| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Lu 31-130 is under development by H. Lundbeck A/S as an antipsychotic in the treatment of schizophrenia |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10039639 |
| E.1.2 | Term | Schizophrenia, paranoid type |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10039637 |
| E.1.2 | Term | Schizophrenia, catatonic type |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10039638 |
| E.1.2 | Term | Schizophrenia, disorganised type |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10052792 |
| E.1.2 | Term | Schizophrenia, undifferentiated type |
|
| 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 |
to explore efficacy of Lu 31-130 (5 or 7mg/day) compared to olanzapine (10 or 15mg/day) following 12 weeks of treatment by means of change in PANSS total score in patients with schizophrenia
to explore effect of Lu 31-130 (5 or 7mg/day) on neurocognitive performance compared to olanzapine (10 or 15mg/day) using the Brief Assessment of Cognition in Schizophrenia battery
to explore effect of Lu 31-130 (5 or 7mg/day) on depressive symptoms compared to olanzapine (10 or 15 mg/day) using Calgary Depression Scale for Schizophrenia
to explore effect of Lu 31-130 (5 or 7mg/day) on body weight compared to olanzapine (10 or 15mg/day)
to explore effect of Lu 31-130 (5 or 7mg/day) on body mass index, waist circumference, total cholesterol, LDL-cholesterol, VLDL-cholesterol, HDL-cholesterol, triglycerides, HbA1c and fasting glucose compared to olanzapine (10 or 15mg/day)
to explore effect of Lu 31-130 (5 or 7mg/day) on serum levels of ALAT and ASAT compared to olanzapine (10 or 15mg/day) |
|
| E.2.2 | Secondary objectives of the trial |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. The patient and/or legally acceptable representative and/or impartial witness (if wished for by the patient) is/are able to read and understand the Patient Information Sheet
2. The patient and/or legally accepted representative and/or impartial witness (if wished for by the patient) has/have read the Patient Information Sheet
3. The patient and/or legally accepted representative has/have signed the Informed Consent Form and impartial witness (if wished for by the patient) has co-signed the Informed Consent Form (if relevant) and this was done prior to the conduct of any study related procedures
4. The patient has a primary diagnosis of schizophrenia according to DSM-IV TR (codes 295.10, 295.20, 295.30, 295.90)
5. The patient is a man or woman, aged between 18 and 65 years (extremes included)
6. The patient is able to communicate with study personnel
7. The patient has a PANSS total score between 70 and 120 (extremes included) at Screening 2 and Baseline
8. The patient has a CGI-S score equal or more than 4 (moderately ill) at Screening 1, Screening 2 and Baseline
9. The patient is willing to be hospitalised during the period from Screening 2 until vist 5 at least
10. The patient, if a woman, must:
- agree not to try to become pregnant during the study, AND
- use adequate contraception (adequate contraception is defined as oral/systemic contraception, intrauterine device, diaphragm in combination with spermicide, or condom for male partner in combination with spermicide), OR
- have been surgically sterilised prior to Baseline, OR
- have had a hysterectomy prior to Baseline, OR
- not have been sexually active |
|
| E.4 | Principal exclusion criteria |
1 The patient has a current Axis I primary psychiatric diagnosis other than schizophrenia except for nicotine- or caffeine-related disorder (DSM-IV TR criteria)
2 The patient is at significant risk of suicide
3 The patient has shown violent behaviour within 12 months prior to Screening1
4 The patient is treatment-resistent to antipsychotic treatment
5 The patient has been treated with clozapine within 60 days prior to Screening1
6 The patient has other psychiatric, neurological (including tardive dyskinesia), or behavioural disorders that may interfere with the study results
7 The patient has a history of alcohol- or substance-related disorder (except nicotine, caffeine) based on DSM-IV-TR criteria within six months prior to Screening 1
8 The patient has a positive drug screen at Screening1, with the exception that positive result for opioids, cannabinoids, and benzodiazepines will be evaluated by Investigator on the impact for study participation
9 The patient has abnormal (above the upper limit of normal range) liver biochemistry
values (that is, ASAT, ALAT, AP, and total bilirubin) based on the blood samples drawn at Screening1.
