Safety Extension Study of TRO19622 in ALS

• Register: ClinicalTrials.gov
• Last refreshed on: 5 December 2016
• Main ID: NCT01285583
• Date of registration: 26/01/2011
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: Safety Extension Study of TRO19622 in ALS
• Scientific title: An Open-label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With Riluzole
• Date of first enrolment: October 2010
• Target sample size: 271
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01285583
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
• Phase: Phase 2/Phase 3

Countries of recruitment

Belgium, France, Germany, Spain, United Kingdom

Contacts

• Name: Vincent Meininger, MD, PhD
• Affiliation: Groupe Hospitalier Pitie-Salpetriere

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients must have completed the 18-month safety and efficacy study of TRO19622 in
Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole (Protocol TRO19622
CL E Q 1015-1).

- Both the investigator and the patient will decide based on previous good tolerance
and other clinical grounds whether or not to participate to the open-label extension.

- If patients were on anti-vitamin K during the double-blind period, when entering the
open-label extension, coagulation tests should be monitored in exactly the same
conditions as if a new anticoagulant treatment was initiated and the dose of
anti-vitamin K should be adjusted accordingly.

- Patients enrolling from this prior safety and efficacy study must:

- If female of childbearing age of potential, continue to use adequate birth
control methods and have a negative serum pregnancy test at the preceding
double-blind protocol termination visit. Male and female partners must agree to
use an effective method of birth control during their participation in the trial
and for at least 15 days after the last IMP dose. Both partners must use
reliable methods of contraception with 2 independent methods. The following
measures are acceptable: Hormone contraceptives (e.g. oral contraceptives or
comparable methods), intrauterine device, condoms with spermicidal coating or in
combination with spermicidal creams, total abstinence or sterilisation performed
in the past.

- Be able to follow the investigator's instructions and be able to comply with the
visit schedule and visit requirements; and

- Sign a written informed consent.

Exclusion Criteria:

Patients may not participate in this study if they have an ongoing, unresolved, clinically
significant medical problem (including patients having experienced serious adverse events
or non-serious, but medically significant adverse events during the preceding safety and
efficacy study that was assessed to be related to the study medication by the
investigator) that in the judgment of the investigator would make it unsafe for the
patient to participate in the trial.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: TRO19622

Primary Outcome(s)

The primary outcome measure will be the safety assessment. [Time Frame: Safety assessment will be calculated from the date of enrollment for a maximum of 15 months.]

Secondary Outcome(s)

Secondary Outcome Measures [Time Frame: Every 3 month, from the date of enrollment for a maximum of 15 months.]

Secondary ID(s)

TRO19622 CL E Q 1425-1

WN29852

Source(s) of Monetary Support

Please refer to primary and secondary sponsors