Clinical trial: Study of Rasagiline in Patients With Amyotrophic Lateral Sclerosis (NCT01879241)

Eligibility criteria:
Inclusion Criteria:

          -  Possible, probable (clinically or laboratory) or definite ALS according to the revised
             version of the El Escorial World Federation of Neurology criteria

          -  Disease duration more than 6 months and less than 3 years (inclusive). Disease onset
             defined as date of first muscle weakness, excluding fasciculations and cramps

          -  Vital capacity more than 50% of normal (slow vital capacity; best of three
             measurements)

          -  Age: ≥ 18 years

          -  Continuously treated with 100 mg riluzole for at least four weeks

          -  Capable of thoroughly understanding all information given and giving full informed
             consent according to GCP

          -  Women of childbearing age must be non-lactating and surgically sterile or using a
             highly effective method of birth control and have a negative pregnancy test.
             Acceptable methods of birth control with a low failure rate i.e. less than 1% per
             year) when used consistently and correct are such as implants, injectables, combined
             oral contraceptives, hormonal intrauterine devices (IUDs), or double-barrier methods
             (condom or diaphragm with spermicidal agent or IUD), sexual abstinence or vasectomized
             partner

        Exclusion Criteria:

          -  Previous participation in another clinical study within the preceding 12 weeks

          -  Tracheostomy or assisted ventilation of any type during the preceding three months

          -  Gastrostomy

          -  Any medical condition known to have an association with motor neuron dysfunction which
             might confound or obscure the diagnosis of ALS

          -  Presence of any concomitant life-threatening disease or impairment likely to interfere
             with functional assessment

          -  Patients on sympathomimetic agents. This includes pseudoephedrine, phenylephrine,
             phenylpropanolamine, and ephedrine.

          -  Patients on analgesics with serotoninergic properties such as meperidine, tramadol,
             methadone and propoxyphene.

          -  Patients on serotonin reuptake inhibitors (SSRIs). This includes fluoxetine or
             fluvoxamine.

          -  Patients on dextromethorphan, St. John's wort, cyclobenzaprine or other MAO inhibitors
             (selective or non-selective)

          -  Patients taking Antidepressants

          -  Confirmed hepatic insufficiency or abnormal liver function (ASAT and/or ALAT greater
             than 3 times the upper limit of the normal range)

          -  Renal insufficiency (serum creatinine more than 2.26 mg/dL)

          -  Evidence of major psychiatric disorder or clinically evident dementia precluding
             evaluation of symptoms

          -  Known hypersensitivity to any component of the study drug

          -  Liable to be not cooperative or comply with the trial requirements (as assessed by the
             investigator), or unable to be reached in the case of emergency

          -  Female with childbearing potential, if no adequate contraceptive measures are used

          -  Pregnancy or breast-feeding females
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