A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with Amyotrophic Lateral Sclerosis.

Phase 3

Completed

• Conditions: Disease of nerve cells that control muscles; Neurodegenerative syndrome; 10029317

• Registration Number: NL-OMON53712
• Lead Sponsor: Ferrer Internacional, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

All patients:
1. who completed the full study period in the main ADORE study
(FAB122-CT-2001);
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.

Exclusion Criteria

This study has no exclusion criteria. The study is an open-label extension of
an already existing study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Nature, frequency and severity of Treatment Emergent Adverse Events</p><br>