if requestedShare best clinical and operational practices across sitesSite-based internal training programsPublications and advisory board membershipsClinical feedback and protocol consulting during development process, if neededAffiliation with full-service, boutique CRO for any combination of the following: protocol writing, data management, statistical analysis, vendor coordination, monitoring, general study management - can be utilized for stand-alone services or as sub-contractor to clinical trial site


Preferred Relationships with Sponsors and CROs

Protocol reviewPre-feasibility assessmentBudget estimates Master agreements in placeRapid start-up and first-patient-in

Rating Scale Experience:ACDSACRADAS-COGADCS-ADLADCS-CGIADFACSADRADMACQAIMSAISRS/ADHD RS-IVASEXBACSBAIBARSBASBDIBPI-SFBPRSBSSBVMTCAADID CAARS CAI

CANTABCADSSCBQCCTCDISCDR/CDR-SOBCDRS-RCDSSCFCGDSCGI-BP/I/S/SCA-SCIBICCIBIS-plusCOG STATECOWSCPRSCPTCRTTCSDDC-SSRSDADDCSQDESS

DSDSISDSM-IV DiagnosisDSSTEQ-5D 5L and 3L proxyESRSESSFAQFASTFCSRT-IRFIQFMSFOSQFTNDGAFGASGBIGDSGo/ No Go TaskHAM-AHAM-DHISHoehn & Yahr

HRUQHUIHVLTIADCQISIKBITK-SADSLSEQMADRSMATRICSMCCB (Matrics)MGH ATRQMINImMIDIMMSEMNSI Part bMoCAMOSMOS-SSMSLT NABNC070NDS

NDTNINCDSNPINPSNRSNSANTBNTSS-6NYPRSPAC-QoLPANSSPDQPGAPINRSPOMSPPSQAPQASP-R CSAPSPPSQIPUTSPWIPWC

QIDS-16QL21, QL 98Q-LES-QQOLQOL-ADRAVLTRSQ – D/WRUD-LiteRUSPRUQSANSSASSASSSBQ-RSCIDSCL-90SCOPASCoRSSDSSIBSIGH-DSLOFSOWS

SQLMSRTTSTSSWNTMTP 1, 2TrailsTSQMTSSRUPDRSVASWCSTWMSWOMACWPAIWRAADSWTARUPSAYBOCSYGTSSYMRS

Certified, experienced raters, including M.D., Ph.D. and M.A.-level


Phase I Special Populations Sample Metrics

Study Title# of Patients

Screened# of Patients Randomized

Length of Enrollment Year Status

A Phase I, prospective, randomized, double-blind, placebo-controlled, sequential-cohort, escalating, single-dose study designed to determine the maximum tolerated oral dose of XXX in healthy, male volunteers

54 27 2 months 2013 Active

A Phase Ib, Randomized, Double-Blind, Placebo-Controlled, Sponsor-Open, Study to Examine the Safety, Tolerability and Pharmacokinetics of XXX in Psychiatrically Stable Subjects with Schizophrenia

46 30 3 months 2012 Closed

A Phase I, Open-Label, Single Group, Multiple-Dose, Study to Evaluate the Pharmacokinetics of XXX Drug Delivery System following 24-hr Application in Patients Diagnosed with Parkinson’s Disease


A Phase I, 2-part, Open Label, Inpatient Study to Assess the Safety and Tolerability of Multiple Ascending Doses of XXX in Subjects with Schizophrenia (Extensive PKs & multiple ECGs)


Phase I, Inpatient Open-Label, Randomized, Parallel Group, Crossover Study to Compare the Pharmacokinetcs of XXX in Migraine Subjects During an Acute Migraine Attack and During a Non-Migraine Period

54 20 (SFs due to pts not having a

migraine in req’d window)

8 months 2012 TOP ENROLLING SITE

A Phase I, Inpatient Multicenter, Open-Label Study to Determine the Effects of XXX on Sleep in Healthy Subjects

26 13 5 months 2012 TOP ENROLLING SITE


Phase I Special Populations Sample Metrics (cont’d)




A Phase I, Parallel-Group, Double-Blind, Placebo and Positive Controlled Multiple Oral Dose Administration Trial to Evaluate the Effects of XXX on QT/QTc in Subjects with Schizophrenia or Schizoaffective Disorder

34 25 1 month 2012 Closed

A Phase I, Randomized, Double-Blind, Placebo-Controlled Study of Safety and Pharmacodynamic Effects of XXX in Major Depressive Disorder Subjects (Extensive PKs & multiple ECGs)

