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.

A placebo-controlled double blind randomized trial to investigate the efficacy and safety of the combination of Penicillin G / Hydrocortisone treatment in ALS patients (PHALS). - PHALS

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001983-39-NL

Enrollment

Unknown

Registered

2017-08-29

Start date

2017-09-28

Completion date

Unknown

Last updated

2017-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients suffereing from Amytrophic Lateral Sclerosis

Interventions

Trade Name: Benzylpenicillinenatrium Sandoz, poeder voor injectievloeistof Pharmaceutical Form: Powder for infusion Pharmaceutical form of the placebo: Infusion Route of administration of the placebo:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate efficacy and safety of the combination therapy penicilline G / Hydrocortisone in ALS patients;Secondary Objective: Not applicable;Primary end point(s): Change from baseline to week 45 in Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R).;Timepoint(s) of evaluation of this end point: Change from baseline to Week 45.	—

Secondary

Measure	Time frame
Secondary end point(s): 1. Survival defined as the time from randomization to the date of documented death or date of tracheotomy. 2. Change of slow Vital Capacity (sVC) from baseline to each time point (week 3, 11, 15, 23, 27, 35, 39 and 45). 3. Change in muscle strength from baseline to each time point 4. Change in plasma creatine level from baseline to each time point. 5. Time to next stage of the King’s staging system. 6. Time to gastrostomy defined as the time from randomization to the time of the gastrostomy. 7. Changes in score on the EQ-5D-5L. ;Timepoint(s) of evaluation of this end point: 1. Survival defined as the time from randomization to the date of documented death or date of tracheotomy. 2. Change of slow Vital Capacity (sVC) from baseline to each time point (week 3, 11, 15, 23, 27, 35, 39 and 45). 3. Change in muscle strength from baseline to each time point 4. Change in plasma creatine level from baseline to each time point. 5. Time to next stage of the King’s staging system. 6. Time to gastrostomy defined as the time from randomization to the time of the gastrostomy. 7. Changes in score on the EQ-5D-5L. 8. Safety: Number of Serious Adverse Events (SAEs), changes on clinical examination including vital signs and weight, laboratory exams (biochemistry and hematology).	—

Measure

Time frame

Secondary end point(s): 1. Survival defined as the time from randomization to the date of documented death or date of tracheotomy. 2. Change of slow Vital Capacity (sVC) from baseline to each time point (week 3, 11, 15, 23, 27, 35, 39 and 45). 3. Change in muscle strength from baseline to each time point 4. Change in plasma creatine level from baseline to each time point. 5. Time to next stage of the King’s staging system. 6. Time to gastrostomy defined as the time from randomization to the time of the gastrostomy. 7. Changes in score on the EQ-5D-5L. ;Timepoint(s) of evaluation of this end point: 1. Survival defined as the time from randomization to the date of documented death or date of tracheotomy. 2. Change of slow Vital Capacity (sVC) from baseline to each time point (week 3, 11, 15, 23, 27, 35, 39 and 45). 3. Change in muscle strength from baseline to each time point 4. Change in plasma creatine level from baseline to each time point. 5. Time to next stage of the King’s staging system. 6. Time to gastrostomy defined as the time from randomization to the time of the gastrostomy. 7. Changes in score on the EQ-5D-5L. 8. Safety: Number of Serious Adverse Events (SAEs), changes on clinical examination including vital signs and weight, laboratory exams (biochemistry and hematology).

—

Countries

Netherlands

Contacts

Public ContactClinical Trial Information

University Medical Centre Utrecht

T.Bunte-3@umcutrecht.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026