Amyotrophic Lateral Sclerosis (ALS)NCT02424669
Neuroinflammation in Amyotrophic Lateral Sclerosis - Mechanisms and Therapeutic Perspectives: a Translational Pilot Study Among ALS Patients
A study testing ALS Functional rating Scale-revised (ALS FRS-R), slow vital capacity and Blood sample in people with Amyotrophic Lateral Sclerosis (ALS), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Amyotrophic Lateral Sclerosis (ALS) is the most common motor neuron diseases. It is considered as a rare disease with a prevalence of about 8 per 100,000 persons. Initiating in mid-life by progressive paralysis, it evolves rapidly into a generalized muscle wasting that leads irrevocably to death within 2 or 5 years of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- ALS Functional rating Scale-revised (ALS FRS-R), slow vital capacity and Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group 1 and Group 2:
- with sporadic ALS (without family history), recently diagnosed (onset of first symptoms < 24 months) group 1, not recently diagnosed (onset of first symptoms > 24 months) group 2
- Who meet the laboratory-supported probable, probable or definite form of ALS according to the El Escorial criteria
- Suffering from the spinal form of ALS
- Group 3:
- with an inflammatory peripheral neuropathy, or a non inflammatory peripheral neuropathy, recently diagnosed
Who cannot join
- Familial form of ALS
- Bulbar form and respiratory onset form of ALS
- Subjects with a clinically significant history of unstable or severe cardiac, oncologic, hepatic or renal disease, or other medically significant illness.
- Subjects with significant cognitive impairment, clinical dementia, or psychiatric illness.
- Female of childbearing potential (apart of patient using adequate contraceptive measures), pregnant or breast feeding
- Suspected inability to complete the study follow-up (foreign workers, transient visitors, tourists or any others for whom follow-up evaluation is not assured)
- Participation in any other clinical study within 30 days prior to the Screening Visit
- Persons deprived of freedom by judicial or administrative decision, hospitalized without their consent or for other reasons than the research, under legal protection or unable to express their consent
Trial locations and contacts
1 site in 1 country.
Joelle Micallef contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, 13005
Joelle Micallef, joelle.micallef@ap-hm.fr
About this study
Amyotrophic Lateral Sclerosis (ALS) is the most common motor neuron diseases. It is considered as a rare disease with a prevalence of about 8 per 100,000 persons. Initiating in mid-life by progressive paralysis, it evolves rapidly into a generalized muscle wasting that leads irrevocably to death within 2 or 5 years of clinical onset.
Since there is no cure for ALS, the management of the disease is supportive and palliative. Riluzole is the only drug that has been shown to extend survival by about three months. The identification of biomarkers sensitive to the progression of the disease might enhance the diagnostic and provide new drug targets.
Dysfunction of the immune system is a pathological hallmark of ALS. Increased levels of interferon gamma (IFNgamma) were found in the serum and cerebrospinal fluid (CSF) of ALS patients. However, the cell origin as well as the pathogenic influence of this peripheral source of IFNg is unknown. Thus, IFNgamma might have a role in the pathogenic process of ALS and might be a potential biomarker of the disease.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- ALS Functional rating Scale-revised (ALS FRS-R), slow vital capacity, Blood sample, Cerebrospinal Fluid (CSF) sample
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALS Functional rating Scale-revised (ALS FRS-R)Other
slow vital capacityOther
Blood sampleOther
Cerebrospinal Fluid (CSF) sampleOther
| Study group | Role | What they receive |
|---|---|---|
| recently diagnosed ALS patients | Experimental | Not described Receives: Other: ALS Functional rating Scale-revised (ALS FRS-R); Other: slow vital capacity; Other: Blood sample; Other: Cerebrospinal Fluid (CSF) sample |
| not recently diagnosed ALS patients | Experimental | Not described Receives: Other: ALS Functional rating Scale-revised (ALS FRS-R); Other: slow vital capacity; Other: Blood sample; Other: Cerebrospinal Fluid (CSF) sample |
| patients with peripheral neuropathy, recently diagnosed | Active comparator | Not described Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALS Functional rating Scale-revised (ALS FRS-R) score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2017 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle Desalbres, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424669
- Sponsor's protocol ID
- 2014-19
- Other IDs
- RCAPHM15_0132
- Status last verified
- Nov 2015
- First submitted
- 20 Apr 2015
- Last updated
- 17 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroinflammation in Amyotrophic Lateral Sclerosis - Mechanisms and Therapeutic Perspectives: a Translational Pilot Study Among ALS Patients
- ClinicalTrials.gov ID
- NCT02424669
- Acronym / sponsor ID
- 2014-19
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Amyotrophic Lateral Sclerosis (ALS) is the most common motor neuron diseases. It is considered as a rare disease with a prevalence of about 8 per 100,000 persons. Initiating in mid-life by progressive paralysis, it evolves rapidly into a generalized muscle wasting that leads irrevocably to death within 2 or 5 years of clinical onset.
