NCT00072709

Brief Summary

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
551

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_2

Geographic Reach
9 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 11, 2003

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
Last Updated

November 24, 2011

Status Verified

November 1, 2011

Enrollment Period

1.3 years

First QC Date

November 7, 2003

Last Update Submit

November 22, 2011

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALSLou Gehrig's disease

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • 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)

Interventions

TCH346DRUG

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Novartis USA

East Hanover, New Jersey, 07936, United States

Location

Novartis Belgium

Vilvoorde, Belgium

Location

Novartis CANADA

Dorval, Quebec, Canada

Location

Novartis France

Rueil-Malmaison, France

Location

Novartis Germany

Nuremberg, Germany

Location

Novartis Italy

Saronno, Italy

Location

Novartis Netherlands

Arnhem, Netherlands

Location

Novartis Switzerland

Bern, Switzerland

Location

Novartis UK

Frimley, United Kingdom

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

dibenzo(b,f)oxepin-10-ylmethyl-methyl-prop-2-ynyl-amine

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2003

First Posted

November 11, 2003

Study Start

September 1, 2003

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

November 24, 2011

Record last verified: 2011-11

Locations

FR(1)CH(1)GB(1)BE(1)US(1)NL(1)CA(1)DE(1)IT(1)