Amyotrophic Lateral Sclerosis (ALS)Phase 2NCT01277315
Safety and Tolerability of Anakinra in Combination With Riluzol in Amyotrophic Lateral Sclerosis
A Phase 2 study testing Anakinra in people with Amyotrophic Lateral Sclerosis (ALS), run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Amyotrophic Lateral Sclerosis (ALS) is an adult neurodegenerative disease that is caused by a selective degeneration of the motor nerve cells in the cortex and myelon. As a result of motor neurodegeneration, a progredient paralysis of the extremities and of the speaking, swallowing, and breathing musculature develops. 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?
- Anakinra
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to Jun 2012
- Phase
- Phase 2
- 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
- Patients between 18 and 80 years of age
- Clinical diagnosis of amyotrophic lateral sclerosis with predominant affection of the lower motor neuron or the clinical ALS variant of progressive muscular atrophy (PMA)
- Clinical signs of lower motor neuron degeneration in at least one anatomic region beyond the brain stem
- Sporadic and familial ALS
- Onset of paresis six months to four years before study inclusion
- Treatment with riluzol 100mg/d at least 1 month before study inclusion
Who cannot join
- Diagnosis of amyotrophic lateral sclerosis with predominant affection or the upper motor neuron without clinical signs of a concurrent affection of the lower motor neuron in at least one anatomic region beyond the brain stem (spastic ALS) - Diagnosis of primary lateral sclerosis (PLS)
- Patients with known intolerance to anakinra, riluzol or one of the additives
- Clinically severe hypoventilation syndrome with vital capacity < 50%
- Pregnancy or breastfeeding
- Continuous non-invasive ventilation with ventilator-free time < 2 hours - Tracheotomy and mechanical ventilation
- Laboratory parameters outside the normal range that correspond to a clinically severe cardiovascular, pulmological, hematological, hepatological, metabolic or renal disease
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- Malignancies
- Severe renal insufficiency (creatinine clearance < 30 ml/min)
- History of recurrent infections or a disease that may predispose to infections
- Severe neutropenia (absolute neutrophil count < 1.5 x 109/l)
- Monoclonal gammopathy of unknown significance
- Infections including infections with HIV and hepatitis B and C
- Dementia and unable to give informed consent
- History of epilepsy and epileptic seizures
- Contraindication to E coli-derived proteins, anakinra or any components of the product
- Concurrent therapy of anakinra and etanercept or other TNF blocking agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Safety and Tolerability Trial to Evaluate a Subcutaneous Injection Solution of 100 mg of Anakinra in Combination With Riluzol in Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS) is an adult neurodegenerative disease that is caused by a selective degeneration of the motor nerve cells in the cortex and myelon. As a result of motor neurodegeneration, a progredient paralysis of the extremities and of the speaking, swallowing, and breathing musculature develops. ALS leads to death by respiratory insufficiency in a mean course of 3-5 years. So far, Riluzole is the only approved neuroprotective medication which effects a slight lifespan prolongation of 1.5 - 2.5 months. Riluzole inhibits the presynaptic glutamate release and lowers the level of glutamate liberated by activated microglia.
The researchers propose an investigational therapy of ALS with subcutaneous administration of 100 mg of Anakinra. The neuronal inflammation is a crucial pathogenetic factor of the motor neuron degeneration. Inflammatory processes are detectable in sporadic ALS, in the autosomal-dominant form of ALS and in transgenic mouse model. The rationale of this clinical trial is based on the anti-inflammatory effect of Anakinra. One of the key mediators of inflammatory response is Interleukin-1. Anakinra is a recombinant produced Interleukin-1 receptor antagonist. This gives Anakinra anti-inflammatory attributes that presumably reduce motor neuron degeneration and disease progression.
Read the detailed description
Open Safety and Tolerability study to evaluate a subcutaneous application 100 mg of Anakinra in combination with Riluzol in Amyotrophic Lateral Sclerosis.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- Anakinra
- Keywords
- ALS, Anakinra, Kineret, Progressive Muscular Atrophy, PMA, Safety Trial, Tolerability Trial
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraDrug
Open Safety and Tolerability study to evaluate a subcutaneous application 100 mg of Anakinra in combination with Riluzol in Amyotrophic Lateral Sclerosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Severity of adverse events (AE)
Measured: 1 month
Number and Severity of serious adverse events (SAE)
Measured: 1 month
Number and Severity of adverse drug reactions (ARD)
Measured: 1 month
Number and Severity of unexpected adverse drug reactions (UADR)
Measured: 1 month
Number and Severity of serious adverse drug reactions (SADR)
Measured: 1 month
Number and Severity of suspected unexpected serious adverse reaction (SUSAR)
Measured: 1 month
Pathological laboratory parameters
Measured: 1 month
Secondary outcomes (1)
Long Term Tolerability and Safety of Anakinra in ALS Patients
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Max Planck Institute for Infection Biology
- Responsible party
- Principal investigator, Thomas Meyer, MD, Charite University, Berlin, Germany
- Investigators
- Thomas Meyer, MD, Principal investigator, Charité University Hospital, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277315
- Sponsor's protocol ID
- ANA-ALS01
- Status last verified
- Feb 2024
- First submitted
- 13 Jan 2011
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Maier A, Deigendesch N, Muller K, Weishaupt JH, Krannich A, Rohle R, Meissner F, Molawi K, Munch C, Holm T, Meyer R, Meyer T, Zychlinsky A. Interleukin-1 Antagonist Anakinra in Amyotrophic Lateral Sclerosis--A Pilot Study. PLoS One. 2015 Oct 7;10(10):e0139684. doi: 10.1371/journal.pone.0139684. eCollection 2015.
