Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALS

• Status: Completed
• Trial end date: 2011-09-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the assay is to assess the safety and the efficacy of TRO19622 330 mg QD as add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, as compared to placebo, assessed by the 18-month survival rate.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche; Trophos
• Collaborator: European Commission
• Treatments: Riluzole

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).