Value through Innovation27 July 2016

Clinical Study Results

  • Olcegepant - Healthy
    Clinical Study Number 1149.1
    Study Indication Healthy
    Product Olcegepant
    Generic Name Olcegepant
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind, placebo-controlled single rising dose tolerability study (parallel groups) in healthy male and female volunteers after intravenous administration of BIBN 4096 BS (dosage: 0.1 - 10 mg)

    Study Document Trial synopsis 1149.1 english
  • Olcegepant - Migraine Disorders
    Clinical Study Number 1149.2
    Study Indication Migraine Disorders
    Product Olcegepant
    Generic Name Olcegepant
    Lab Code
    Clinical Phase IIa
    Study Title

    A Phase IIa, double Blind, Ransomised, Group Sequential Adaptive Assignment Desing Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of seven Fixed Doses of Intravenous BIBN 4096 BS ranging from 0.1 to 10.0 mg Versus Placebo in the Treatment of a Single Attack of Acute Migraine Headache.

    Study Document Trial synopsis 1149.2_CO english
  • Olcegepant - Healthy
    Clinical Study Number 1149.3
    Study Indication Healthy
    Product Olcegepant
    Generic Name Olcegepant
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind (within dose groups), placebo-controlled single rising dose tolerability study (parallel groups) in healthy male and female volunteers after intranasal administration of BIBN 4096 BS (dosage: 2.5 - 20 mg)

    Study Document Trial synopsis 1149.3 english
  • Olcegepant - Healthy
    Clinical Study Number 1149.31
    Study Indication Healthy
    Product Olcegepant
    Generic Name Olcegepant
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind (within dose groups), randomized, placebo-controlled single increasing dose tolerability study (parallel groups) in healthy male and female volunteers after subcutaneous administration of BIBN 4096 BS (dosage: 2.5 - 30 mg)

    Study Document Trial synopsis 1149.31_CO english
  • Olcegepant - Healthy
    Clinical Study Number 1149.34
    Study Indication Healthy
    Product Olcegepant
    Generic Name Olcegepant
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind (within dose groups), randomised, placebo-controlled single increasing dose safety, tolerability and pharmacokinetics study (parallel groups) in healthy male and female volunteers after oral administration of BIBN 4096 BS drinking solution (dosage: 20 - 200 mg)

    Study Document Trial synopsis 1149.34 english
  • Olcegepant - Healthy
    Clinical Study Number 1149.35
    Study Indication Healthy
    Product Olcegepant
    Generic Name Olcegepant
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind (at each dose level), randomised, placebo-controlled single increasing dose safety, tolerability and pharmacokinetics study in healthy male and female volunteers after intranasal administration of BIBN 4096 BS (dosage: 6.25 - 200 mg)

    Study Document Trial synopsis 1149.35 english
  • Olcegepant - Healthy
    Clinical Study Number 1149.37
    Study Indication Healthy
    Product Olcegepant
    Generic Name Olcegepant
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind (at each dose level), randomised, placebo-controlled single increasing dose safety, tolerability and pharmacokinetics study in healthy male and female volunteers after inhalative administration of BIBN 4096 BS (dosage: 5 - 80 mg)

    Study Document Trial synopsis 1149.37 english
  • Olcegepant - Healthy
    Clinical Study Number 1149.44
    Study Indication Healthy
    Product Olcegepant
    Generic Name Olcegepant
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind (at each dose level), randomised, placebo-controlled, single rising dose study investigating the safety, tolerability and pharmacokinetics of spray dried BIBN 4096 BS after inhalation administration in healthy male and female volunteers (dosage: 4.75 - 40 mg metered dose / 2 - 16 mg fine particle dose)

    Study Document Trial synopsis 1149.44_CO english

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