10 The patient has positive serology for Hepatitis A (anti HAV IgM), Hepatitis B (HbsAg), Hepatitis C (HCV), or HIV based on blood samples drawn at Screening 1
11 The patient has a present condition that might compromise the liver function (for example alcohol abuse, hepatitis, hepatic insufficiency, cholestasis, haemochromatosis, deficit in alpha 1 antitrypsine, Wilson Disease, autoimmune diseases, cirrhosis)
12 The patient has one or more laboratory values outside the normal reference range, that are considered by investigator to be clinically significant
13 The patient is diagnosed with diabetes mellitus
14 The patient has a history of moderate or severe head trauma or other neurological disorders and systemic medical diseases, which are likely to affect the central nervous system functioning
15 The patient has a history of neuroleptic malignant syndrome
16 The patient has an uncorrected hypothyroridism or hyperthyroidism
17 The patient has a history of severe drug allergy or hypersensitivity, to or has other contraindications to serotonergic agents, dopamine antagonists, or dopamine agonists
18 The patient uses disallowed medication, or it is expected that the patient will require treatment with at least one of the disallowed concomittant medications during the study
19 The patient has a clinically significant unstable illness
20 The patient has a malignant disease or a history of malignant disease, other than adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin, within the past five years prior to Screening1
21 The patient has clinically significant abnormal vital signs
22 The patient has uncontrolled or symptomatic hypotension, or orthostatic hypotension
23 The patient has a history of repeated vasovagal syncope
24 The patient has an abnormal ECG recorded at Screening1 that is considered to be clinically significant
25 The patient has a QTc interval on the ECG recorded at Screening1 above 450 msec when using the Fridericia correction or a family history of Long QT Syndrome or a history of hypokalaemia or has known heart failure (NYHA II-IV) or if the patient takes medication that prolongs the QTc interval
26 The patient has a known ischaemic heart disease or a history of myocardial infarction (within the previous 12 months), coronary artery bypass surgery or percutaneous transluminal coronary angioplasty
27 The patient has narrow angle glaucoma
28 The patient has a disease or takes medication that, in the opinion of investigator, could interfere with the assessments of safety, tolerability, or efficacy
29 The patient has received a depot antipsychotic medication less than one dose interval prior to Screening1
30 The patient has received electro-convulsive therapy (ECT) within 12 weeks prior to Screening1
31 The patient has been treated with any investigational medicinal product within 30 days or 5 times the half-life of the IMP, whichever is longest, prior to Screening1
32 The patient has previously been exposed to Lu 31-130
33 The patient has been treated with an adequate course of olanzapine and failed to respond or has intolerance to the drug
34 The patient has been treated with olanzapine within 6 months prior to Screening1
35 The patient is pregnant or breats-feeding
36 The patient, in the opinion of investigator, is unsuitable for any reason. This includes patients who are unable to give informed consent, indicated by a score more or equal to 5 (moderate-to-severe) at any of the following PANSS items at Screening 2 and Baseline:
P7 hostility
G8 uncooperativeness
37 The patient is a member of the site personnel or immediate families
38 The patient is under forced treatment and/or involuntary hospitalisation |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
|
| 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 | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | Yes |
| E.6.11 | Pharmacogenomic | Yes |
| 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 | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| 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 | 3 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 13 |
| 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 | Information not present in EudraCT |
| 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 |
|
| 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
|
The end of the study is defined as the last protocol-specified contat with a patient. This could be a telephone contact 30 days after last study drug intake or a follow up visit.
After withdrawal from the study or completion of the study, the patient should be treated according to normal clinical practice starting from the day after the last dose of IMP. |
|
| 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 | 5 |
| 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 | 5 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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