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Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS

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ClinicalTrials.gov Identifier: NCT04057898
Recruitment Status : Not yet recruiting
First Posted : August 15, 2019
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
MediciNova

Brief Summary:
A Phase 2b/3 multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and tolerability of MN-166 given to ALS participants for 12 months followed by a 6-month open-label extension phase.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: MN-166 Drug: placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 12 Month Clinical Trial to Evaluate the Efficacy and Safety of MN-166 (Ibudilast) Followed by an Open-Label Extension Phase in Subjects With Amyotrophic Lateral Sclerosis
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
Experimental: MN-166
Subjects will take MN-166 10 mg capsules, up to 50 mg twice a day, along with a stable dose of riluzole, daily for 12 months.
Drug: MN-166
Subjects will take MN-166 with a stable dose of riluzole for 12 months followed by a 6-month open-label extension phase.
Other Name: ibudilast

Placebo Comparator: placebo
Subjects will take up to 5 matching placebo capsules twice a day, along with a stable dose of riluzole, daily for 12 months.
Drug: placebo
Subjects will take matching placebo with a stable dose of riluzole for 12 months followed by a 6-month open-label extension phase.




Primary Outcome Measures :
  1. Change from baseline in ALSFRS-R score at Month 12 (or last measurement before death in case of censoring) and survival time. [ Time Frame: 12 months ]
    The amyotrophic lateral sclerosis functional rating scale-revised, or ALSFRS-R, measures the functional status of subjects with ALS. It is based on 12 items, each of which is rated on a 5-point scale (0 to 4). The rate of total functional disability thus ranges from 0 (maximum disability) to 48 (normal function) points.


Secondary Outcome Measures :
  1. Mean change from baseline of muscle strength measured by hand-held dynamometry [ Time Frame: Baseline, Treatment Phase Week 6, Months 3, 6, 9 and12 time points. ]
    Hand-held dynamometry, or HHD, is used to measure the force generated by each muscle. The scale ranges from 0 (no visible movement of the part) to 10 (holds test position against strong pressure). Thus, the higher the total score, the higher muscle strength is observed.

  2. Mean change from baseline on quality of life assessed by ALSAQ-5 at Month 12 [ Time Frame: 12 months ]
    The Amyotrophic Lateral Sclerosis Assessment Questionnaire, or ALSAQ-5, is a patient self-report questionnaire specifically designed to measure 5 areas of health: physical mobility, activities of daily living and independence, eating and drinking, communication and emotional functioning. The subject is asked about 5 different areas of difficulties in their daily lives: ability to stand up, use of limbs, consuming solid food, level of speech coherence, and degree of hope about the future.Each question provides 5 choices from which to choose: Never, Rarely, Sometimes, Often, and Always or cannot do at all.

  3. Mean change from baseline of functional activity measured by ALSFRS-R at Month 12 [ Time Frame: 12 months ]
    The ALSFRS-R assessment tool measures the functional status of subjects with ALS. It is based on 12 items, each of which is rated on a 5-point scale (0 to 4). The rate of total functional disability thus ranges from 0 (maximum disability) to 48 (normal function) points. In this context, the ALSFRS-R total score change (lower, same, higher) is documented.

  4. Responders, measured in percent of subjects overall, whose ALSFRS-R total score was stable or improved [ Time Frame: 12 months ]
    Proportion of subjects in which ALSFRS-R total score was stable or improved.

  5. Time to survival [ Time Frame: 12 months ]
    Defined by death or permanent dependency to ventilator or tracheostomy.

  6. Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: 12 months ]
    The incidence of treatment-emergent adverse events (TEAEs), severity (mild, moderate, severe), as well as relationship to study treatment (not related, possibly related, probably related) and whether they are considered serious.

  7. Changes from Baseline in Laboratory Values [ Time Frame: 12 months ]
    Incidence of out-of-normal-range values and markedly abnormal change from baseline in laboratory safety test variables by treatment group.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects age 18 to 80 years, inclusive;
  • Diagnosis of familial or sporadic ALS as defined by the El Escorial-Revised (2000) research diagnostic criteria for ALS [clinically definite, clinically probable, probable-laboratory-supported];
  • ALS onset of ≤ 18 months from first clinical signs of weakness prior to screening;
  • Slow vital capacity ≥ 70% of predicted at screening
  • Currently on a stable dose of riluzole for at least 30 days prior to initiation of study drug;
  • Able to swallow study medication capsules;
  • No known allergies to the study drug or its excipients;
  • Received pneumococcal vaccine within 6 years prior to starting clinical trial.

Exclusion Criteria:

  • ALSFRS-R score of ≤ 1 on more than one item in the assessment's individual components;
  • Current use or treated with Edaravone® ≤ 3 months prior to signing consent;
  • Current use or treated with Nuedexta® ≤ 3 months prior to signing consent;
  • Current use or treated with Methylcobalamin Vitamin B12 ≤ 3 months prior to signing consent
  • Poor peripheral venous access that will limit the ability to draw blood as judged by the Investigator;
  • Use of tracheostomy, tracheostomy invasive mechanical ventilation [TIMV].

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Responsible Party: MediciNova
ClinicalTrials.gov Identifier: NCT04057898     History of Changes
Other Study ID Numbers: MN-166-ALS-2301
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MediciNova:
ALS
MN-166
ibudilast
amyotrophic lateral sclerosis
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Ibudilast
Riluzole
Anticonvulsants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Platelet Aggregation Inhibitors