Phase I and IIa Study Metrics

Phase I Healthy and Special Patient Populations Study Metrics

Alliance Phase I Units have met 100% of their Phase I study enrollment goals and timelines as a single site

  • Addiction DDI RESCUE: A Phase I, Open-Label, Drug-Drug Interaction Study Between Methadone and xxx, and Between Buprenorphine/Naloxone and xxx
    2016: Enrolled and completed 8 in 6 weeks as a rescue site
  • Healthy Adult SAD qEEG: A Double-Blind, Placebo-Controlled, Randomized, 2 Stage, 2 Way Crossover Study of a Single Oral Dose of xxx in Healthy Adult Subjects (included electrophysiology measures)
    2016: Enrolled 2 cohorts of 24 (48) in 2 months
  • Healthy Smokers MRD RESCUE: Phase I combined single and multiple rising dose study of the safety and pharmacokinetics of xxx combination (xxx)
    2015: Enrolled 1 cohort of 5 as a RESCUE site and 2 cohorts of 8 (21 subjects) in 2 months
  • Hepatic Impairment PK: Systemic Pharmacokinetics of Intranasal xxx in Hepatic-impaired Individuals
    2016: Enrolled and completed 24 in 5 months
  • Japanese Bridging SAD/MAD RESCUE: A Rising Single and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of xxx in Healthy Adult Japanese Subjects (1st and 2nd generation)
    2016: Enrolled and completed 2 cohorts of 8 (16) in < 2 months over the holidays
  • Major Depression: A Phase I Effect of xxx on Ambulatory Heart Rate and Blood Pressure in patients with Major Depressive Disorder who are being Treated with Selective Serotonin Reuptake Inhibitors
    2011: Enrolled and completed 12 in 6 weeks
  • Migraine PK: A Phase I, Open-Label, Randomized, Parallel Group, Crossover Study to Compare the Pharmacokinetcs of xxx in Migraine Subjects During an Acute Migraine Attack and During a Non-Migraine Period
    2012: Enrolled and completed 20 in 8 months – Top Enrolling Site
  • Parkinson’s: A Phase I Randomized, Double-blind, Placebo-controlled, Ascending Dose Study of Safety and Tolerability of xxx in Adult Patients With Parkinson’s Disease Who Are Receiving xxx
    2010: Enrolled and completed 15 in 1 month
  • Schizophrenia Bioequivalence PK: A Phase I,  Open-Label, Randomized, Multiple Dose, Safety and Pharmacokinetic Trial with Injectable Risperidone-SABER® Compared to Risperdal® Consta® in Patients with Chronic, Stable Schizophrenia or Schizoaffective Disorder
    2015: Enrolled and completed 4 cohorts of 10 (40) in 3 months
  • Schizophrenia MAD: A Phase I; Randomized; Single Blind; Placebo Controlled; Ascending Multiple Oral Dose Study Assessing the Safety, Tolerability, and Pharmacokinetics of xxx in Male and Female Subjects with Schizophrenia
    2014: Enrolled and completed 64 in 11 months
  • Schizophrenia MAD qEEG: A Phase I; Double-Blind; Randomized; Multiple Ascending Dose Safety, Tolerability, and Pharmacokinetics Study in Patients with Schizophrenia on a Stable Anti-Psychotic regimen (other than clozapine)
    2015: Enrolled and completed 4 cohorts of 10 (40) in 4 months
  • Schizophrenia SAD RESCUE: A Phase I; Randomized; Single-Blind; Placebo-Controlled; Ascending Single Oral Dose Study Assessing the Safety, Tolerability, and Pharmacokinetics of xxx in Male and Female Subjects with Schizophrenia
    2014: Enrolled and completed 36 in 3 months
  • Severe Renal Impairment PK: A Phase I Study Comparing the Pharmacokinetics of Intranasal xxx in Subjects with Severe Renal Impairment and Subjects with Normal Renal Function
    2016: Enrolled and completed 16 in 4 months

Multi-site Phase I Study Metrics

  • Healthy Adults and Healthy Elderly Digital Software Study: Reliability and validity of an online neurocognitive test battery, the XXX Test, in normal healthy adults
    2016: Screened and enrolled 227 in 5 months, across 3 Alliance sites
  • Healthy Elderly (3 CSF samplings): A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of 3 month Multiple Oral Doses of xxx on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Elderly Subjects
    2016: Screened 37 and enrolled 15 in 3 months
  • Healthy Sleep: A Multicenter, Open-Label Study to Determine the Effects of xxx on Sleep in Healthy Subjects
    2012: screened 26 and enrolled 13over 5 months  – Top Enrolling Site
  • Major Depression: A Phase I, Randomized, Double-Blind, Placebo-Controlled Study of Safety and Pharmacodynamic Effects of xxx in Major Depressive Disorder Subjects
    2011: Screened 38 and enrolled 22 in 6 weeks (across 2 Alliance sites)
  • Parkinson’s MAD: A Phase I, Open-Label, Single Group, Multiple-Dose, Study to Evaluate the Pharmacokinetics of xxx Patch following 24-hr Application in Patients Diagnosed with Parkinson’s Disease
    2012: Screened 18 and enrolled 12 in 4 months
  • Schizophrenia MAD: A Phase I; Multicenter; Randomized; Double-blind; Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending, Multiple Oral Doses of xxx in Clinically Stable Adults with Schizophrenia
    2012: Screened 30 and enrolled 16 in 6 weeks
  • Schizophrenia MAD QTc: A Phase I, Parallel-group, Double-blind, Placebo and Positive Controlled Multiple Oral Dose Administration Trial to Evaluate the Effects of xxx on QT/QTc in Subjects with Schizophrenia or Schizoaffective Disorder
    2012: Screened 34 and enrolled 25 in 2 weeks
  • Schizophrenia PK: A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of xxx Following Administration to the Deltoid or Gluteal Muscle in Adults with Schizophrenia or Schizoaffective Disorder
    2016: Screened 13 and enrolled 10 in 2 weeks

Phase IIa Special Patient Populations Study Metrics

  • Adult ADHD: 49 screened, 24 randomized over 5 months
  • Alzheimer’s: 8 screened, 5 randomized over 9 months
  • Adult ADHD: 17 screened, 14 randomized in 3 months
  • Episodic Migraine: 23 screened, 15 randomized over 6 weeks
  • Parkinson’s: 11 screened, 10 randomized over 1 month
  • Schizophrenia inpatient: 134 screened, 98 randomized over 7 months
  • Schizophrenia: 57 screened, 41 randomized over 5 months
  • Schizophrenia QTc: 18 screened, 15 randomized over 1 month (across two sites)