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FutureSearch Trials of Neurology & Sleep Lab 5508 Parkcrest Drive, Suite 310 Austin, TX 78731 Presented By Bobbie Theodore Alliance Director

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Presentation on theme: "FutureSearch Trials of Neurology & Sleep Lab 5508 Parkcrest Drive, Suite 310 Austin, TX 78731 Presented By Bobbie Theodore Alliance Director"— Presentation transcript:

1 FutureSearch Trials of Neurology & Sleep Lab 5508 Parkcrest Drive, Suite 310 Austin, TX Presented By Bobbie Theodore Alliance Director

2 Site Highlights Dedicated 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 Capable of electronically sending PSG reports via a secured server Full time dedicated site recruitment specialists meet targeted quality enrollment swiftly via research and practice databases, community outreach, and established referral system Full time research, regulatory, QA, training & IT staff

3 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

4 PI Highlights Double Board Certified Neurology and Sleep Medicine Principal Investigator and Private Practitioner 40 years treatment experience, 10+ years investigator experience, 100+ clinical trials including sleep, pain and neurology disorders PSG and sleep disorder thought leader – provides protocol training and consulting Dr. Hudsons neurology practice and sleep lab is located on premises of the FutureSearch research facility Adult 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.

5 Staff Highlights Highly Experienced Staff Dr. Hudsons 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 Doctorate-level clinical raters with experience in a variety of sleep, pain and movement scales Experienced full time dedicated CCRCs, 2 RNs, 2 MDs and a PA who serve as Sub-Is Extensive experience using and instructing patients in the use of Actigraphy

6 Trial Experience Sleep Disorders : 50+ studies, inpatient PSG and outpatient 15+ 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, obstructed sleep apnea, 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, migraine, OA 8+ Neurology studies – Parkinsons, epilepsy, Multiple Sclerosis, TBI, Alzheimers Other: 5+ studies, broad range of indications COPD, asthma, tinnitus, pharmacogenomics, flexible dose, stuttering, PDS

7 Additional Interests & Experience Phase I Dr. Hudson is interested in Phase I Studies and has been Investigator on intensive PK studies (pharmacokinetics), 1-5 PD studies (pharmacodynamics), 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 DEA licensed, experienced and comfortable with schedule II drugs in clinical trials End Stage Renal Disease from a Sleep or RLS standpoint Affiliated with a large outpatient renal dialysis unit Two urologists contracted to serve as Sub-Is Autonomic Dysfunction and Hypertension in RLS patients Experience and understanding of issues with autonomic testing of sleep patients

8 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

9 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 s 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

10 Testimonials Dr. Hudson, Jessie and Kevin, We are impressed with your sites 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.

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

12 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

13 Sleep Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of Enrollment YearStatus A Phase I, Inpatient Multicenter, Open-Label Study to Determine the Effects of XXX on Sleep in Healthy Subjects 1672 months2012Active XXX Geo Study: Evaluation of an All-in-One Positive Airway Pressure System 10 1 month2011Closed 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 (national average)* 10 months2011Closed A Phase II Randomized, Double-blind, Placebo-and Active- Comparator-Controlled Study of the Safety and Efficacy of XXX in Outpatients with Insomnia months2009Closed 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 months2009Closed *Sponsor approved site to enroll more elderly patients as they exceeded their target

14 Sleep Sample Metrics ( contd ) Study Title # of Patients Screened # of Patients Randomized Length of Enrollment YearStatus A Multi-center, Randomized, Double-blind, Placebo- controlled, Parallel Study to Investigate the Efficacy and Safety of XXX in the treatment of Primary Insomnia month2007Closed A Randomized, Double-blind, Placebo-controlled PSG Study to Determine the Long-Term Efficacy and Safety of XXX in Adults with Chronic Insomnia 10 4 months2007Closed A Six-week, Double-blind, Randomized, Placebo- controlled, Parallel-group, Efficacy and Safety, Sleep Lab Trial with XXX in Patients with Chronic Primary Insomnia months2007Closed A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of XXX in Patients with Restless Legs Syndrome months2006Closed 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 651 month2006Closed

15 Sleep Sample Metrics ( contd ) Study Title # of Patients Screened # of Patients Randomized Length of Enrollment YearStatus 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 months2005Closed A Randomized, Double-blind, Comparison of XXX, XXX, and Placebo in the Treatment of Patients with Primary Insomnia months2005Closed 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 774 months2004Closed 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 months2003Closed Additional therapeutic area metrics available upon request

16 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

17 Curriculum Vitae Click on names to view CVs * : John Douglas Hudson, M.D. John Douglas Hudson, M.D. – PI Donald J. Garcia, M.D. Donald J. Garcia, M.D. – PI Jim Spector Jim Spector – Sleep Lab Manager Greg Tempest, M.D.Greg Tempest, M.D. – Sub-I Jesse Loudin, M.Ed., CCRC Jesse Loudin, M.Ed., CCRC – Director of Clinical Research *Multiple study coordinators and doctorate-level raters on staff, CVs available upon request

18 Sponsor Relations Team Jeanette Caruso Budgets/Contracts Manager Bobbie Theodore Alliance Director (866) Annie Speno Operations 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.


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