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CompletedNCT00925847LISLAUpdated Oct 31, 2012

Effect of Lithium Carbonate in Patients With Amyotrophic Lateral Sclerosis

A Phase 2 interventional study of lithium in Amyotrophic Lateral Sclerosis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-31.

Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
23
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to determine whether lithium is safe and effective in the treatment of ALS

Read the detailed description

Daily doses of lithium, have been found to delay progression of amyotrophic lateral sclerosis (ALS) in a 15-month study of 44 patients with ALS. At the end of the trial, about 30 percent of the patients that took riluzole had died, while all those receiving riluzole plus lithium had survived. the lithium group had slower progression as measure by a test of breathing (FVC) and strength.

This study will determine whether lithium in combination with riluzole delay progression of patients with amyotrophic lateral sclerosis disease in comparison of an historical cohort of ALS patients treated with riluzole alone.

02

Conditions studied

  • Amyotrophic Lateral Sclerosis

Keywords

  • Amyotrophic lateral sclerosis
  • Lithium
  • Survival
03

In context

Motor Neuron Disease

717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.

This study's enrollment of 23 is below the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.

Browse Motor Neuron Disease studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of clinically possible, clinically probable laboratory-supported, clinically probable or clinically definite ALS (according to WNF EL Escorial diagnostic criteria, revised according to the AIRLIE House Conference 1998)
  • Concomitant standard Riluzole therapy (50mg twice daily)
  • patients included in ALS reference center
  • women of childbearing age be non-lactating and surgically sterile or using a highly effective method of birth control and have a negative pregnancy test
  • capable of thoroughly understanding all information given and giving full informed consent according to GCP
  • Patients with gastrostomy

Exclusion criteria

Exclusion Criteria:

  • evidence of major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms
  • any medical condition known to contre-indicate lithium treatment (dysthyroid, cardiopathy, renal insufficiency)
  • presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
  • known hypersensitivity to any component of the study drugs
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    1

    Drug: lithium

Interventions

  • Druglithium

    lithium LP 400mg daily po (doses were adjusted during the study to maintain targeted blood levels.)

06

What researchers measure

Primary outcomes

  1. Survival in patients with ALS treated with lithium and riluzole compared to historical cohort (patients treated with riluzole alone )

    Time frame: 15 months

Secondary outcomes

  1. Functional Assessment Change in ALS Functional Rating Score (ALSFRS-R slope)

    Time frame: 15 months

  2. Muscle Strength Change in MMT score (MMT slope)

    Time frame: 15 months

  3. Rate of decline of respiratory function determined as SVC over the 15 month treatment period

    Time frame: 15 months

07

Study locations

1 site
  • Pitié-Salpêtrière Hospital
    Paris, 75013, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00925847
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jun 22, 2009
Start date
Jun 2009
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Oct 31, 2012

Study contacts

Lucette Lacomblez, MD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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