Clinical trial: Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALS (NCT00868166)

Eligibility criteria:
Inclusion Criteria:

          -  Patients with sporadic or familial Amyotrophic Lateral Sclerosis

          -  Patients with a clinical diagnosis of laboratory-supported probable, probable, or
             definite ALS according to the modified El Escorial criteria8.

          -  Have signed an Informed Consent to participate to the trial before any study related
             procedure has taken place.

          -  Be of age >18 (exclusive) and < 80 years (inclusive).

          -  If a female, not lactating, has a negative pregnancy test and agrees to use an
             effective method of birth control.

          -  Onset of ALS Symptoms (weakness) for more than 6 months (inclusive) and less than 36
             months(inclusive).

          -  Slow vital capacity (SVC), measured three times, one of the measure being >/= 70% of
             that predicted.

          -  Treated with riluzole at the stable dose of 50 mg bid for at least 30 days before
             enrolment.

        Exclusion Criteria:

          -  Tracheostomy, invasive ventilation, or non invasive positive pressure ventilation
             (NIPPV).

          -  Gastrostomy.

          -  Evidence of major psychiatric disorder or clinically evident dementia.

          -  Diagnosis of a neurodegenerative disease in addition to ALS.

          -  Have a current medication that could interfere with TRO19622 pharmacokinetics:
             tamoxifene.

          -  Have current medications that could interfere with TRO19622 absorption such as
             ezetimibe, bile salts chelators (cholesteramine), fibrates, phytosterols, niacin
             (vitamin B3),fish oils. Have a current medication of lipid lowering agents other than
             statins.

          -  Known hypersensitivity to any component of the study drug.

          -  Patients with known intolerance or contra-indication to riluzole.

          -  Have a recent history (within the previous 6 months) or current evidence of alcohol or
             drug abuse.

          -  Have concurrent unstable disease involving any system eg, carcinoma other than basal
             cell carcinoma, any cardiac dysrhythmia, myocardial infarction, clinical or ECG signs
             of myocardial ischemia, cardiac insufficiency, angina symptoms, current symptoms of
             Coronary Artery Disease, or any other condition that in the opinion of the
             Investigator would make the patient unsuitable for study participation.

             . In Germany: Have any cardiac dysrhythmia, myocardial infarction, clinical or ECG
             signs of myocardial ischemia, cardiac insufficiency, angina symptoms, current symptoms
             of Coronary Artery Disease or any cardiovascular illness known or identified at the
             screening or inclusion visits, or have concurrent unstable disease involving any
             system eg, carcinoma other than basal cell carcinoma or any other condition that in
             the opinion of the Investigator would make the patient unsuitable for study
             participation.

          -  Having a baseline QTc (Bazett) > 450 msec for males and > 470 msec for females.

          -  Patients with known hepatitis B/C or HIV positive serology.

          -  Be pregnant female or lactating.

          -  Have renal impairment defined as blood creatinine > 1:5 X upper limit of normal.

          -  Have hepatic impairment and/or liver enzymes (ALAT or ASAT) > 3 X ULN.

          -  Hemostasis disorders or current treatment with oral anticoagulants.

          -  Be possibly dependent on the Investigator or the Sponsor (eg, including, but not
             limited to, affiliated employee).

          -  Participated in any other investigational drug or therapy study with a non approved
             medication, within the previous 3 months.

          -  Patients without Social Security Insurance (France).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

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? Entailment