E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Amyotrophic lateral sclerosis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LL 1 |
E.1.2 | Classification code | 10002026 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study will be to evaluate the long-term safety of ONO-2506PO following dosing (1200 mg OD) to subjects with amyotrophic lateral sclerosis. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this study will be to evaluate survival times following dosing of ONO-2506PO (1200 mg OD) to subjects with amyotrophic lateral sclerosis. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
•Adult males and females aged over 18years. •Previous randomisation in clinical study ONO-2506PO/EU0106. •Completion of all visits in clinical study ONO-2506PO/EU0106. •Ability to swallow ONO-2506PO capsules. •Ability to comply with the dosing regimen and visit schedule. •Agreement for themselves or their partner to use an adequate method of contraception throughout the study and for 2 weeks post-study. Adequate methods of contraception for themselves or their partner include condoms, diaphragm with spermicidal gel, coil (intra-uterine device), surgical sterilisation, vasectomy and abstinence. •Able and willing to give written informed consent.
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E.4 | Principal exclusion criteria |
•Requirement for any medications metabolised via the cytochrome P450 2C9 pathway and may compromise subject safety due to elevated plasma levels, or those listed in section 7.6.2. •A clinically relevant medical history or presence of cardiovascular, gastrointestinal, renal, hepatic, endocrine/metabolic, neurologic, lymphatic, haematologic, immunologic, musculoskeletal, connective tissue, dermatologic, genito/urinary, psychiatric diseases or disorders that, in the opinion of the Investigator, may pose an unwarranted risk to the subject. •Previous participation in any ONO-2506 study, with the exception of ONO-2506PO/EU0106. •Previous participation in any other study since their participation in study ONO-2506PO/EU0106. •Presence or intention of pregnancy and breast-feeding (female subjects only). •Males with the intention of fathering a child during the study period.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of this study is to evaluate the long-term safety of ONO-2506PO following dosing (1200 mg OD) to ALS subjects. The following safety parameters will be considered of primary importance: adverse events, withdrawals, deaths, laboratory parameters and weight. All tables and listings will be based on the Safety Population. Additional summaries of safety parameters based on subsets of the population (e.g. subjects initially randomised to ONO-2506PO (1200 mg OD) and placebo in study ONO-2506PO/EU0106) will be specified in the statistical analysis plan.
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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 | Information not present in EudraCT |
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 | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | No |
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
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |