Clinical Trials Performed

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Clinical Trials Performed

  1. A Nine Week Placebo-Controlled, Double-Blind, Randomized, Parallel-group study of the efficacy of two fixed doses (200 mg, 400 mg) of oral Modafinil in patients with Narcolepsy; followed by An 40 week, open-label, flexible-dose continuation study, followed by recurrent 48 week open-label extensions; 1994-1999. Principal Investigator: R. Bart Sangal, M.D. Supported by Cephalon, Inc.
  2. Cognex: Neuropsychiatric Testing and Assessment of Caregiver Time Study; 1996. Principal Investigator: R. Bart Sangal, M.D. Supported by Parke-Davis Medical Research.
  3. A Double-Blind Flexible Dose Study of Transdermal Buspirone in the Treatment of Children with Attention-Deficit Hyperactivity Disorder; 1997-1998. Principal Investigator: R. Bart Sangal, M.D. Supported by Bristol-Myers Squibb Co.
  4. A Double-Blind Fixed Dose Study of Transdermal Buspirone in the Treatment of Children with Attention-Deficit Hyperactivity Disorder; followed by An Open-Label, Long Term, Flexible Dose Safety Study of Transdermal Buspirone in the Treatment of Childhood Attention-Deficit Hyperactivity Disorder; 1998. Principal Investigator: R. Bart Sangal, M.D. Supported by Bristol-Myers Squibb Co.
  5. An Open-Label, Long Term, Flexible Dose Safety Study of Transdermal Buspirone in the Treatment of Childhood Attention-Deficit Hyperactivity Disorder; 1997-1998. Principal Investigator: R. Bart Sangal, M.D. Supported by Bristol-Myers Squibb Co.
  6. The Pharmacokinetics of Buspirone during Transdermal Administration to Children with Attention-Deficit Hyperactivity Disorder, with and without RitalinR Therapy; 1998. Principal Investigator: R. Bart Sangal, M.D. Supported by Bristol-Myers Squibb Co.
  7. A Six-Week Open-Label Study of Safety and Efficacy of ProvigilR (Modafinil) in patients switching from stimulant therapy for Narcolepsy-associated Excessive Daytime Sleepiness; 1998-1999. Principal Investigator: R. Bart Sangal, M.D. Supported by Cephalon, Inc.
  8. A Double-Blind, Randomized, Parallel-Design, Placebo-Controlled Trial of d-threo-Methylphenidate Hydrochloride (d-MPH) and dl-threo-Methylphenidate Hydrochloride (dl-MPH) in Children with Attention Deficit Hyperactivity Disorder (ADHD); 1999. Principal Investigator: R. Bart Sangal, M.D. Supported by Celgene Corporation.
  9. A Double-Blind, Randomized, Parallel-Design, Placebo-Controlled Withdrawal Trial of d-threo-Methylphenidate Hydrochloride (d-MPH) in Children with Attention Deficit Hyperactivity Disorder (ADHD) Who Are Responding to d-MPH; 1999. Principal Investigator: R. Bart Sangal, M.D. Supported by Celgene Corporation.
    A Six Month Open-Label Safety Trial of d-threo-Methylphenidate Hydrochloride (d-MPH) in Children with Symptoms of Attention Deficit Hyperactivity Disorder (ADHD); 1999. Principal Investigator: R. Bart Sangal, M.D. Supported by Celgene Corporation.
  10. A Six Month Open-Label Safety Trial of d-threo-Methylphenidate Hydrochloride (d-MPH) in Children with Symptoms of Attention Deficit Hyperactivity Disorder (ADHD); 1999. Principal Investigator: R. Bart Sangal, M.D. Supported by Celgene Corporation.
  11. A Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study evaluating the efficacy and safety of Buspirone Hydrochloride (15-60 mg/day) in Children and Adolescents (aged 6 to 17) with Generalized Anxiety Disorder; 1999. Principal Investigator: R. Bart Sangal, M.D. Supported by Bristol-Myers Squibb Co.
