FutureSearch Trials of Neurology &

Sleep Lab5508 Parkcrest Drive, Suite 310, Austin, TX 78731

Presented By

Bobbie TheodoreAlliance Director

clinicaltrials@btheodore.comwww.clinicaltrialcenters.com

Site HighlightsDedicated Research Site – Established in 2000

A full time research facility in Austin, TX, distinguished for expertise in Sleep Medicine

Large sleep practice and sleep lab on premises of research facility with 6 beds dedicated to research

Early Phase through Phase IV, including Proof of Concept, PK, Dose-Ranging, EEG monitoring

Central IRB Large site database of 30,000 sleep disorder patients and large

practice database of over 2,500 sleep, pain and neurology disorder patients, accumulated over the last 40 years of treatment

Capability to electronically send PSG reports via a secured server Full time dedicated Site Recruitment Specialists meet targeted quality

enrollment swiftly via database, community outreach, and established referral system

Full time Research, Regulatory, QA, Training & IT Staff

Site Highlights Facility

FutureSearch Trials Sleep Lab, is a 6-bed facility designed and fully outfitted specifically for clinical trials in operation 24 hours a day, 7 days/nights per week

Certified by both Clinilabs and Henry Ford Hospital Sleep Center for Sleep Study Collection and by Clinilabs for Electronic Data Transfer

PI Highlights

Double Board Certified Neurology and Sleep Medicine Principal Investigator and Private Practitioner 40 years treatment experience, 9+ years Investigator

Experience, 100+ clinical trials including sleep, pain and neurology disorders

PSG and Sleep Disorder Thought Leader – provides protocol training and consulting

Dr. Hudson’s neurology practice and sleep lab is located on premises of the FutureSearch research facility where he has conducted over 100 clinical trials

Adult and elderly PSG studies as well as outpatient, diary sleep studies.

Dr. Hudson is the Founder and President of Sleep Medicine Consultants and is the primary sleep specialist in the Austin, TX area. He maintains strong relationships with other area sleep disorder clinics, community hospitals, residential facilities, and physician practices for additional recruitment. 

Dr. Hudson has been a top enroller on PSG and outpatient sleep disorder studies for the past 9 years, enrolling approximately 10 subjects per month. He is a preferred pharma and CRO site.

John Douglas Hudson, M.D.

Staff Highlights Highly Experienced Staff

Dr. Hudson’s sleep lab manager, Jim Spector, is a Registered Polysomnographic Technologist (RPSGT) and Certified Clinical Research Coordinator certified by both Clinilabs and Henry Ford Hospital Sleep Center as a scoring technologist, with 30 years experience, and more than 5 years experience conducting PSG clinical trials.

Technicians are trained in Good Clinical Practices and Sleep Study Procedures, and undergo study specific training on a monthly basis

Masters, Ph.D., and M.D. level Clinical Raters with experience in a variety of sleep, pain and movement scales

Experienced full time dedicated Certified Clinical Research Coordinators including 2 RNs, 2 MDs and a PA who serve as Sub-I’s

Extensive experience using and instructing patients in the use of Actigraphy

Trial ExperienceSleep Disorders 50+ studies, inpatient PSG and

outpatient10+ PSG studies – insomnia, restless legs syndrome50+ Sleep Disorder studies – insomnia, narcolepsy, OSA, shift worker, restless legs syndrome, non-restorative sleep, delayed sleep phase syndrome, excessive sleepiness associated with OSA/Hypopnea with Comorbid MDD or Dysthymic Disorder

Pain & Neurology 35+ studies, broad range of indications 30+ Pain studies – fibromyalgia, diabetic neuropathy, post herpetic neuralgia, low back pain 8+ Neurology studies – Parkinson’s, epilepsy, Multiple Sclerosis, TBI

Other 5+ studies, broad range of indications 5+ Other – COPD, tinnitus, Pharmacogenomics, flexible dose, stuttering, PDS

Additional Interests & Experience

Phase I Dr. Hudson is interested in Phase I Studies and has been Investigator on 15-20

PK studies (pharmacokinetics), 1-5 PD studies (pharmacodynamics), 15-20 PG studies (pharmacogenomics)

Pain Stimulation Experience with testing auditory thresholds during sleep Experience with hundreds of patients in sleep lab who suffer from pain

syndromes Understand the relationship between pain and sleep staging and arousal

patterns Understand how to measure arousals and alterations of sleep architecture

End Stage Renal Disease from a Sleep or RLS standpoint Affiliated with a Large Outpatient Renal Dialysis Unit Two Urologists to serve as Sub-Is

Autonomic Dysfunction and Hypertension in RLS patients Experience and understanding of issues with autonomic testing of sleep

patients

Device ExperienceDr. Hudson has been in the sleep world since 1979 when CPAP first came on the

scene. His site has tested various CPAPs and designed their own polysomnogram unit, as there was nothing of its kind commercially available at the time.

He began utilizing the Vagal Nerve Stimulator for epilepsy patients in the 1980s and has about 25 patients with the devices implanted. While the device is not for sleep, a recent report shows that VNS often worsens sleep apnea. They are, therefore, more attentive to that issue. Currently, VNS is being studied to treat fibromyalgia and FutureSearch has done many fibro trials. All FutureSearch staff are familiar with the VNS and know how to interrogate and adjust the settings.

Dr. Hudson has done penile tumescent sleep studies for male impotence using a variety of devices, and has been involved with the devices used to more or less microwave the soft palate in hopes it would help obstructive sleep apnea (somnoplasty).

