Transcript FutureSearch Trials of Neurology & Sleep Lab 5508 Parkcrest Drive, Suite 310, Austin, TX 78731 Presented By Bobbie Theodore Alliance Director [email protected] www.clinicaltrialcenters.com.

FutureSearch Trials of Neurology
&
Sleep Lab
5508 Parkcrest Drive, Suite 310, Austin, TX 78731
Presented By
Bobbie Theodore
Alliance 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
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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
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PI Highlights
John Douglas Hudson, M.D.
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.
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Staff Highlights
 Highly Experienced Staff
 Dr. Hudson’s sleep lab manager, Jim Spector, is a Registered Polysomnographic
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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 Experience
 Sleep Disorders 50+ studies, inpatient PSG and outpatient
10+ PSG studies – insomnia, restless legs syndrome
50+ 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
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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
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 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
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 Autonomic Dysfunction and Hypertension in RLS patients
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Experience 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
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, PharmD
Sr. Regional Medical Scientist, Neuroscience/Urology
Clinical 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
Rating Experience Includes:
ADAS-COG
ADCS
ACDS
AIMS
AISRS/ADHD RS-IV
ASEX
BACS
BAI
BARS
BAS
BDI
BPI-SF
BPRS
BSS
CAI
CANTAB
CAARS
CADSS
CDR
CDR-SOB
CDSS
CGI-BP/I/S/SCA-S
CIBIC
COG STATE
CPRS
CPT
CRTT
C-SSRS
DAD
DCSQ
DESS
DS
DSM-IV Diagnosis
DSST
ESRS
ESS
FAQ
FAST
FIQ
FMS
FOSQGAF
GAS
GBI
HAM-A
HAM-D
HIS
HUI
ISI
KBIT
K-SADS
LSEQ
MADRS
MATRICS
MCCB (Matrics)
MGH ATRQ
MINI
MMSE
MOS
MOS-SS
MSLT
NAB
NPI
NSA
Certified, experienced raters, including M.D., Ph.D. and M.A.-level
NTB
NYPRS
PANSS
PDQ
PGA
POMS
PQAS
PSP
PSQI
PUTS
PWI
QIDS-16
Q-LES-Q
RAVLT
RSQ – D/W
RUD-Lite
RUSP
RUQ
SANS
SAS
SASS
SBQ-R
SCID
SCL-90
SCoRS
SDS
SQLM
SRTT
STS
SWN
TMTP 1, 2
TSSR
UPDRS
VAS
WCST
WMS
WOMAC
WPAI
WTAR
UPSA
YBOCS
YGTSS
YMRS
Research Quality
 Organizational Commitment
 Dedicated internal QA function at each site
 Site-based internal training programs
 Publications, advisory board membership and protocol consulting roles
 Outcomes
 Numerous Sponsor and CRO audits with favorable feedback
 Separation from placebo
 Top enroller sleep disorders and RLS
Sleep Sample Metrics
# of
Patients
Screened
# of Patients
Randomized
Length of
Enrollment
Year
Met
Target ?
74
16 (national
average)*
10 months
2011
Yes
A Phase II Randomized, Double-blind, Placeboand 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, Placebocontrolled, 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
Study Title
A Phase III, Multicenter, Randomized, DoubleBlind, Placebo-Controlled, Parallel Group,
Polysomnography Study to Evaluate the Safety and
Efficacy of XXX in [adults and] Elderly Patients
with Primary Insomnia
*Sponsor approved site to enroll more elderly patients as they exceeded their target
Sleep Sample Metrics (cont’d)
# of
Patients
Screened
# of Patients
Randomized
Length of
Enrollment
Year
Met
Target ?
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, Placebocontrolled, 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
Study Title
Sleep Sample Metrics (cont’d)
# of
Patients
Screened
# of Patients
Randomized
Length of
Enrollment
Year
Met
Target ?
A Multi-center, Randomized, Double-blind, Placebocontrolled, 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, PlaceboControlled, 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
Study Title
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
 Jesse Loudin, M.Ed., CCRC – Director of Clinical Research
Contact Info
 Website: www.clinicaltrialcenters.com
 For more information please contact Alliance Team:
Bobbie Theodore – Alliance Director
[email protected] email
(866) 669-0234 or (916) 939-6696
Annie Speno – Operations Manager
[email protected] email
916-934-0569 phone / 866-745-8708 fax
Jeanette Caruso – Site Liaison & Budgets/Contracts Manager
[email protected] email
916-933-3023 phone / 916-933-3097 fax