Recent Updates
Recently added Catalysts

Intramuscular Olanzapine Depot

Phase 3

Schizophrenic Disorders | Small molecule | Other |Eli Lilly and Company|Last Updated: Jan 11, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment2,136
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00088465Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective DisorderPHASE3 COMPLETED 931Aug 1, 2004Dec 1, 2010Jan 11, 201292 United States, Argentina +23
NCT00088491Comparison of Intramuscular Olanzapine Depot to Oral Olanzapine and Low-Dose Depot in Patients With SchizophreniaPHASE3 COMPLETED 1,205Jun 1, 2004Oct 1, 2006Jun 22, 20074 Finland, Turkey (Türkiye)
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of Participants With Adverse Events (AE)
Randomization to end of study up to 76 months

The list of serious adverse events (SAE) and other non-serious adverse events (AE) are in Adverse Events Section.

Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline
Randomization to end of study up to 76 months

Prolactin normal reference ranges for female: 2.0 - 29.0 nanograms per milliliter (ng/mL); male: 2.0 - 20.0 ng/mL. High value is defined as a change from a value less than or equal to the high limit at all baseline visits to a value greater than the high limit at any time after baseline.

Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline
Randomization to end of study up to 76 months

High ALT is defined as a baseline value of \<3 times the upper limit of normal (ULN) to ≥3 times the ULN at any time post baseline. High AST is defined as a baseline value of \<5 times the ULN to ≥5 times the ULN at any time post baseline. High total bilirubin is defined as a baseline value of \<2 times the ULN to ≥2 times the ULN at any time post baseline.

Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline
Randomization to end of study up to 76 months

Normal to high fasting glucose ≤100 milligrams per deciliter (mg/dL) at baseline to ≥126 mg/dL any time post baseline.

Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline
Randomization to end of study up to 76 months

Normal to high fasting total cholesterol ≤200 mg/dL at baseline to ≥240 mg/dL any time post baseline. Fasting triglycerides \<150 mg/dL at baseline to ≥200 mg/dL and \<500 mg/dL any time post baseline.

Change From Baseline in Weight at Month 76 Endpoint
Baseline, up to 76 months

Mean change in weight from baseline to last observation carried forward (LOCF) endpoint.

Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint
Randomization to end of study up to 76 months

PCS weight gain is defined as a ≥7% increase in weight from baseline.

Number of Participants With Extrapyramidal Symptoms at Any Time
Randomization to end of study up to 76 months

Extrapyramidal symptoms are defined as Simpson-Angus total score (SAS) \>3 at any post-baseline visit; Barnes Akathisia Scale (BAS) global score ≥2 at any post-baseline visit; A score ≥3 for any of Abnormal Involuntary Movement Scale (AIMS) for items 1-7 or a score ≥2 for any two of these items. Score for SAS is 0-4 for each of the 10 questions, with 0=normal and 4=extreme. The possible total score for SAS is 0-40. Possible score for BAS is 0-5, with 0=absent and 5=sever. Score 0-4 for each item of AIMS, with 0 =none and 4= sever. Possible total score for items 1-7 is 0-28.

Determine comparative efficacy in patients with schizophrenia of non-inferiority of IM olanzapine depot high and low doses versus oral olanzapine based on exacerbation rates after 6 months of maintenance treatment
Determine comparative efficacy in patients with schizophrenia of superiority of IM olanzapine depot low, med and high doses versus very low dose based on time to exacerbation of symptoms of schizophrenia
Secondary Endpoints
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint
Baseline, up to 76 months
Change From Baseline in PANSS Positive Scores at Month 76 Endpoint
Baseline, up to 76 months
Change From Baseline in PANSS Negative Scores at Month 76 Endpoint
Baseline, up to 76 months
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Intramuscular Olanzapine DepotEXPERIMENTALIntramuscular (IM) olanzapine depot flexible dosing and flexible interval
Interventions
NameTypeDescription
Intramuscular olanzapine depotDRUG45-405 milligram (mg), intramuscular injection, on a 2-, 3-, or 4-week interval.
Oral OlanzapineDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 76 Years
SexALL
Healthy VolunteersNo
Study Sites92

Inclusion Criteria: * Patients must have schizophrenia * Female patients of childbearing potential must be using a medically accepted means of contraception * Patients must have completed (within 10 days) another IM olanzapine depot study if permitted by that study's protocol. Exclusion Criteria: ...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilCroatiaCzechiaFranceGermanyHungaryIsraelItalyMexicoNetherlandsPolandPortugalPuerto RicoRomaniaRussiaSlovakiaSouth AfricaSpainSwedenTaiwanFinlandTurkey (Türkiye)
Unlock Eligibility Criteria