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Phase 3 study on schizoprenia

PHRR130306-000056

not mentioned

Unspecified

A Phase 3, Multicenter, Randomized, Double blind, Placebo controlled study of the efficacy and safety of ALKS 9072 in subjects with acute exacerbation of schizoprenia

This study involves patients with acute exacerbation of schizoprenia

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2012-12-20 12 2013-12-20 2013-09-25

Completed

Institution Classification Region LTO #
INC Research Pte. Ltd. Private Business NCR CDRR-NCR-CRO-1
Institution Amount Region
Alkermes, Inc. N/A United States of America
Name E-Mail Phone Number Postal Address
Phillip James Sayo phillipjames.sayo@incresearch.com 63 2 464 7010 Pasig City 1605
Name E-Mail Phone Number Postal Address
Darryl Ching darryl.ching@incresearch.com 63 2 4647001 Pasig City 1605
Name Expertise Affiliation
Efren Reyes, MD Psychiatry National Center for Mental Health
Cynthia Leynes, MD Psychiatry Philippine General Hospital
Lourdes Evangelista, MD Psychiatry Mariveles Mental Hospital
Fe Costales, MD Psychiatry Cebu Doctors North General Hospital
Josefina Ly-Uson, MD Psychiatry The Medical City
Georgina Gozo-Oliver, MD Psychiatry Veterans Memorial Medical Center
Elizabeth Rondain, MD Psychiatry Makati Medical Center
Rowena G. Cosca, MD Psychiatry Western Visayas Medical Center
Mariano Hembra, MD Psychiatry Iloilo Doctor's Hospital
Project Location Institutional Ethics Review Board
National Center for Mental Health National Center for Mental Health Institutional Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board
Mariveles Mental Hospital N/A
Cebu Doctors North General Hospital N/A
The Medical City The Medical City - Institutional Review Board
Veterans Memorial Medical Center Veterans Memorial Medical Center Ethics Review Committee
Makati Medical Center Makati Medical Center Institutional Review Board
Western Visayas Medical Center Western Visayas Medical Center
Iloilo Doctor's Hospital N/A

Schizoprenia

The primary efficacy endpoint is the PANSS total score change from baseline to Day 85. PANSS total score is defined as the sum of scores on the PANSS positive, negative, and general psychopathology subscale.

The secondary efficacy endpoint is the CGI-I scores at Day 85

Completed

  • Bulgaria
  • Malaysia
  • Philippines
  • Romania
  • Russia
  • Ukraine
  • United States

