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

Phase 1

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

• Registration Number: EUCTR2004-002912-27-ES
• Lead Sponsor: ONO PHARMA UK LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2005-03-16
• Study Start: 2005-04-27
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified