Clinical trial: Clenbuterol on Motor Function in Individuals With Amyotrophic Lateral Sclerosis (NCT04245709)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of possible or more definite ALS according to the El Escorial criteria

          -  SVC >50% of predicted for age, height and gender.

          -  At least four of 12 ALSFRS-R questions scored as 2 or 3 at screening.

          -  Diminished but measurable grip strength (1) in at least one hand (females:10-50
             pounds; males, 10-70 pounds).

          -  Taking riluzole at a stable dose or not taking riluzole at screening.

          -  On Radicava at a stable dose for at least 30d or not taking this

          -  Life expectancy at least 6 months

          -  Able to swallow tablets without crushing.

          -  Age: 18+ years at enrollment.

          -  Subjects are capable of giving written consent.

          -  If sexually active, must agree to use contraceptive or abstinence for duration of
             treatment

          -  Females of child bearing age must have negative pregnancy test at screening

        Exclusion Criteria:

          -  Concurrent illness or laboratory abnormalities that could confound the measurement of
             ALS progression or interfere with the ability to complete the study.

          -  Taking any investigational study drug within 30 days of screening or five half-lives
             of the prior agent.

          -  No previous exposure to clenbuterol.

          -  Pregnancy

          -  Clinically relevant EKG abnormality (arrhythmia, cardiomyopathy)

          -  Tachycardia (resting heart rate greater than 100 beats per minute)

          -  History of seizure disorder

          -  Hyperthyroidism

          -  Pheochromocytoma

          -  Pregnancy

          -  Have any other co-morbid conditions that in the opinion of the study investigator,
             places the participant at increased risk of complications, interferes with study
             participation or compliance, or confounds study objectives

          -  History of hypersensitivity to 2-agonist drugs such as albuterol, levalbuterol
             (Xopenex), bitolterol (Tornalate), pirbuterol (Maxair), terbutaline, salmeterol
             (Serevent).

          -  The use of the following concomitant meds is prohibited during the study:

        diuretics (furosemide, Lasix), digoxin (digitalis, Lanoxin);blockers such as atenolol
        (Tenormin), metoprolol (Lopressor), and propranolol (Inderal); tricyclic antidepressants
        such as amitriptyline (Elavil, Etrafon), doxepin (Sinequan), imipramine (Janimine,
        Tofranil), and nortriptyline (Pamelor); MAO inhibitors such as isocarboxazid (Marplan),
        phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine
        (Parnate); or other bronchodilators such as albuterol (Ventolin), levalbuterol (Xopenex),
        bitolterol (Tornalate), pirbuterol (Maxair), terbutaline (Brethine, Bricanyl), salmeterol
        (Serevent), isoetherine (Bronkometer), metaproterenol (Alupent, Metaprel), or isoproterenol
        (Isuprel Mistometer).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? Entailment