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Colchicine for Amyotrophic Lateral Sclerosis

NCT03693781 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-03-01

No results posted yet for this study

Summary

The study evaluates the effects of two different Colchicine doses (0.01mg/kg/day or 0.005 mg/kg/day) compared to placebo in Amyotrophic Lateral Sclerosis (ALS) patients. Disease progression as defined by changes in ALSFRS-r is the primary outcome measure. Other measures of clinical progression and survival, together with safety and tolerability of Colchicine in ALS patients will be assessed.

Conditions

Interventions

DRUG

Colchicine 1 MG Oral Tablet

Colchicine tablets depending on arm (0.01 mg/kg/day, 0.005 mg/kg/day, placebo) and on weight (\>70 kg or \<71 kg) for 30 weeks of duration.

DRUG

Colchicine 1 MG Oral Tablet

Colchicine tablets depending on arm (0.01 mg/kg/day, 0.005 mg/kg/day, placebo) and on weight (\>70 kg or \<71 kg) for 30 weeks of duration.

DRUG

Placebo Oral Tablet

Corresponding tablets for 30 weeks

Sponsors & Collaborators

  • University of Modena and Reggio Emilia

    collaborator OTHER

  • University of Turin, Italy

    collaborator OTHER

  • Istituto Auxologico Italiano

    collaborator OTHER

  • IRCCS National Neurological Institute "C. Mondino" Foundation

    collaborator OTHER

  • University of Bari

    collaborator OTHER

  • IRCCS San Raffaele

    collaborator OTHER

  • University of Padova

    collaborator OTHER

  • University of Milan

    collaborator OTHER

  • Istituto Di Ricerche Farmacologiche Mario Negri

    collaborator OTHER

  • University of Campania Luigi Vanvitelli

    collaborator OTHER

  • Catholic University of the Sacred Heart

    collaborator OTHER

  • Azienda Ospedaliero-Universitaria di Modena

    lead OTHER

Principal Investigators

  • Jessica Mandrioli · Azienda Ospedaliero-Universitaria di Modena

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-10
Primary Completion
2022-04-14
Completion
2023-01-03

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03693781 on ClinicalTrials.gov