Clinical Trial

Unspecified

2012-12-20

None

INCLUSION CRITERIA: Diagnosis of schizophrenia according to DSM-IV-TR criteria Currently experiencing an acute exacerbation or relapse with onset of less than 2 months prior to screening If inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation ≥ 2 years have elapsed since initial onset of active-phase schizophrenia symptoms Has previously had a clinically significant beneficial response (improvement in schizophrenia symptoms), as determined by the investigator, to treatment with an antipsychotic medication other than clozapine Has been able to achieve outpatient status for more than 3 months in the past year PANSS that meets the following criteria at screening and baseline: Total score between 70 and 120, inclusive Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items: Item 1 (P1; delusions) Item 2 (P2; conceptual disorganization) Item 3 (P3; hallucinatory behavior) Item 6 (P6; suspiciousness/persecution) CGI-S score ≥ 4 at screening and baseline BMI of 18.5 to 40.0 kg/m2 (inclusive) EXCLUSION CRITERIA: History of poor or inadequate clinical response to treatment with aripiprazole History of treatment resistance, defined as failure to respond to 2 adequate trials of different antipsychotic medications (a minimum of 4 weeks at the subject's maximum tolerated dose) Known or suspected intolerance of, allergy, or hypersensitivity to aripiprazole, its excipients, other antipsychotic agent, or INTRALIPID® (including peanuts, soy, egg, or glycerol) History of neuroleptic malignant syndrome, clinically significant tardive dyskinesia, tardive dystonia, or other medical condition that would convey undue risk or interfere with study assessments. Clinically significant extrapyramidal symptoms at screening or baseline Answer “Yes” on items 4 or 5 of the C-SSRS (ideation) with the most recent episode occurring within the past 2 months, or answer “Yes” to any of the 5 items (behavior) with an episode occurring within the last year Diagnosis (according to DSM-IV-TR criteria) of substance (including alcohol) dependence currently or within 6 months before screening or abuse within 3 months before screening (exception: nicotine and caffeine are allowable) Comorbid neuropsychiatric disorders including; Life time diagnosis of schizoaffective disorder or bipolar disorder, or current, untreated or unstable major depressive disorder. clinically significant cognitive difficulties including dementia, delirium, or amnestic syndromes that have been present within the past 2 years and would interfere with participation in the study. Any other psychiatric condition that would, in the judgment of the investigator, interfere with participation in the study. Clinically significant or unstable medical illness/condition/disorder that would be anticipated, in the investigator’s opinion, to potentially compromise subject safety or adversely affect the evaluation of efficacy, including (but not necessarily limited to) the following: Clinically significant hypotension or hypertension not stabilized by medical therapy Unstable thyroid dysfunction in the past 6 months (eg, hypothyroidism, hyperthyroidism, or thyroiditis that was untreated, or discovered and treatment was initiated within the 6 months prior to screening) Insufficiently controlled diabetes mellitus in the judgment of the investigator Clinically significant renal insufficiency (also see exclusion criterion 9) Malignant tumor within the last 5 years (exception: dermal squamous or basal cell carcinoma or cervical carcinoma in situ allowable) Neurologic conditions including the following: History of seizure disorder or condition associated with seizures History of brain tumor, subdural hematoma or other clinically significant neurological condition within the past 12 months Head trauma with loss of consciousness within 12 months before screening Active acute or chronic central nervous system infection Stroke within 6 months before screening Cardiac conditions including the following: Clinically significant cardiac arrhythmia, cardiomyopathy, or cardiac conduction defect, history of myocardial infarction or unstable angina within the last 3 months before screening, or clinically significant abnormality on screening or baseline electrocardiogram (ECG) including but not limited to the following: −QTcF >465 msec if male or >485 msec if female - Laboratory abnormality that, in the opinion of the investigator (after consultation with the INC Research medical monitor if necessary, would compromise the well-being of the subject), or any of the following laboratory abnormalities at screening or baseline: -Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value ≥2 times the upper limit of the laboratory normal reference range -Hemoglobin A1c (HbA1c) >9% -Absolute neutrophil count ≤ 1.5 × 103 μL -Platelet count ≤ 75 × 103 μL -Serum creatinine > 2.5 mg/dL -Positive test result for human immunodeficiency virus, hepatitis B surface antigen, or anti-hepatitis C virus antibody -Positive pregnancy test result -Urine drug screen at screening or baseline shows a positive result for any of the tested substances (see Section 7.4.9.5) Exception: results positive for benzodiazepine or opiates may not be exclusionary if the investigator confirms that such medication was medically indicated and consults the INC Research medical monitor before enrolling a subject with such a finding. -Pregnant, lactating, or breastfeeding

Interventional

ALKS 9072

ALKS 9072 is formulated as a sterile aqueous suspension for injection that contains 180-mg free-base equivalents of aripiprazole active moiety per mL of suspension solution. The suspension vehicle contains the following: sorbitan laurate, polysorbate 20, phosphate buffer, sodium chloride, and water for injection. ALKS 9072 is N-lauryloxymethyl aripiprazole, which is a prodrug compound in which the lactam nitrogen of aripiprazole has been reversibly functionalized. ALKS 9072 is highly hydrophobic and practically insoluble in water

Randomized

Double Blind

Unspecified

Parallel

To determine the efficacy of ALKS 9072 for the treatment of schizophrenia in subjects experiencing an acute exacerbation

Phase III

40

47

Over recruitment by sites

20 Dec 2012

Utilization Utilization Info
No records found.

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