Clinical trial: Safety Extension Study of TRO19622 in ALS (NCT01285583)

Eligibility 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.



Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? 0