38 22 6 weeks (across 2

sites)

2011 TOP ENROLLING

SITE

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, Immunogenicity, Pharmacodynamic Response, and Pharmacokinetics of Intravenous Infusions of XXX in Subjects With Mild to Moderate Alzheimer’s Disease

Study design 5 cohorts; 1 pt/cohort from ea site

10 1-2 months depending on cohort

2011 TOP ENROLLING

SITE

A Phase I, Double-Blind, Randomized, Placebo-Controlled, Multiple, Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of XXX in Elderly Volunteers and in Subjects With Mild Alzheimer's Disease (included Lumbar Puncture and PET)

11 7 2 months 2011 RESCUE SITE

A Phase I, Effect of XXX on Ambulatory Heart Rate and Blood Pressure in Patients with Major Depressive Disorder who are being Treated with Selective Serotonin Reuptake Inhibitors

12 12 6 weeks 2011 Closed


Phase IIa Special Populations Sample Metrics




A Phase IIa Randomized, Double-Blind, Cross over Study Comparing the Tolerability of Two Dose Regimens of XXX in Adult Patients with Parkinson's Disease who are receiving XXX

11 10 1 month 2010 RESCUE SITE

A Phase I/IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety, and Efficacy of a Single Dose of XXX in Adults with Attention Deficit Hyperactivity Disorder (ADHD)


A Phase IIa, Multicenter, Double-Blind, Randomized, Parallel Group, 4-week Inpatient Treatment Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Two Fixed Doses of XXX Compared to Placebo, Using XXX as an Active Control, in the Treatment of Acute Exacerbation of Schizophrenia


A Phase IIa, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of XXX for Migraine Prophylaxis in Patients with Episodic Migraine


A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Oral Multiple Ascending Doses for XXX in Patients with Schizophrenia


A Phase IIa Placebo- and Positive-Controlled, Randomized Study, Evaluating QT and QTc Intervals following Administration of Immediate-Release of an Atypical Antipsychotic in Subjects with Schizophrenia or Schizoaffective Disorder

18 15 1 month(across 2

sites)

2007 Closed


ADHD Sample Metrics




A Phase III, Multicenter, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of XXX in Pediatric Patients with Attention Deficit Hyperactivity Disorder (ADHD) in a Laboratory Classroom


A Phase II, Double-blind, Randomized, Placebo-controlled, Multicenter, Fixed-dose, Study to Assess Efficacy, Safety and Tolerability of XXX in Adults with Inattentive-Predominant Attention Deficit/ Hyperactivity Disorder (ADHD)


A Phase II, 40-week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Efficacy and Safety Study of XXX in the Treatment of Adult Patients with Childhood-onset ADHD


A Phase III, Parallel, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Forced Dose Study to Evaluate the Safety and Efficacy of XXX Extended Release Capsules in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Pediatric and Adolescent Patients Aged 6 up to 18 years


A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multi-center, Fixed Dose Titration Study to Assess Efficacy, Safety, and Tolerability of XXX in Adults with Attention Deficit/Hyperactivity Disease (ADHD)

48 36 4 months(across 2

sites)

2010 Closed


ADHD Sample Metrics (cont’d)




A Phase III, Double-Blind, Randomized, Multicenter, Placebo Controlled, Dose Optimization Study Evaluating the Tolerability and Efficacy of AM and PM Once Daily Dosing with Extended-Release XXX in Children Aged 6-12 with Attention-Deficit/Hyperactivity Disorder


A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center, Dose Optimization Study Evaluating the Efficacy and Safety of XXX in Combination with Psychostimulants in Children and Adolescents Aged 6-17 with Attention-Deficit/Hyperactivity Disorder


sites)

2009 Closed

A Phase IV, Placebo-controlled, Double-blind, Parallel-group, Individualized Dosing Study Optimizing Treatment of Adults with Attention-Deficit/Hyperactivity Disorder to an Effective Response with XXX


A Phase IV, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3x3 Cross-Over Study Demonstrating Superior Efficacy of XXX Versus XXX in children, Aged 6-12 Years, with Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting



Alzheimer’s Sample Metrics




A Phase II Long-Term Efficacy Response Trial: The planned trial will be a six month, double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of daily administration of XXX in subjects with Mild to Moderate Alzheimer’s Disease

7 6 5 months 2013 Active

A Phase III, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Effectiveness of XXX for the Treatment of Mild to Moderate Alzheimer’s Disease (includes IGIV, and infusion)