Since there is no cure for ALS, the management of the disease is supportive and palliative. Riluzole is the only drug that has been shown to extend survival by about three months. The identification of biomarkers sensitive to the progression of the disease might enhance the diagnostic and provide new drug targets.
Dysfunction of the immune system is a pathological hallmark of ALS. Increased levels of interferon gamma (IFNgamma) were found in the serum and cerebrospinal fluid (CSF) of ALS patients. However, the cell origin as well as the pathogenic influence of this peripheral source of IFNg is unknown. Thus, IFNgamma might have a role in the pathogenic process of ALS and might be a potential biomarker of the disease.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| recently diagnosed ALS patients | Experimental | Other: ALS Functional rating Scale-revised (ALS FRS-R), Other: slow vital capacity, Other: Blood sample, Other: Cerebrospinal Fluid (CSF) sample |
| not recently diagnosed ALS patients | Experimental | Other: ALS Functional rating Scale-revised (ALS FRS-R), Other: slow vital capacity, Other: Blood sample, Other: Cerebrospinal Fluid (CSF) sample |
| patients with peripheral neuropathy, recently diagnosed | Active comparator | Other: Blood sample |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- with sporadic ALS (without family history), recently diagnosed (onset of first symptoms < 24 months) group 1, not recently diagnosed (onset of first symptoms > 24 months) group 2
- Who meet the laboratory-supported probable, probable or definite form of ALS according to the El Escorial criteria
- Suffering from the spinal form of ALS
- with an inflammatory peripheral neuropathy, or a non inflammatory peripheral neuropathy, recently diagnosed
Key exclusion criteria (8 listed)
- Familial form of ALS
- Bulbar form and respiratory onset form of ALS
- Subjects with a clinically significant history of unstable or severe cardiac, oncologic, hepatic or renal disease, or other medically significant illness.
- Subjects with significant cognitive impairment, clinical dementia, or psychiatric illness.
- Female of childbearing potential (apart of patient using adequate contraceptive measures), pregnant or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALS Functional rating Scale-revised (ALS FRS-R) | Other | not recently diagnosed ALS patients, recently diagnosed ALS patients |
| slow vital capacity | Other | not recently diagnosed ALS patients, recently diagnosed ALS patients |
| Blood sample | Other | not recently diagnosed ALS patients, patients with peripheral neuropathy, recently diagnosed, recently diagnosed ALS patients |
| Cerebrospinal Fluid (CSF) sample | Other | not recently diagnosed ALS patients, recently diagnosed ALS patients |
Primary outcome
ALS Functional rating Scale-revised (ALS FRS-R) score
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joelle Micallef contact
Urielle Desalbres study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALS Functional rating Scale-revised (ALS FRS-R), slow vital capacity and Blood sample in people with Amyotrophic Lateral Sclerosis (ALS), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joelle Micallef (joelle.micallef@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALS Functional rating Scale-revised (ALS FRS-R) score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.