A MULTI-CENTRE, RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO, IN THE PRESENCE OF RILUZOLE, TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS ALS , WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION - ND
- Conditions
- Amyotrophic Lateral SclerosisMedDRA version: 8.1Level: LLTClassification code 10002026Term: Amyotrophic lateral sclerosis
- Registration Number
- EUCTR2006-002660-26-IT
- Lead Sponsor
- ONO PHARMA UK LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 392
1. Adult males and females aged 18 to 75 years 2. Diagnosis of clinically possible, clinically probable laboratory-supported, clinically probable, or clinically definite ALS according to WNF EL Escorial diagnostic criteria, revised according to the Airlie House Conference 1998 3. Onset of muscle weakness within 14 months of randomisation 4. Baseline SVC greater than or equal to 70 of predicted normal at Visit 1 screening visit See section 11.2.1.1 for details 5. Concomitant standard Riluzole therapy 50mg twice daily for at least 2 weeks prior to Visit 1 screening visit , with liver function test LFT results within two times the upper limit of the normal range 6. Ability to swallow without the requirement for nasogastric or percutaneous endoscopic gastrostomy PEG feeding as evidenced by a score of 8805; 3 on ALSFRS-R question c swallowing at Visit 1 screening visit 7. Agreement for themselves or their partner to use an adequate method of contraception throughout the study and for 2 weeks after post study visit. 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 8. Able and willing to give written informed consent, personally or via their legally authorised representative See 7.2.2.
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
1. Presence of a tracheotomy, mechanical ventilation or non-invasive ventilation as evidenced by a score of 8804; 3 on ALSFRS-R question i respiratory insufficiency at Visit 1 screening visit 2. Requirement for prescription drugs used for potential neuroprotective benefit listed in section 10.5.3.1, for one month prior to Visit 1 screening visit 3. Requirement for prescription drugs that are metabolised via the cytochrome P450 2C9 listed in section 10.5.3.2, for one week prior to Visit 1 screening visit 4. A clinically relevant medical history or presence of respiratory diseases or disorders such as moderate-to-severe asthma and chronic obstructive pulmonary disease that, in the opinion of the Investigator, may pose an unwarranted risk to the subject or confound the results of the study 5. A history or presence of malignancy within the past 3 years 6. A history or presence of other life threatening diseases within the past 3 years 7. 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 or confound the results of the study 8. Presence or intention of pregnancy and breast feeding female subjects only 9. Males with the intention of fathering a child during the study period 10. A history of drug or alcohol abuse alcoholic subjects who are recovered for at least 2 years will be allowed to enrol in the study 11. Subjects who have used any investigational drug and /or participated in any clinical trial within 3 months of entry to this study 12. Subjects who have previously received ONO-2506PO
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method