15 10 14 months 2013 TOP ENROLLING

SITE

A Phase III, Randomized Controlled Trial to Assess the Efficacy of a Medical Food in Patients with Mild to Moderate Alzheimer’s Disease using Alzheimer’s Disease Medication


A Multicenter, Randomized Double-Blind Placebo-Controlled Study of the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of XXX in the Treatment of Patients with Mild to Moderate Alzheimer's Disease



Anxiety Sample Metrics




A Double-Blind, Placebo-Controlled, Flexible-Dose Study of XXX in Patients with Generalized Anxiety Disorder

18 10 6 months (across 2

sites)

2013 Active

A Phase II, Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study of 2 Oral Dose Groups of XXX, with a XXX Arm, in Subjects with Generalized Anxiety Disorder


A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of a Single Dose of XXX in Acute Treatment of Adults With Generalized Anxiety Disorder


A Phase III, Randomized Double-Blind, Parallel Group 10-week Placebo-Controlled Fixed Dose Study of XXX and XXX Evaluating the Efficacy and Safety of XXX for the Treatment of Generalized Anxiety Disorder


A Phase II, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Exploratory Study to Evaluate the Effect of XXX on Anxiety in Patients with Moderate to Severe Generalized Anxiety Disorder



Bipolar Sample Metrics




A Phase III, 24-Week, Flexible-Dose, Open-Label Extension Study of XXX for the Treatment of Bipolar I Depression


A Phase III, Long-Term Open-Label Study of the Safety and Tolerability of XXX in Patients with Bipolar I Disorder


SITE

A Multi-Center, Randomized, Parallel-Group, Double-Blind, Phase IV Comparison of the Efficacy and Safety of XXX (oral tablets daily in divided doses) to Placebo as Adjunct Therapy to Mood Stabilizers (XXX or XXX) in the Treatment of Bipolar I Disorder and Alcohol Dependence in Adult Patient Receiving Treatment for 12 Weeks


A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of XXX Monotherapy in the Treatment of Acutely Manic Patients with Bipolar I Disorder



Depression Sample Metrics




A Phase III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed Dose Study on the Efficacy of XXX on Cognitive Dysfunction in Adult Patients with Major Depressive Disorder


A Phase II, Multicenter, Randomized, Double-Blind, Active-Controlled Study of the Efficacy and Safety of Flexibly-Dosed XXX in Patients with Treatment Resistant Major Depression


A Phase III, Double-Blind, Randomized, Multi-Center, Placebo-Controlled, Relapse Prevention Study with XXX in Out-Patient Adults with Major Depressive Disorder


A Phase IV, Randomized, Double-Blind, Parallel Group Study to Compare Discontinuation Symptoms in Abrupt Discontinuation Versus a 1-Week Tapering Regimen in Subjects with Major Depressive Disorder Treated for 24 Weeks with Open-Label XXX


A Phase IV, Multi-center, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Functional Outcome in Outpatients with Major Depressive Disorder treated with XXX



Pain Sample Metrics




A Phase III, Randomized, Double-blind, Placebo-Controlled, Multicenter Trial with an Enriched Study Design to Assess the Efficacy and Safety of XXX Controlled-Release Tablets Compared to Placebo in Opioid-Experienced Subjects with Moderate to Severe Pain due to Chronic Low Back Pain who Require Around-the-clock Opioid Therapy


A Phase III, Open-Label, Multicenter Study to Assess the Long -Term Safety of XXX Once-Daily in Subjects with Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain


Phase IIb, Double Blind, Randomized, Placebo Controlled, Dose-Ranging Trial of XXX for the Acute Treatment of Migraine


A Phase III, Double-blind, Randomized, Placebo-controlled, Safety and Efficacy Study of Once Daily Controlled Release XXX in the Treatment of Patients with Fibromyalgia (13-week single and double blind phases, outpatient study including Actigraphy, PK, Multiple Psychiatric, Sleep & Pain Assessments, and Diary)


SITE

A Phase III, Multicenter, 12-Month, Open-Label, Single-Arm, Safety Study of XXX and XXX Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain


SITE


Pain Sample Metrics (cont’d)




A Phase IIb, 12-Week, Placebo-Controlled, Double-Blind, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of XXX in Subjects with Moderate to Severe Chronic Low Back Pain


A Phase III, Safety and Tolerability Study Comparing XXX Given as an Oral Solution to a Single-blinded Combination of Oral Tablets plus Oral Solution in Subjects with Fibromyalgia


A Six Month Phase II/III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of XXX for Prevention of Menstrually Related Migraine in Female Patients with Episodic Migraine


sites)

2010 Closed

A Phase IIa, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of XXX for Migraine Prophylaxis in Patients With Episodic Migraine


