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Anakinra

Phase 2

Amyotrophic Lateral Sclerosis (ALS) | Small molecule | Neurology |Pulmonx Corporation|Last Updated: Feb 14, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Anakinra · 1 trial · 1 indication

Phase 2 1
NCT01277315Safety and Tolerability of Anakinra in Combination With Riluzol in Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis (ALS)
COMPLETED20 Analytics
PHASE2COMPLETED
Safety and Tolerability of Anakinra in Combination With Riluzol in Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS)
NCT0127731520
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Study Endpoints

Primary Endpoints

Number and Severity of adverse events (AE)
1 month
Number and Severity of serious adverse events (SAE)
1 month
Number and Severity of adverse drug reactions (ARD)
1 month
Number and Severity of unexpected adverse drug reactions (UADR)
1 month
Number and Severity of serious adverse drug reactions (SADR)
1 month
Number and Severity of suspected unexpected serious adverse reaction (SUSAR)
1 month
Pathological laboratory parameters
1 month

Secondary Endpoints

Long Term Tolerability and Safety of Anakinra in ALS Patients
1 month
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
AnakinraDRUGOpen Safety and Tolerability study to evaluate a subcutaneous application 100 mg of Anakinra in combination with Riluzol in Amyotrophic Lateral Sclerosis.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 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 ...

Countries:Germany
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