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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-002660-26-BE
• Date of registration: 28/09/2006
• Prospective Registration: Yes
• Primary sponsor: ONO Pharmaceutical Co.,Ltd
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 13/11/2006
• Target sample size: 392
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002660-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria, Belgium, France, Germany, Italy, Netherlands, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
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)
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 = 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
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:
1)Presence of a tracheotomy,mechanical ventilation or non-invasive ventilation as evidenced by a score of = 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 of the protocol, 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 of the protocol, for one week prior to Visit 1 (screening visit)
4)A clinically relevant medical history or presence of respiratory disease 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis
MedDRA version: 8.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis

Intervention(s)

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-2506
Other descriptive name: (2R)-2-Propyloctanoic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): The primary efficacy endpoint is defined as the slope of respiratory function (SVC expressed as a percentage of the predicted value) over 12 months.

Main Objective: The primary objective of this trial will be to evaluate the effect of ONO-2506PO(1200 mg once daily) on the slope of respiratory function (slow vital capacity (SVC) expressed as a percentage of the predicted value) over 12 months compared with placebo group.

Secondary Objective: The secondary objectives of this trial will be to evaluate the effect of ONO-2506PO(1200mg once daily) on:
Respiratory Function:
The slope of respiratory function(SVC expressed as a percentage of the predicted value) over 18 months
Time to SVC reaching below 50% of the predicted value over 12 and 18 months
Survival:
Survival (defined as death) over 12 and 18 months
Death, tracheotomy or permanent assisted ventilation over 12 and 18 months
Functional status:
The slope of functional status using the ALS Functional Rating Scale(ALSFRS-R)over 12 and 18 months
Time to loss of function using ALSFRS-R over 12 and 18 months
Muscle Strength:
The slope of muscle strength using MRC muscle score over 12 and 18 months
Quality of life:
Quality of life (QoL) using EuroQoL (EQ-5D) over 12 and 18 months
Safety and Tolerability:
Vital signs,Physical examination,weight,12-Lead ECG, clinical laboratory tests and adverse events monitoring

Secondary ID(s)

ONO-2506POE014

2006-002660-26-GB