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NCT03693781: Co-ALS

Colchicine for Amyotrophic Lateral Sclerosis

Completed Phase 2 Last updated 1 March 2023
What this trial tests

Phase 2 trial testing Colchicine 1 MG Oral Tablet in Amyotrophic Lateral Sclerosis in 54 participants. Completed in 3 January 2023.

Timeline
10 April 2019
Primary endpoint
14 April 2022
3 January 2023

Quick facts

Lead sponsorAzienda Ospedaliero-Universitaria di Modena
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment54
Start date10 April 2019
Primary completion14 April 2022
Estimated completion3 January 2023
Sites8 locations across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Azienda Ospedaliero-Universitaria di Modena — full company profile →

Who can join

Adults 18 to 80, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting autophagy in disease: established and new strategies.
    Kocak M, Ezazi Erdi S, Jorba G, Maestro I, et al · · 2022 · cited 164× · PMID 34241570 · DOI 10.1080/15548627.2021.1936359
  2. Combating deleterious phase transitions in neurodegenerative disease.
    Darling AL, Shorter J. · · 2021 · cited 61× · PMID 33549703 · DOI 10.1016/j.bbamcr.2021.118984
  3. Proteostasis and ALS: protocol for a phase II, randomised, double-blind, placebo-controlled, multicentre clinical trial for colchicine in ALS (Co-ALS).
    Mandrioli J, Crippa V, Cereda C, Bonetto V, et al · · 2019 · cited 56× · PMID 31152038 · DOI 10.1136/bmjopen-2018-028486
  4. Aberrant Phase Transitions: Side Effects and Novel Therapeutic Strategies in Human Disease.
    Verdile V, De Paola E, Paronetto MP. · · 2019 · cited 56× · PMID 30967892 · DOI 10.3389/fgene.2019.00173
  5. Comprehensive Research on Past and Future Therapeutic Strategies Devoted to Treatment of Amyotrophic Lateral Sclerosis.
    Sever B, Ciftci H, DeMirci H, Sever H, et al · · 2022 · cited 51× · PMID 35269543 · DOI 10.3390/ijms23052400
  6. New developments and opportunities in drugs being trialed for amyotrophic lateral sclerosis from 2020 to 2022.
    Jiang J, Wang Y, Deng M. · · 2022 · cited 48× · PMID 36518658 · DOI 10.3389/fphar.2022.1054006
  7. Emerging Therapies and Novel Targets for TDP-43 Proteinopathy in ALS/FTD.
    Hayes LR, Kalab P. · · 2022 · cited 46× · PMID 35790708 · DOI 10.1007/s13311-022-01260-5
  8. Protein clearance strategies for disease intervention.
    Hommen F, Bilican S, Vilchez D. · · 2022 · cited 30× · PMID 34689261 · DOI 10.1007/s00702-021-02431-y

Verify or expand the search:

Other trials of Colchicine 1 MG Oral Tablet

Trials testing the same drug.

Other recruiting trials for Amyotrophic Lateral Sclerosis

Currently open trials in the same condition.

Other Azienda Ospedaliero-Universitaria di Modena trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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