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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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8 October 2021 |
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Main ID: |
EUCTR2007-004723-37-FR |
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Date of registration:
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06/02/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS).
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Scientific title:
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A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). |
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Date of first enrolment:
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15/04/2008 |
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Target sample size:
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273 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004723-37 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: Double-blind, parallel treatment phase followed by open-label phase.
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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France
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Germany
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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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 continued 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:
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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 9.1
Level: LLT
Classification code 10002026
Term: Amyotrophic lateral sclerosis
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Intervention(s)
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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: (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
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Primary Outcome(s)
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Primary end point(s): There is no primary ‘efficacy’ endpoint. Primary endpoint is safety (evaluated using AEs, death rates, occurrence of tracheotomy/PAV).
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Secondary Objective: There is no secondary objective
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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
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Secondary ID(s)
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2007-004723-37-DE
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ONO-2506POE015
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 15/04/2008
Contact:
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