The Analgesic Efficacy And The Safety Of XXX And Placebo In Approximately 275 Subjects With Diabetic Neuropathic Pain


A Phase III Study of the Chronic Intermittent use of XXX and XXX in the Acute Treatment of Migraine Attacks With or Without Aura in Adults to Evaluate the Effect on Blood Pressure



Cognition in Schizophrenia and Schizophrenia Sample Metrics




A Phase II, 12 Week Randomized, Double-blind, Placebo-controlled, Parallel Group, Multiple Dose, Proof-of-Concept Study to Evaluate the Effects of XXX on Cognition in Stable Schizophrenia Patients

66 41 10 month(across 2

sites)

2013 Active

A Phase I, Open-label, Multiple Dose, Safety and Tolerability Study of XXX IM Depot Administered in the Deltoid Muscle in Adult Subjects with Schizophrenia


A 12-week, Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of XXX IM Depot in the Acute Treatment of Adults With Schizophrenia


A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study of 3 Doses of XXX versus Placebo in Patients with DSM-IV-TR Schizophrenia


A Phase II, Double Blind, Placebo Controlled, Multi-Center, Parallel Group Study to Assess Efficacy, Safety and Tolerability of XXX as Augmentation Therapy to Improve Cognition in Outpatients with Cognitive Dysfunction in Schizophrenia


A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Study of the Safety and Efficacy of XXX in the Treatment of Cognitive Deficits in Schizophrenia (CDS)


A 24-Week, Multicenter, Double-Blind, Randomized, Parallel-Group, Dose Ranging Study of the Efficacy and Safety of Oral Doses of XXX and Placebo on Top of an Established Treatment Regimen of XXX Monotherapy in the Treatment of Cognitive Impairment in Schizophrenia



Sleep and RLS Sample Metrics




A Phase IIIb, Double-blind, Randomized, Placebo-controlled Study of XXX and its Effect on All-day Functioning and Quality of Life in Subjects with Moderate to Severe Idiopathic Restless Legs Syndrome


SITE

Device Study: Evaluation of an All-in-One Positive Airway Pressure System


A Phase II Randomized, Double-blind, Placebo-and Active-Comparator-Controlled Study of the Safety and Efficacy of XXX in Outpatients with Insomnia


A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center Crossover Study of XXX as a Daily Treatment for Excessive Daytime Sleepiness (EDS) associated with Narcolepsy


A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Efficacy and Safety of XXX in the treatment of Primary Insomnia


A One-Year Open-label, Flexible Dosage Extension Study to Assess the Safety and Continued Effectiveness of XXX Treatment in Children and Adolescents with Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome



Additional Sample Metrics




A Phase IV 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of XXX Fixed Dose Combination Versus XXX Monotherapy in Adolescents and Adults With Persistent Asthma

16 14 13 months

2013 Active

An Open-Label, Randomized, Multi-Center, Parallel-Arm Study to Assess the Safety and Tolerability of XXX 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily Subcutaneous Injections in Subjects with Relapsing-Remitting Multiple Sclerosis

7 6 2 weeks 2013 Active

A Phase III, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of XXX in Adults Aged 18-55 Years with Moderate to Severe Binge Eating Disorder


sites)

2013 Closed

Pilot Epilepsy Study to Evaluate a Baseline Prototype Device Designed to Collect ECG (Electrocardiogram) and Accelerometer Data


A Phase IV, Multi-national, Randomized, Double-blind , Placebo-controlled, Study to Evaluate the Efficacy and Safety of XXX Compared to Placebo for Smoking Cessation Through Reduction


A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Adaptive Study of the Safety and Efficacy of XXX in Adults with Alcohol Dependence



Placebo Response Data - ADHD





ADHD Add-On Non-Stimulant Therapy to Psychostimulant Phase III Study: Mean Change from Baseline to Endpoint in ADHD-RS-IV Score

-25

-20

-15

-10

-5

0

0 (Baseline) 1 2 3 4 5 (Completion)Weeks

Ch

an

ge

fro

m B

ase

line

Placebo: Mean Change = -14.9 Investigational Compound: Mean Change = -22.3




Placebo Response Data - Bipolar

Florida Clinical Research Center, LLC (Site: Maitland, FL)Bipolar Depression Phase III Study: Mean Change from Baseline to Endpoint in