FutureSearch has also tested Alpha Stim/ Cerebral Electrical Stimulation

Testimonials Hello all,I just wanted to congratulate you on your screening efforts so far for the XXX study. Based on XXX, it looks like your site has screened 21 subjects through today. That puts your site as one of the highest screening sites in the study.We appreciate all the work you have done so far. Your site continues to be responsive to emails and phone calls. Also, your data is entered into the XXX in a timely manner and the queries are addressed quickly.Thanks again and please let me know if you need anything.Sincerely,xxx, Clinical Research Associate

Dear Dr. Hudson,I hope you are doing well. I was reviewing the XXX-sponsored trial enrollment numbers in my region (So. Texas), and I was impressed with your enrollment numbers in the XXX Polysomnography study (XXX). I just wanted to say thank you so much for all of the hard work by you and your staff!Sincerely,xxx, PharmDSr. Regional Medical Scientist, Neuroscience/UrologyClinical Development & Medical Affairs

Dr. Hudson, Jessie and Kevin,We are impressed with your site’s level of activity! We talk of you often to the sponsor. We are glad that we chose you as a site to participate in this study. We are tracking on timelines for the end of enrollment. We would not be able to do that if it were not for sites like yours.Kind regards,xxx, RN MSN, Clinical Trial Manager

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Rating Expertise Includes:

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

Research QualityOrganizational Commitment

Dedicated internal QA function at each siteSite-based internal training programsPublications, advisory board membership and protocol

consulting roles

OutcomesNumerous Sponsor and CRO audits with favorable feedbackSeparation from placeboTop enroller sleep disorders and RLS

Sleep Sample Metrics

Study Title

# of Patients Screen

ed

# of Patients

Randomized

Length of Enrollmen

t Year

MetTarget

?

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Polysomnography Study to Evaluate the Safety and Efficacy of XXX in [adults and] Elderly Patients with Primary Insomnia

7416 (national average)*

10 months 2011 Yes

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

28 21 4 months 2009 Yes

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

14 11 6 months 2009 Yes

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

15 10 1 month 2007 Yes

*Sponsor approved site to enroll more elderly patients as they exceeded their target

Sleep Sample Metrics (cont’d)

Study Title

# of Patients Screen

ed

# of Patients

Randomized

Length of Enrollmen

t Year

MetTarget

?

A Randomized, Double-blind, Placebo-controlled Study to Determine the Long-Term Efficacy and Safety of XXX in Adults with Chronic Insomnia

10 10 4 months 2007 Yes

A Six-week, Double-blind, Randomized, Placebo-controlled, Parallel-group, Efficacy and Safety, Sleep Lab Trial with XXX in Patients with Chronic Primary Insomnia

33 12 6 months 2007 Yes

A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of XXX in Patients with Restless Leg Syndrome

34 19 7 months 2006 Yes

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

6 5 1 month 2006 Yes

Sleep Sample Metrics (cont’d)

Study Title

# of Patients

Screened# of Patients Randomized

Length of Enrollment Year

MetTarget ?

A Multi-center, Randomized, Double-blind, Placebo-controlled, Five-Arm Parallel-Group Trial to Investigate the Efficacy and Safety of Four Different Transdermal Doses of XXX in Subjects with Idiopathic Restless Leg Syndrome

29 19 7 months 2005

Yes

A Randomized, Double-blind, Comparison of XXX, XXX, and Placebo in the Treatment of Patients with Primary Insomnia

31 18 7 months 2005

Yes

A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Tolerability of XXX in Improving Clinical Condition Late in the Shift and in Improving Functional and Patient-Reported Outcomes in Adult Patients with Excessive Sleepiness Associated with Shift Work Disorder

7 7 4 months 2004

Yes

A Phase III, Randomized, Double-blind, Placebo-Controlled, PSG Plus Outpatient Study to Determine the Safety and Efficacy of XXX in Adults with Chronic Insomnia and A Phase III, Open-label, Fixed-dose Study to Determine the Safety of Long Term Administration of XXX in Subjects with Chronic Insomnia

22 20 6 months 2003

Yes

Additional therapeutic area metrics available upon request

Recent Sleep ProtocolsA Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group,

Polysomnography Study to Evaluate the Safety and Efficacy of XXX in [adults and] Elderly Patients with Primary Insomnia

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Tolerability of XXX Treatment in Improving Clinical Condition Late in the Shift and in Improving Functional and Patient-Reported Outcomes in Adult Patients With Excessive Sleepiness Associated With Shift Work Disorder

A Fixed Dose Randomized, Double-blind, 12-Week Study of XXX in Subjects with Moderate to Severe Idiopathic Restless Legs Syndrome

A 12 week, randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage, Study to Evaluate the Efficacy and Safety of XXX as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury

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

A Randomized Double-Blind, Placebo-Controlled, 3-Way Crossover, Multicenter Polysomnography Study of XXX and XXX in Adults with Restless Legs Syndrome

Curriculum Vitae

Click on names to view CVs:

John Douglas Hudson, M.D. – PI

Donald J. Garcia, M.D. – PI

Jim Spector - Sleep Lab Manager

Jesse Loudin, M.Ed., CCRC – Director of Clinical Research

Contact InfoWebsite: www.clinicaltrialcenters.com

For more information please contact Alliance Team:

Bobbie Theodore – Alliance Directorclinicaltrials@btheodore.com email(866) 669-0234 or (916) 939-6696

Annie Speno – Operations Managerannie@btheodore.com email916-934-0569 phone / 866-745-8708 fax

Jeanette Caruso – Site Liaison & Budgets/Contracts Manager

jeanette@btheodore.com email916-933-3023 phone / 916-933-3097 fax