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Completed

NCT Number: NCT00072709

Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)

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).

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Belgium, Vilvoorde, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TCH346

Drug

Primary outcomes

  1. Rate of functional decline as defined by the ALS Functional Rating Scale-Revised

Secondary outcomes

  1. Survival time

  2. Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit except screening)

  3. Neurocognitive evaluation in a subset of patients(every visit except screening)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Nov 11, 2003
Registry last updated
Nov 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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