| November 7, 2003 |
| November 29, 2007 |
| September 2003 |
| |
| Rate of functional decline as defined by the ALS Functional Rating Scale-Revised |
| Rate of functions decline in ALS patients as defined by the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised(ALSFRS-R) |
| Complete list of historical versions of study NCT00072709 on ClinicalTrials.gov Archive Site |
- Survival time
- Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit except screening)
- Neurocognitive evaluation in a subset of patients(every visit except screening)
|
- Survival assessed by the time to death, tracheotomy, intubation with artificial ventilation or 23 hours noninvasive ventilation (NPPV) for 7 consecutive days, which ever of these events occurs first
- Functional outcome measures which include pulmonary function as measured by Forced Vital Capacity(FVC)-Spirometry and manual muscle strength assessments (every visit except screening)
- Neurocognitive evaluation as measured by the Addenbrooke Cognitive examination (ACE) in a subset of patients(every visit except screening)
|
| |
| Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS) |
| A Randomized, Double-Blind, Placebo-Controlled, Stratified, Parallel-Group, Multicenter, Dose-Ranging Study Evaluating Four Oral Doses of TCH346 (1.0, 2.5, 7.5 and 15 mg) Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis |
This is a global multicenter study designed to evaluate the safety and clinical effects of 4 oral doses of TCH346 (1.0, 2.5, 7.5, and 15 mg) compared to placebo in patients with mild or mild to moderate stages of ALS. The study consists of 3 phases: screening (up to 2 weeks), run-in (16 weeks), and a double-blind treatment phase of variable duration (at least 24 weeks). |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Amyotrophic Lateral Sclerosis |
| Drug: TCH346 |
| |
| |
| |
| Completed |
| 500 |
| December 2004 |
|
Inclusion criteria:
- clinical diagnosis of laboratory-supported probable, probable, or definite ALS;
- sporadic or familial ALS;
- ALS symptom onset for no more than 3 yrs at study entry;
- FVC equal to or more than 70%;
- patients who are either riluzole naive or patients who are receiving concomitant treatment with riluzole at a stable dose of riluzole (50 mg bid) at study start.
Exclusion criteria:
- Known or suspected chronic infectious disease including HIV, hepatitis B, or hepatitis C.
- Clinically significant ECG abnormalities.
- Known hypersensitivity to study drug or related drugs (e.g. selegiline, MAO-A and B inhibitors, or tricyclic antidepressants).
- Patients treated with potent inhibitors of CYP1A2 or CYP3A4 (a list of such inhibitors will be provided to the investigator).
- Treatment with MAO-A and B inhibitors (including selegiline) within the past 30 days.
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| Both |
| 21 Years to 80 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Belgium, Canada, France, Germany, Italy, Netherlands, Switzerland, United Kingdom |
| |
| NCT00072709 |
|
| CTCH346A2211 |
| Novartis |
|
|
| Novartis |
| November 2007 |
