A study to investigate the safety of FAB122 in patients with Amyotrophic Lateral Sclerosis on the long term.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2022-003050-32-IT
- Lead Sponsor
- Ferrer Internacional S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 225
All patients:
1.who completed the full study period in the main ADORE study (FAB122-CT-2001; (EudraCT number 2020-003376-40);
2.whom the investigator has no concern and judges tolerable for the continued treatment with FAB122 from a risk and benefit point of view;
3.a female subject should not be able to become pregnant and needs to meet at least one of the following criteria:
-female subject who is not of reproductive potential is eligible without requiring the use of contraception. A woman is considered not having childbearing potential when becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
-female who is of reproductive potential and has a negative pregnancy test at screening and at baseline and is non-lactating. A female subject who is of reproductive potential agrees to use (or have their partner use) adequate birth control methods starting from the time of consent through 30 days after the last dose of study therapy. Longer periods of birth control may be required per local requirements. Acceptable methods of birth control include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device in place for =3 months, intrauterine hormone-releasing system, bilateral tubal occlusion or vasectomised partner.
4.a male patient must:
-agree he will not donate sperm during the study and until 104 days after the last dose, AND use a condom during sexual intercourse with pregnant or non-pregnant women of childbearing potential (WOCBP) partner even if he is vasectomized.
-in addition WOCBP partner of the male patient must use the following acceptable methods of birth control during the study and until 104 days after the last dose: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device in place for =3 months, intrauterine hormone-releasing system, bilateral tubal occlusion or vasectomised partner;
5.providing 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 188
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37
Not applicable, as study is an open-label extension of an already existing study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the long-term safety of FAB122 in patients with ALS.;Secondary Objective: 1.To evaluate the effect of treatment with FAB122 on overall survival; <br>2.To evaluate the effect of treatment with FAB122 on disease progression in patients with ALS;<br>3.To evaluate the effect of treatment with FAB122 on cognitive functioning;<br>4.To evaluate the effect of treatment with FAB122 on quality of life (QoL).<br>;Primary end point(s): Nature, frequency and severity of Treatment Emergent Adverse Events.;Timepoint(s) of evaluation of this end point: Throughout whole study duration.
- Secondary Outcome Measures
Name Time Method