PubMed 26444282
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Safety and Tolerability Trial to Evaluate a Subcutaneous Injection Solution of 100 mg of Anakinra in Combination With Riluzol in Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT01277315
- Acronym / sponsor ID
- ANA-ALS01
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Keywords
- ALS, Anakinra, Kineret, Progressive Muscular Atrophy, PMA, Safety Trial, Tolerability Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Max Planck Institute for Infection Biology
- Study start
- Feb 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 Jan 2011 (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 an adult neurodegenerative disease that is caused by a selective degeneration of the motor nerve cells in the cortex and myelon. As a result of motor neurodegeneration, a progredient paralysis of the extremities and of the speaking, swallowing, and breathing musculature develops. ALS leads to death by respiratory insufficiency in a mean course of 3-5 years. So far, Riluzole is the only approved neuroprotective medication which effects a slight lifespan prolongation of 1.5 - 2.5 months. Riluzole inhibits the presynaptic glutamate release and lowers the level of glutamate liberated by activated microglia.
The researchers propose an investigational therapy of ALS with subcutaneous administration of 100 mg of Anakinra. The neuronal inflammation is a crucial pathogenetic factor of the motor neuron degeneration. Inflammatory processes are detectable in sporadic ALS, in the autosomal-dominant form of ALS and in transgenic mouse model. The rationale of this clinical trial is based on the anti-inflammatory effect of Anakinra. One of the key mediators of inflammatory response is Interleukin-1. Anakinra is a recombinant produced Interleukin-1 receptor antagonist. This gives Anakinra anti-inflammatory attributes that presumably reduce motor neuron degeneration and disease progression.
Detailed description
Open Safety and Tolerability study to evaluate a subcutaneous application 100 mg of Anakinra in combination with Riluzol in Amyotrophic Lateral Sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients between 18 and 80 years of age
- Clinical diagnosis of amyotrophic lateral sclerosis with predominant affection of the lower motor neuron or the clinical ALS variant of progressive muscular atrophy (PMA)
- Clinical signs of lower motor neuron degeneration in at least one anatomic region beyond the brain stem
- Sporadic and familial ALS
- Onset of paresis six months to four years before study inclusion
Key exclusion criteria (16 listed)
- Diagnosis of amyotrophic lateral sclerosis with predominant affection or the upper motor neuron without clinical signs of a concurrent affection of the lower motor neuron in at least one anatomic region beyond the brain stem (spastic ALS) - Diagnosis of primary lateral sclerosis (PLS)
- Patients with known intolerance to anakinra, riluzol or one of the additives
- Clinically severe hypoventilation syndrome with vital capacity < 50%
- Pregnancy or breastfeeding
- Continuous non-invasive ventilation with ventilator-free time < 2 hours - Tracheotomy and mechanical ventilation
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 |
|---|---|---|
| AnakinraOpen Safety and Tolerability study to evaluate a subcutaneous application 100 mg of Anakinra in combination with Riluzol in Amyotrophic Lateral Sclerosis. | Drug | – |
Primary outcome
Number and Severity of adverse events (AE)
Time frame: 1 month
Number and Severity of serious adverse events (SAE)
Time frame: 1 month
Number and Severity of adverse drug reactions (ARD)
Time frame: 1 month
Number and Severity of unexpected adverse drug reactions (UADR)
Time frame: 1 month
Number and Severity of serious adverse drug reactions (SADR)
Time frame: 1 month
Number and Severity of suspected unexpected serious adverse reaction (SUSAR)
Time frame: 1 month
Pathological laboratory parameters
Time frame: 1 month
1 secondary outcome
Long Term Tolerability and Safety of Anakinra in ALS Patients
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Derived from this study: PubMed 26444282Maier A, Deigendesch N, Muller K, Weishaupt JH, Krannich A, Rohle R, Meissner F, Molawi K, Munch C, Holm T, Meyer R, Meyer T, Zychlinsky A. Interleukin-1 Antagonist Anakinra in Amyotrophic Lateral Sclerosis--A Pilot Study. PLoS One. 2015 Oct 7;10(10):e0139684. doi: 10.1371/journal.pone.0139684. eCollection 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.
Thomas Meyer, MD principal investigator
Charité University Hospital, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anakinra in people with Amyotrophic Lateral Sclerosis (ALS), run by Charite University, Berlin, Germany at 1 site in Germany.
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 16 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: finished, as of the sponsor's last update on 14 Feb 2024. 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 Germany. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Severity of adverse events (AE) (time frame: 1 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01277315, which also lists 1 linked publication.
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 14 Feb 2024.