  12. A Double-Blind, Placebo-Controlled, Multi-Center, Randomized, Parallel-Group study of the effect of four weeks of Provigil (Modafinil) treatment on Excessive Daytime Sleepiness in Obstructive Sleep Apnea Patients treated with Nasal Continuous Positive Airway Pressure; 1999. Principal Investigator: R. Bart Sangal, M.D. Supported by Cephalon, Inc.
  13. A Double-Blind, Placebo-Controlled Study of Modified Release (MR) Methylphenidate in Children with ADHD; 1999. Principal Investigator: R. Bart Sangal, M.D. Supported by Medeva Development.
  14. A Phase III Open-Label Safety and Efficacy Study of Tomoxetine Hydrochloride in Outpatients with ADHD, Ages 6 to 18 years; 2000-2002. Principal Investigator: R. Bart Sangal, M.D. Supported by Lilly.
  15. A Phase III Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Comparison of Fixed-Dose Ranges (mg/kg/day) of Tomoxetine with Placebo in Child and Adolescent Outpatients with ADHD, Aged 8 to 18 years; 2000-2002. Principal Investigator: R. Bart Sangal, M.D. Supported by Lilly.
  16. A Multicenter, double-blind, randomized, placebo-controlled, parallel-group, evaluation of the safety and efficacy of a modified-release oral dosage form of Methylphenidate-HCl (Ritalin-QD) in children with ADHD; 2000. Principal Investigator: R. Bart Sangal, M.D. Supported by Novartis Pharmaceuticals Corporation.
  17. A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group study to evaluate the Safety and Efficacy of 12 weeks of 2 Oral Doses (200 mg and 400 mg once daily) of Provigil (Modafinil) as Treatment for Adults with Excessive Daytime Sleepiness associated with Obstructive Sleep Apnea/Hypopnea Syndrome followed by a 9-month open-label extension; 2000-2001. Principal Investigator: R. Bart Sangal, M.D. Supported by Cephalon, Inc.
  18. An Efficacy, Safety and Tolerability Study of (S)-Zopiclone in subjects with Transient Insomnia (First Night Effect Model); 2000-2001. Principal Investigator: R. Bart Sangal, M.D. Supported by Sepracor, Inc.
  19. A Phase III Randomized, Double-Blind Comparison of Placebo and Tomoxetine in Adult Outpatients with DSM-IV Attention-Deficit/Hyperactivity Disorder; 2000-2001. Principal Investigator: R. Bart Sangal, M.D. Supported by Lilly.
  20. A Long-Term, Open Label, safety study of Tomoxetine Hydrochloride in Patients, 6 Years and Older; 2000-2007. Principal Investigator: R. Bart Sangal, M.D. Supported by Lilly.
  21. A Randomized, Double-Blind, Placebo-Controlled, Single Dose First Night Effect Sleep Laboratory Study of Two Doses of TAK-375 in Health Adult Volunteers; 2000. Principal Investigator: R. Bart Sangal, M.D. Supported by Takeda America Research and Development Center, Inc.
  22. A Phase 3 Open-Label Safety and Efficacy Study of Tomoxetine Hydrochloride in Pediatric Outpatients (6 to 18 years) with ADHD; 2001. Principal Investigator: R. Bart Sangal, M.D. Supported by Lilly.
  23. A Long-Term, Open Label, safety study of Tomoxetine Hydrochloride in Adult Outpatients with DSM-IV Attention-Deficit/Hyperactivity Disorder; 2001-2007. Principal Investigator: R. Bart Sangal, M.D. Supported by Lilly.
  24. Efficacy, Tolerability, and Safety of Once-Daily Tomoxetine Hydrochloride versus Placebo in Children with Attention-Deficit/Hyperactivity Disorder; 2001. Principal Investigator: R. Bart Sangal, M.D. Supported by Lilly.
  25. Sleep and Cognitive/Neuropsychological Function in Children with Attention-Deficit/Hyperactivity Disorder Before and During Treatment with Tomoxetine Hydrochloride and Stimulants; 2001-2002. Principal Investigator: R. Bart Sangal, M.D. Supported by Lilly.
