Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 9.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Conditions
Interventions
Product Name: ONO-2506PO
Product Code: ONO-2506PO
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Arundic Acid
CAS Number: 185517-21-9
Current Sponsor code: ONO-2506PO
Other descriptive name:
Sponsors
ONO Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult males and females patients with diagnosis of ALS over the age of 18 years. 2. Previous randomisation and completion of the last visits (Visit 11: Month 18) in ONO- 2506POE014 study. 3. Ability to swallow study medication without the requirement for nasogastric or percutaneous endoscopic gastrostomy (PEG) feeding as evidenced by a score of = 3 on ALSFRS-R question # c (swallowing) at Visit 1 (same as Visit 11 in study ONO- 2506POE014). 4. Agreement for themselves or their partner to use an adequate method of contraception throughout the study. Adequate methods of contraception for themselves or their partner include but are not limited to barrier method (i.e. condoms, diaphragm with spermicide gel), surgical sterilisation, vasectomy and abstinence. 5. Concomitant standard Riluzole therapy (50mg twice daily) during study ONO- 2506POE014. 6. Patients whom the investigator has no concern and judges tolerable for the continue treatment with ONO-2506PO and Riluzole from a risk and benefit point of view. 7. Able and willing to give written informed consent, personally or via their legally authorised representative. 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: 1. Requirement for prescription drugs that are metabolised via the cytochrome P450 2C9 listed in section 9.5.3. 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 patient. 3. Presence or intention of pregnancy and breast feeding (female patients only). 4. Males with the intention of fathering a child during the study period. 5. Observed drug or alcohol abuse during study ONO-2506POE014 (alcoholic patients who are recovered for at least 2 years will be allowed to enrol in the study). 6. Patients who have used any other investigational drug and/or participated in any clinical trial since their participation in study ONO-2506POE014.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study will be to evaluate the long term safety of ALS patients following dosing of ONO-2506PO, 1200mg OD. The following safety information will be collected during the study. • Adverse events • Death • Tracheotomy or permanent assisted ventilation;Secondary Objective: There is no secondary objective;Primary end point(s): There is no primary ‘efficacy’ endpoint. Primary endpoint is safety (evaluated using AEs, death rates, occurrence of tracheotomy/PAV). | — |
Countries
Belgium, France, Germany, United Kingdom
Outcome results
None listed