FutureSearch Trials of Neurology & Sleep Lab 5508 Parkcrest Drive, Suite 310 Austin, TX 78731...

FutureSearch Trials of Neurology & Sleep Lab

5508 Parkcrest Drive, Suite 310Austin, TX 78731

Presented ByBobbie TheodoreAlliance Director

[email protected]

www.clinicaltrialcenters.com

Site Highlights

Dedicated Research Site – Established in 2000

A full time research facility in Austin, TX, distinguished for expertise in sleep medicineLarge sleep practice and sleep lab on premises of research facility with 6 beds dedicated to researchEarly phase through phase IV, including proof of concept, PK, dose-ranging, EEG monitoringCentral IRBLarge 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 treatmentCapable of electronically sending PSG reports via a secured serverFull time dedicated site recruitment specialists meet targeted quality enrollment swiftly via research and practice databases, community outreach, and established referral systemFull time research, regulatory, QA, training & IT staff


Site Highlights

FacilityFutureSearch 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 weekCertified 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 MedicinePrincipal Investigator and Private Practitioner40 years treatment experience, 10+ years investigator experience, 100+ clinical trials including sleep, pain and neurology disordersPSG 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 facilityAdult and elderly PSG studies as well as outpatient, diary sleep studies

John Douglas Hudson, M.D.

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.


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 trialsTechnicians are trained in good clinical practices and sleep study procedures, and undergo study specific training on a monthly basisDoctorate-level clinical raters with experience in a variety of sleep, pain and movement scalesExperienced full time dedicated CCRCs, 2 RNs, 2 MDs and a PA who serve as Sub-I’sExtensive experience using and instructing patients in the use of Actigraphy


Trial Experience

Sleep Disorders : 50+ studies, inpatient PSG and outpatient 15+ PSG studies – insomnia, restless legs syndrome50+ Sleep disorder studies – insomnia, narcolepsy, OSA, shift worker, restless legs syndrome, non-restorative sleep, delayed sleep phase syndrome, obstructed sleep apnea, excessive sleepiness associated with OSA/ hypopnea with comorbid MDD or dysthymic disorder

Pain & Neurology: 35+ studies, broad range of indications30+ Pain studies – fibromyalgia, diabetic neuropathy, post herpetic neuralgia, low back pain, migraine, OA8+ Neurology studies – Parkinson’s, epilepsy, Multiple Sclerosis, TBI, Alzheimer’s

Other: 5+ studies, broad range of indicationsCOPD, asthma, tinnitus, pharmacogenomics, flexible dose, stuttering, PDS


Additional Interests & Experience

Phase IDr. Hudson is interested in Phase I Studies and has been Investigator on 15-20 intensive PK studies (pharmacokinetics), 1-5 PD studies (pharmacodynamics), 15-20 PG studies (pharmacogenomics)

Pain StimulationExperience with testing auditory thresholds during sleepExperience with hundreds of patients in sleep lab who suffer from pain syndromesUnderstand the relationship between pain and sleep staging and arousal patternsUnderstand how to measure arousals and alterations of sleep architectureDEA licensed, experienced and comfortable with schedule II drugs in clinical trials

End Stage Renal Disease from a Sleep or RLS standpointAffiliated with a large outpatient renal dialysis unitTwo urologists contracted to serve as Sub-Is

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


Device Experience

Dr. 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 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

TestimonialsHello 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


Testimonials

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

Bobbie,Please pass my gratitude on to Dr. Hudson and staff as they have really knocked a good many missing pages out (before deadline), I am very impressed. Other sites were not close to meeting this deadline. Please share my gratitude with Dr. Hudson next time you speak to him. I know Adam put a lot of time into this and it should not go unsung. Thank you.


Rating Experience Includes:ADAS-COGADCSACDSAIMSAISRS/ADHD RS-IVASEXBACSBAIBARSBASBDIBPI-SFBPRSBSSCAICANTABCAARSCADSSCDRCDR-SOBCDSS

CGI-BP/I/S/SCA-SCIBICCOG STATECPRSCPTCRTTC-SSRSDADDCSQDESSDSDSM-IV DiagnosisDSSTESRSESSFAQFASTFIQFMSFOSQGAFGAS

GBIHAM-AHAM-DHISHUIISIKBITK-SADSLSEQMADRSMATRICSMCCB (Matrics)MGH ATRQMINIMMSEMOSMOS-SSMSLT NABNPINSA

NTBNYPRSPANSSPDQPGAPOMSPQASPSPPSQIPUTSPWIQIDS-16Q-LES-QRAVLTRSQ – D/WRUD-LiteRUSPRUQSANSSASSASS

SBQ-RSCIDSCL-90SCoRSSDSSQLMSRTTSTSSWNTMTP 1, 2TSSRUPDRSVASWCSTWMSWOMACWPAIWTARUPSAYBOCSYGTSSYMRS

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


Research Quality

Organizational CommitmentDedicated internal QA function at each site Site-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 Screened

# of Patients Randomized

Length of Enrollment Year Status

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

16 7 2 months 2012 Active

XXX Geo Study: Evaluation of an All-in-One Positive Airway Pressure System 10 10 1 month 2011 Closed

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

74 16 (national average)* 10 months 2011 Closed

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 Closed

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


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


Sleep Sample Metrics (cont’d)

Study Title# of

Patients Screened



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 Closed

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


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


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


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 Closed


Sleep Sample Metrics (cont’d)

Study Title# of

Patients Screened



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 Legs Syndrome


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


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


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


Additional therapeutic area metrics available upon request


Recent Sleep Protocols

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

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

Greg Tempest, M.D. – Sub-I

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

*Multiple study coordinators and doctorate-level raters on staff, CVs available upon request

http://www.box.net/shared/12hx6bkcs4

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http://www.box.net/shared/drm3l2pg8c



http://www.box.com/s/0fb7c00cef20edc41b57

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Sponsor Relations Team

Jeanette Caruso Budgets/Contracts 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 Site 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), 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]

FutureSearch Trials of Neurology & Sleep Lab 5508 Parkcrest Drive, Suite 310 Austin, TX 78731...

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