  26. A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study to assess the efficacy and safety of NBI-34060 in Elderly Patients with Chronic Insomnia, 2001. Principal Investigator: R. Bart Sangal, M.D. Supported by Neurocrine Biosciences, Inc.
  27. A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride, Extended-Release Methylphenidate Hydrochloride (Concerta), and Placebo in Pediatric Outpatients with DSM-IV Attention-Deficit/Hyperactivity Disorder, 2002-2003. Principal Investigator: R. Bart Sangal, M.D. Supported by Lilly.
  28. Comparison of efficacy and safety of Zolpidem_MR 12.5 mg and placebo in patients with primary insomnia. A double-blind, randomized, placebo-controlled, parallel-group study, 2002. Principal Investigator: R. Bart Sangal, M.D. Supported by Sanofi-Synthelabo.
  29. A Double-Blind Study of Treatment Optimization with Atomoxetine Hydrochloride in Adults with DSM-IV Attention-Deficit/Hyperactivity Disorder, 2002-2003. Principal Investigator: R. Bart Sangal, M.D. Supported by Lilly.
  30. A Randomized, Double-Blind, Active- and Placebo-Controlled 4-Way Crossover Study of the Safety and Efficacy of PD 0200390, Zolpidem, and Placebo in Primary Insomnia, 2002. Principal Investigator: R. Bart Sangal, M.D. Supported by Pfizer, Inc.
  31. A Phase III, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Determine the Safety and Efficacy of TAK-375 in Elderly Subjects with Chronic Insomnia, 2002-2003. Principal Investigator: R. Bart Sangal, M.D. Supported by Takeda Pharmaceuticals.
  32. A Phase III, Randomized, Double-Blind, Placebo-Controlled, PSG Plus Outpatient Study to Determine the Safety and Efficacy of TAK-375 in Adults with Chronic Insomnia, 2003. Principal Investigator: R. Bart Sangal, M.D. Supported by Takeda Pharmaceuticals.
  33. A Phase III, Open-Label, Fixed-Dose Study to Determine the Safety of Long-Term Administration of TAK-375 in Subjects with Chronic Insomnia, 2003-2004. Principal Investigator: R. Bart Sangal, M.D.,Supported by Takeda Pharmaceuticals.
  34. A 5-week, multicenter, double-blind, randomized, placebo-controlled, fixed-dose study of the efficacy and safety of FocalinTM LA (dexmethylphenidate hydrochloride extended-release capsules) administered once daily in adults with Attention-Deficit/Hyperactivity Disorder, 2003. Principal Investigator: R. Bart Sangal, M.D. Supported by Novartis Pharmaceuticals.
  35. A 6-month, open-label extension to a 5-week, multicenter, double-blind, randomized, placebo-controlled, fixed-dose study of the efficacy and safety of FocalinTM LA (dexmethylphenidate hydrochloride extended-release capsules) administered once daily in adults with Attention-Deficit/Hyperactivity Disorder, 2003. Principal Investigator: R. Bart Sangal, M.D. Supported by Novartis Pharmaceuticals.
  36. A 9-week, randomized, double-blind, placebo-controlled, flexible-dosage (up to 425 mg/day), parallel-group study to evaluate the efficacy and safety of Modafinil (Film-coated Tablet) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder, 2004. Principal Investigator: R. Bart Sangal, M.D. Supported by Cephalon, Inc.
  37. A 1-year, open-label, flexible-dosage study to evaluate the safety and continued efficacy of modafinil (Film-coated Tablet) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder, 2004-2006. Principal Investigator: R. Bart Sangal, M.D. Supported by Cephalon, Inc.
  38. A double-blind study of functional outcomes with Atomoxetine-Hydrochloride and Placebo in adult outpatients with DSM-IV Attention-Deficit/Hyperactivity Disorder, 2004-2006. Principal Investigator: R. Bart Sangal, M.D. Supported by Lilly.
  39. A randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of Gabitril (4, 6, 8, and 10 mg) treatment in adult patients with primary insomnia, 2004. Principal Investigator: R. Bart Sangal, M.D. Supported by Cephalon, Inc.
