E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cognitive Deficits in Schizophrenia |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039626 |
E.1.2 | Term | Schizophrenia |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluate the efficacy and safety of ABT-126 in the treatment of cognitive deficits in schizophrenia (CDS). |
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E.2.2 | Secondary objectives of the trial |
Dose finding and pilot HEOR assessments
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female between 20 and 65 years of age, inclusive, at the time of randomization.
2. Has a current DSM-IV-TR diagnosis of schizophrenia confirmed by the M.I.N.I.
3. Is receiving one or two antipsychotic medications, restricted to any of the following allowable agents: amisulpride, aripiprazole, asenapine, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone, haloperidol, fluphenazine, perphenazine, flupenthixol, melperone, penfluridol, thiothixene, trifluoperazine, and zotepine. Antipsychotics that are unlisted by the protocol (either as allowed or excluded as in Section 5.2.3 of the protocol) may be allowed if approval is obtained from the AbbVie medical monitor prior to randomization.
4. Is clinically stable in the residual phase of the illness, as defined by the following criteria:
• Level of Care: The subject has had no psychiatric inpatient hospitalization, no overnight crisis stabilization, no emergency room visit for psychiatric symptoms, and no other overt signs of destabilization in the 4 months prior to Screening Visit 1.
• Stability of Medication Regimen: The subject has had no symptom-related changes in antipsychotic, antidepressant, or mood-stabilizing medications within 8 weeks prior to Day –1 and no changes in dose(s) of those medications for any reason within 4 weeks prior to Day –1.
• Severity of Symptoms: Core positive symptoms are no worse than moderate in severity, extrapyramidal symptoms (EPS) are no worse than mild in severity, and depressive symptoms are not consistent with a major depressive episode from the start of Screening through the end of the Prospective Stabilization Period, as defined by the following:
o Positive and Negative Syndrome Scale (PANSS) item scores of ≤ 5 each for delusions (P1), conceptual disorganization (P2), hallucinatory behavior (P3), and excitement (P4);
o In the Investigator's judgment, no clinically significant EPS at Screening Visit 1, a Severity of Abnormal Movements item score of ≤ 2 on the Abnormal Involuntary Movement Scale (AIMS) at Day –1, and a Global Clinical Rating of Akathisia score of ≤ 2 on the Barnes Akathisia Rating Scale (BAS) at Day –1;
o Calgary Depression Scale for Schizophrenia (CDSS) total score of ≤ 10 at Screening Visit 1.
5. Has been diagnosed with or treated for schizophrenia for at least 2 years prior to Screening Visit 1. A subject who is hospitalized for social reasons but is otherwise symptomatically stable is acceptable.
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E.4 | Principal exclusion criteria |
1. In the Investigator's judgment, has a current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, post traumatic stress disorder, or obsessive-compulsive disorder, or the subject has a current major depressive episode.
2. Has a positive urine drug screen for cocaine, phencyclidine (PCP), opiates (unless duly prescribed), benzodiazepines (unless duly prescribed), marijuana, or amphetamines at Screening Visit 1, Screening Visit 2 or Day –1.
3. Has either a body mass index (BMI) > 45 kg/m2 or a body weight >145 kg at Screening Visit 1. BMI is calculated as weight in kilograms divided by the square of height in meters (kg/m2).
4. Has a current or past history of seizures, with the exception of a single febrile seizure occurring prior to 6 years of age.
5. Has a clinically significant abnormal ECG at Screening Visit 1 as determined by the Investigator.
6. Has any risk factors for Torsades de Pointes (TdP) |
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E.5 End points |
E.5.1 | Primary end point(s) |
MATRICS Consensus Cognitive Battery (MCCB) change from baseline |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
UCSD Performance-Based Skills Assessment (UPSA) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Romania |
Russian Federation |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End-of-study is defined as the date of last subject's last visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |