Amyotrophic Lateral Sclerosis
Conditions
Interventions
Product Code: TCH346
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: not established
CAS Number: 200189-97-5
Current Sponsor code: TCH346
Concentration unit: mg milligram(s)
Concentration
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In addition to having met the inclusion criteria described in the original protocol, to participate in the extension study, patients must: - have completed the original protocol, Study No. CTCH346A2211 - be capable of satisfying the requirements of the extension study protocol and must sign the informed consent after the nature of the extension study protocol has been fully explained. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria as described in the original protocol will remain applicable into the extension protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the long-term safety and tolerability of TCH346 at the most clinically effective dose (as determined by data analysis at the completion of Study 2211) administered once daily in patients with Amyotrophic Lateral Sclerosis.;Secondary Objective: - To determine the long-term efficacy of TCH346 based on clinical functionality (ALSFRS slope of progression) and survival. - To characterize the long term PK/PD relationship in ALS patients receiving the same TCH346 dose.;Primary end point(s): Primary Efficacy assessment is the rate of functional decline in ALS patients as defined by the slope of ALSFRS-R. The evaluations completed during the double-blind treatment phase will continue to be collected at specific intervals during the open-label phase. | — |
Countries
Germany, Italy, United Kingdom
Outcome results
None listed