  40. A randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of Gabitril (2, 4, 6, and 8 mg) treatment in elderly patients with primary insomnia, 2004. Principal Investigator: R. Bart Sangal, M.D. Supported by Cephalon, Inc.
  41. A 12-month, open-label study to evaluate the safety and efficacy of Gabitril at dosages up to 10 mg/day in adults with primary insomnia, 2004. Principal Investigator: R. Bart Sangal, M.D. Supported by Cephalon, Inc.
  42. A 12-month, open-label study to evaluate the safety and efficacy of Gabitril at dosages up to 8 mg/day in elderly adults with primary insomnia, 2004-2005. Principal Investigator: R. Bart Sangal, M.D. Supported by Cephalon, Inc.
  43. A North American, 4-week, multicenter, phase IIB double-blind, placebo-controlled, randomized, multiple dose, parallel-group study of the efficacy and safety of 0.5 mg, 1.0 mg and 2.0 mg M100907 tablets in the treatment of sleep maintenance insomnia, 2004-2005. Principal Investigator: R. Bart Sangal, M.D. Supported by Aventis, Inc.
  44. Efficacy and Safety of Once-Daily Atomoxetine Hydrochloride in Adults with ADHD Over and Extended Period of Time (6 Months): With a Brief Evaluation of Executive Cognition, 2004-2005. Principal Investigator: R. Bart Sangal, M.D. Supported by Lilly.
  45. An Exploratory Open-Label Safety and Efficacy Study of Atomoxetine in the Treatment of Mild Obstructive Sleep Apnea, 2004-2006. Principal Investigator: R. Bart Sangal, M.D. Supported by Lilly.
  46. A randomized, 4-way cross-over, double-blind, placebo-controlled, multicenter dose-finding trial with three dosages of Org 50081 in patients with Primary Insomnia, 2004-2005. Principal Investigator: R. Bart Sangal, M.D. Supported by Organon.
  47. A double-blind, randomized, placebo-controlled, multicenter, 30-night polysomnographic study of MK-0928 in Elderly patients with Primary Insomnia, 2005-2006. Principal Investigator: R. Bart Sangal, M.D. Supported by Merck & Co., Inc.
  48. A double-blind, randomized, placebo-controlled, multicenter, 30-night polysomnographic study of MK-0928 in Adult patients with Primary Insomnia, 2005-2006. Principal Investigator: R. Bart Sangal, M.D. Supported by Merck & Co., Inc.
  49. A Phase III, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to assess the long term efficacy and safety of doxepin HCl in Primary Elderly Insomnia patients with sleep maintenance difficulties, 2006. Principal Investigator: R. Bart Sangal, M.D. Supported by Somaxon Pharmaceuticals, Inc.
  50. Efficacy, safety and tolerability of zolpidem in the treatment of children aged 6 to 17 years with ADHD-associated insomnia. A multicentre, randomized, double-blind, placebo-controlled study, 2006. Principal Investigator: R. Bart Sangal, M.D. Supported by Sanofi-Aventis.
  51. A 6-week, double-blind, placebo-controlled, parallel-group randomized-withdrawal study to evaluate the continued efficacy of modafinil treatment at dosages up to 425 mg/day in patients with Attention-Deficit/Hyperactivity Disorder who are responders to modafinil treatment, followed by a 12-month open-label extension period, 2006. Principal Investigator: R. Bart Sangal, M.D. Supported by Cephalon, Inc.
  52. A 28 day, polysomnographic and subjective assessment of GW679769, 10 and 30 mg, for the treatment of Primary Insomnia: A randomized, double-blind, parallel-group, placebo-controlled trial, 2006. Principal Investigator: R. Bart Sangal, M.D. Supported by Glaxo-Smith-Kline.
  53. A Randomized, double-blind comparison of placebo and atomoxetine hydrochloride given once a day in adults with Attention-Deficit/Hyperactivity Disorder: with a secondary examination of impact of treatment on family functioning, 2006-2008. Principal Investigator: R. Bart Sangal, M.D. Supported by Lilly.
