A controlled objective investigation on the efficacy and safety of an infusion therapy for ALS patients, consisting of the combination of penicillin G and hydrocortisone.

Phase 1

Conditions: Patients suffereing from Amytrophic Lateral Sclerosis
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2017-001983-39-NL

Lead Sponsor: niversity Medical Centre Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Patients must be over 18 years of age.
2. Patients diagnosed with laboratory supported, clinically probable or definite ALS according to the World Federation of Neurology Revised El Escorial criteria (Brooks, 1994).
3. Disease duration from symptoms onset no longer than 24 months at the screening visit.
4. Patient with a FVC (Forced Vital Capacity) equal to or more than 80% predicted normal value for gender, height, and age at the screening visit
5. Patients must have bulbar involvement (defined as clinically evident dysarthria or a =1 point drop on questions 1-3 of the revised version of the ALS functional rating scale (ALS-FRS-R).
6. Patient treated with a stable dose of riluzole (100 mg/day) for at least 30 days prior to screening.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1. Patients with concomitant frontotemporal dementia (FTD).
2. Patients on non-invasive ventilation (NIV) or who underwent tracheotomy.
3. Patients with syphilis or a medical history of syphilis.
4. Patients with known penicillin allergy or patients with a positive penicillin allergy skin test.
5. Patients with a contra-indication for using penicillin (use of methotrexate, renal insufficiency).
6. Patients with a medical history of epilepsy.
7. Patients with a contra-indication for using hydrocortisone (uncontrolled hypertension or diabetes mellitus, ulcus ventriculi or ulcus duodeni, patients with acute infections)
8. In the case of a female with childbearing potential, the patient must not be pregnant or breast-feeding. Women of childbearing potential should use adequate contraception.