Immuno-modulation in Amyotrophic Lateral Sclerosis- a Phase II Study of Safety and Activity of Low Dose Interleukin-2

PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

December 31, 2015

Study Completion Date

May 31, 2016

Conditions
Amyotrophic Lateral Sclerosis
Interventions
DRUG

Placebo

Patients in this arm will receive sub-cutaneous injections of placebo (same vehicle as for experimental arms, and same volume) for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months).

DRUG

1.0 MIU IL-2 per day

Patients in this arm will receive sub-cutaneous injections corresponding to 1.0 MIU of IL-2 per injection for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months).

DRUG

2.0 MIU IL-2 per day

Patients in this arm will receive sub-cutaneous injections corresponding to 2.0 MIU of IL-2 per injection for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months).

Trial Locations (1)

34295

CHRU de Montpellier - Hôpital Gui de Chauliac, Montpellier

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Nīmes

OTHER

NCT02059759 - Immuno-modulation in Amyotrophic Lateral Sclerosis- a Phase II Study of Safety and Activity of Low Dose Interleukin-2 | Biotech Hunter | Biotech Hunter