  54. A Multi-Center, Randomized, Double-blind, Parallel Study of The Efficacy and Safety of Two Weeks of Dosing of Various Formulations and Doses of NG2-73 and Placebo for Sleep Initiation in Primary Insomniacs, 2006-2007. Principal Investigator: R. Bart Sangal, M.D. Supported by Neurogen.
  55. A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging study of the safety and efficacy of ABT-894 in adults with Attention Deficit-Hyperactivity Disorder (ADHD), 2007. Principal Investigator: R. Bart Sangal, M.D. Supported by Abbott.
  56. A Six-week, double-blind, randomized, placebo-controlled, parallel group, efficacy and safety, sleep lab trial with Org 50081 in patients with chronic primary insomnia, 2007. Principal Investigator: R. Bart Sangal, M.D. Supported by Organon.
  57. Fifty-two weeks, open-label extension trial to evaluate safety and efficacy of Org 50081 in outpatients with chronic primary insomnia who completed Clinical Trial Protocol 176001 or 176002, 2007-2008. Principal Investigator: R. Bart Sangal, M.D. Supported by Organon.
  58. A Phase II1, randomized, double-blind, placebo-controlled, incomplete-block, two-period crossover clinical trial to study the safety and efficacy of MK-0249 for adult patients, ages 18 to 55, with Attention Deficit Hyperactivity Disorder (ADHD), 2007-2008. Principal Investigator: R. Bart Sangal, M.D. Supported by Merck.
  59. A prospective, open-label, multi-center, dose-optimization study evaluating the efficacy, safety and tolerability of Vyvanse 20-70 mg in children aged 6-12 diagnosed with ADHD, 2007-2008. Principal Investigator: R. Bart Sangal, M.D. Supported by Shire.
  60. A phase IIIb, randomized, double-blind, multi-center, parallel-group, placebo-controlled, dose optimization study, designed to evaluate the efficacy and safety of methylphenidate transdermal system (MTS) in adolescents aged 13-17 years with attention-deficit/hyperactivity disorder (ADHD), 2007-2008. Principal Investigator: R. Bart Sangal, M.D. Supported by Shire.
  61. A Multicenter, randomized, double-blind, placebo-controlled, parallel study to investigate the efficacy and safety of VEC-162 (20 mg/day and 50 mg/day) in the treatment of primary insomnia, 2007-2008. Principal Investigator: R. Bart Sangal, M.D. Supported by Vanda.
  62. A Pilot, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 study of the safety, tolerability and efficacy of 0.7 mg/kg/day and 1.4 mg/kg/day ABT-089 in the treatment of children with Attention-Deficit/Hyperactivity Disorder (ADHD), 2008. Principal Investigator: R. Bart Sangal, M.D. Supported by Abbott.
  63. A Pilot, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 study of the safety, tolerability and efficacy of 40 mg qd and 80 mg qd ABT-089 in adults with Attention-Deficit/Hyperactivity Disorder (ADHD), 2008. Principal Investigator: R. Bart Sangal, M.D. Supported by Abbott.
  64. The long-term safety and tolerability of ABT-089 in children with Attention-Deficit/Hyperactivity Disorder (ADHD): an open-label extension study, 2008. Principal Investigator: R. Bart Sangal, M.D. Supported by Abbott.
  65. The long-term safety and tolerability of ABT-089 in children with Attention-Deficit/Hyperactivity Disorder (ADHD): an open-label extension study for subjects completing study M10-346, 2008. Principal Investigator: R. Bart Sangal, M.D. Supported by Abbott.
  66. A phase 2, randomized, double-blind, placebo- and active-comparator-controlled study of the safety and efficacy of LY2624803 in outpatients with insomnia, 2008 – 2010. Principal Investigator: R. Bart Sangal, M.D. Supported by Lilly.