MADRS Score

Placebo, 0

-12.25 -12.2

-15

-10

-5

0

Treatment Group

Ch

ang

e F

rom

Bas

elin

e

Placebo Low dose High Dose


Placebo Response Data - GAD


Placebo Response Data - MDD

MDD Phase IIA Study: Mean Change from Baseline to Endpoint in MADRS Score

-15

-10

-5

0

5

0 1 2 3 4

Placebo: Mean Change = -2.0

Investigational Compound: Mean Change = -13.5

Comparator: Mean Change = -12.0



MDD Phase II Study: Mean Change from Baseline to Endpoint in MADRS Score

-25

-20

-15

-10

-5

0

0 1 2 4 6 8

Weeks

Ch

an

ge

fro

m B

ase

line

Placebo: Mean Change = -5.0 Investigational Compound: Mean Change = -21.5






Placebo Response Data - Schizophrenia










Database #s By Indication

IndicationCNSN

LA/Orange County

PRP Oakland/ San

Francisco

FSTAustin

FST Dallas

FCRC Maitland

FCRC Bradenton

Psychiatry

Addiction 800 800 1,000 600Access to alcohol,

smoking, binge eating

Access to alcohol,

smoking, binge eating

Bipolar 1,600 Treats 50/mth 1,000 1,000 1,000 2,200

Depression (incl. TRD) 2,500 Treats 100/mth 2,000 2,000 1,150 2,500

Post Traumatic Stress Disorder & Panic 200 n/a 350 200 150 120

Schizophrenia 2,900 Treats 500+/mth 1000 500 150 2,000

ADHD – adult n/a 200 2,500 400 1,000 1,500


Database #s By Indication (cont’d)

IndicationCNSN

LA/Orange County

PRP Oakland/ San

Francisco

FSTAustin

FST Dallas

FCRC Maitland

FCRC Bradenton

Neurology

Alzheimer’s 1,250 50 50 300 80 n/a

Alzheimer’s – Mild Cognitive Impairment 175 50 50/mth 500 100 n/a

Epilepsy – Mild to Severe Seizures 850 n/a 350 n/a n/a n/a

Multiple Sclerosis 245 n/a 70 n/a n/a n/a

Parkinson’s 900 n/a 110 n/a n/a n/a

Stroke 900 n/a 175 n/a n/a n/a

Traumatic Brain Injury 275 n/a 200 n/a n/a n/a


IndicationCNSN

LA/Orange County

PRP Oakland/ San

Francisco

FSTAustin

FST Dallas

FCRC Maitland

FCRC Bradenton

Pain

Chronic (back/knee/hip) 1,475 n/a 2,000 1,000 50 50

DPN/Neuropathy (diabetic, non-diabetic, polyneuropathy) & PHN 1,200 n/a 1,250 100 50 n/a

Fibromyalgia 400 100 1,500 1,700 250 250

Osteoarthritis (general incl knee and hip) 300 n/a 900 50 100 200

Migraine 500 Future indication 1,100 500 200 80

Opioid Induced Constipation 150 Future indication 100 100 n/a n/a

Rheumatoid Arthritis 175 n/a 260 n/a n/a n/a

Sleep Disorders

Adult Insomnia n/a Future indication 1,750 100 300 1571

Elderly Insomnia n/a n/a 750 100 150 25

Restless Legs Syndrome 400 n/a 1,800 100 n/a n/a




IndicationCNSN

LA/Orange County

PRP Oakland/ San

Francisco

FSTAustin

FST Dallas

FCRC Maitland

FCRC Bradenton

General Medical n/a

Acid Reflux 1,000 n/a n/a 200 200

Constipation 130 n/a n/a 300 300

COPD/ Asthma 200 200 n/a 100 150

Diabetes 2,100 500 250 500 500

High Cholesterol 1,100 500 250 700 500

Hypertension/ Hyperlipidemia 1,050 1,000 100 600 400

Irritable Bowel Syndrome/Disorder 150 100 n/a 50 400

Men’s/Women’s Health 1,350 250 n/a 500 1,200

Obesity 1,350 100 100 740 1,000


Sponsor Relations Team

Jeanette Caruso Finance Manager

Bobbie TheodoreAlliance Director

[email protected](866) 669-0234

Annie SpenoOperations Manager

Expedited feasibility and budget/contract negotiation handled by single point of contact with Sponsor Relations Team. Our team is responsible for handling the business development needs of the group, sponsor and CRO relations, facilitating the site selection process (CDAs, feasibility questionnaires, CVs, site capabilities information), budgets and contracts, keeping in regular contact for feedback and garnering new study opportunities so the site personnel can focus on their studies in process. There is no charge to sponsors or CROs for these services.

mailto:[email protected]

Documents

Clinical Trial Centers Alliance