Open-Label Extension Study to Investigate the Continued Safety and Effect of ONO 2506PO (1200 mg OD).

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002912-27-ES

Enrollment

500

Registered

2005-04-27

Start date

2004-10-04

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic lateral sclerosis MedDRA version: 7.0 Level: LL 1 Classification code 10002026

Interventions

Product Name: ONO-2506PO Product Code: ONO-2506PO Pharmaceutical Form: Capsule, soft INN or Proposed INN: (R)-(-)-2-Propyloctaroic acid Current Sponsor code: ONO-2506PO Concentration unit: mg milligra

Eligibility

Sex/Gender

All

Inclusion criteria

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: 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.;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.	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: 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.;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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Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026