  67. A phase III, randomized, double-blind, multi-center, parallel group, placebo-contolled, forced-dose titration, safety and efficacy study of lisdexamfetamine dimesylate (LDX) in adolescents aged 13-17 with attention-deficit/hyperactivity disorder (ADHD), 2008-2009. Principal Investigator: R. Bart Sangal, M.D. Supported by Shire.
  68. A phase III, open-label, extension, multi-center, safety and efficacy study of lisdexamfetamine dimesylate (LDX) in adolescents aged 13-17 with attention-deficit/hyperactivity disorder (ADHD), 2008 – now. Principal Investigator: R. Bart Sangal, M.D. Supported by Shire.
  69. Single Dose, open label safety, tolerability, pharmacokinetic and pharmacodynamic evaluation of three different eplivanserin doses in children aged 6-17 years with insomnia of various origins, 2009. Principal Investigator: R. Bart Sangal, M.D. Supported by Sanofi-Aventis.
  70. LY377604 + sibutramine hydrochloride monohydrate: a phase 2 weight loss efficacy study in overweight/obese men and women, 2009-2010. Principal Investigator: R. Bart Sangal, M.D. Supported by Lilly.
  71. A randomized, placebo-controlled, double-blind, fixed-dose study of the efficacy and safety of eszopiclone in children (6 to 11 years) and adolescents (12 to 17 years) with Attention-Deficit/Hyperactivity Disorder-associated Insomnia, 2009-2010. Principal Investigator: R. Bart Sangal, M.D. Supported by Sepracor.
  72. A long-term, open-label, safety study of eszopiclone in children (6 to 11 years) and adolescents (12-17 years) with Attention-Deficit/Hyperactivity Disorder associated Insomnia, 2009-2011. Principal Investigator: R. Bart Sangal, M.D. Supported by Sepracor.
  73. A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parralel Group study to evaluate the safety and efficacy of MK-4305 in patients with Primary Insomnia – Study B, 2010-2011. Principal Investigator: R. Bart Sangal, M.D. Supported by Merck.
  74. A Phase 3, Double-blind, Randomized, Multi-center, Placebo-controlled, Dose-optimization study evaluating the safety, efficacy, and tolerability of once-daily dosing with Extended-release Guanfacine Hydrochloride in adolescents aged 13-17 years diagnosed with Attention-deficit/Hyperactivity disorder (ADHD), 2012. Principal Investigator: R. Bart Sangal, M.D. Supported by Shire.
  75. A Phase 4, Randomized, Double-blind, Parallel-group, Active-controlled, Dose-optimization safety and efficacy study of SPD489 (VYVANSE) comapred with OROS-MPH (CONCERTA) with a Placebo reference arm, in adolescents aged 13-17 years with Attention-deficit/Hyperactivity disorder (ADHD), 2012. Principal Investigator: R. Bart Sangal, M.D. Supported by Shire.
  76. A Phase 4, Randomized, Double-blind, Multicenter, Parallel-group, Active-controlled, Forced-dose titration, safety and efficacy study of SPD489 (VYVANSE) compared with OROS-MPH (CONCERTA) with a Placebo reference arm in adolescents aged 13-17 yearw with Attention-deficit/Hyperactivity disorder (ADHD), 2012. Principal Investigator: R. Bart Sangal, M.D. Supported by Shire.
  77. Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Forced-dose Titration, Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years with Attention-deficit/Hyperactivity Disorder (ADHD), 2015-2016. Principal Investigator: R. Bart Sangal, M.D. Supported by Shire.
  78. A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy, 2015-2016. Principal Investigator: R. Bart Sangal, M.D. Supported by Jazz.
  79. A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Obstructive Sleep Apnea (OSA), 2015-2016. Principal Investigator: R. Bart Sangal, M.D. Supported by Jazz.
  80. A Long-Term, Open-Label Safety and Maintenance of Efficacy Study of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy or Obstructive Sleep Apnea, 2016-2017. Principal Investigator: R. Bart Sangal, M.D. Supported by Jazz.
  81. A Multicenter, Randomized, Double-blind, Placebo-controlled, Active comparator, Parallel-group study of the efficacy and safety of Lemborexant in subjects 55 and older with Insomnia Disorder. 2016-2017. Principal Investigator: R. Bart Sangal, M.D.Supported by Eisai.
  82. A 4-Week, Double-blind, Placebo-controlled, Randomized, Multicenter, Crossover Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate hydrochloride] in Subjects with Parkinson’s Disease and Excessive Sleepiness. 2017-2018. Principal Investigator: R. Bart Sangal, M.D. Supported by Jazz.
  83. A Randomized, Placebo-Controlled, Double-Blind, Crossover Study of Oral BTD-001 in Adults with Idiopathic Hypersomnia. 2018-2019. Principal Investigator: R. Bart Sangal, M.D. Supported by Balance Therapeutics.
  84. A Multicenter, Fixed-Dose, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of AR19 (Amphetamine Sulfacte) in Adult Subjects (Ages 18-55) with Attention Deficit Hyperactivity Disorder (ADHD). 2018. Principal Investigator: R. Bart Sangal, M.D. Supported by Arbor Pharmaceuticals.
  85. A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) with an Open-label Safety Extension. 2020. Principal Investigator: R. Bart Sangal, M.D. Supported by Jazz Pharmaceuticals.
  86. A Phase 2, Double-blind, Placebo-controlled, Parallel-group, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and efficany of 2 mg and 4 mg SUVN-G3031 compared to placebo in patients with narcolepsy with and without cataplexy. 2020-2023. Principal Investigator: R. Bart Sangal, M.D. Supported by Suven Life Sciences.
  87. A Four-week, Double-blind, Placebo-controlled, Randomized, Multicenter, Parallel-group Study of the Safety and Efficacy of NLS-2 (Mazindol extended release) in Adults for the Treatment of Narcolepsy. 2021-. Principal Investigator: R. Bart Sangal, M.D. Supported by NLS Pharmaceuticals.
  88. A 6-Month Multicenter, Open-Labelled Extension of the Clinical Trial NLS-1021 in Narcoleptic Patients with and without Cataplexy. 2021-. Principal Investigator: R. Bart Sangal, M.D. Supported by NLS Pharmaceuticals.
  89. Phase 2 Randomized Double-Blind Placebo-Controlled Parallel-Arm Dose Finding Study to Compare Fixed Dose Combinations of Atomoxetine/Aroxybutynin (AD109) to Atomoxetine alone or Placebo in Obstructive Sleep Apnea. 2021-. Principal Investigator: R. Bart Sangal, M.D. Supported by Apnimed.
  90. A Double-Blind, Placebo-controlled, randomized withdrawal study to evaluate the safety and efficacy of Pitolisant in adult patients with Idiopathic Hypersomnia. 2022-2023. Principal Investigator: R. Bart Sangal, M.D. Supported by Harmony Biosciences.
  91. An Open-Label Study to evaluate the long-term safety and effectiveness of Pitolisant in adult patients with Idiopathic Hypersomnia who completed study HBS-101-CL-010. 2022-. Principal Investigator: R. Bart Sangal, M.D. Supported by Harmony Biosciences.
  92. A Phase 2, Placebo-controlled, double-blind, randomized withdrawal study to determine the safety and efficacy of oral SDX in patients with Idiopathic Hypersomnia (IH). 2022-. Principal Investigator: R. Bart Sangal, M.D. Supported by Kem-Pharm.
  93. A Prospective, Open-Label, Single-Arm, Multicenter Study to Evaluate the Effect of Low-Sodium Oxybate Oral Solution (XYWAV) on Sleepiness, Polysomnography, and Functional Outcomes in Adult Participants Aged 18 to 75 Years With Idiopathic Hypersomnia or Narcolepsy. 2023-. Principal Investigator: R. Bart Sangal, M.D. Supported by Jazz.
  94. Phase 3 randomized double-blind placebo-controlled 1-year parallel-arm study to compare a fixed dose combination of aroxybutynin/atomoxetine (ad109) to placebo in obstructive sleep apnea, 2023-. Principal Investigator: R. Bart Sangal, M.D. Supported by Apnimed.

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