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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	13 June 2016
Main ID:	NCT02059759
Date of registration:	07/02/2014
Prospective Registration:	Yes
Primary sponsor:	Centre Hospitalier Universitaire de Nimes
Public title:	Immuno-modulation in Amyotrophic Lateral Sclerosis- a Phase II Study of Safety and Activity of Low Dose Interleukin-2 IMODALS
Scientific title:	Immuno-modulation in Amyotrophic Lateral Sclerosis- a Phase II Study of Safety and Activity of Low Dose Interleukin-2
Date of first enrolment:	September 2015
Target sample size:	36
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02059759
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Phase:	Phase 2

Countries of recruitment
France

Contacts

Name:	Raul Juntas-Morales, MD
Address:
Telephone:
Email:
Affiliation:	CHRU de Montpellier

Key inclusion & exclusion criteria

Inclusion Criteria:

- The patient has been correctly informed

- The patient must have given his/her informed and signed consent.

- The patient must be insured or beneficiary of a health insurance plan.

- The patient is at least 18 years old and less than 75 years old

- Probable, or laboratory-supported probable or definite ALS as defined by El Escorial
Revised ALS diagnostic criteria (according to Airlie House Conference 1988)

- Stable on riluzole treatment for more than 3 months with liver function test results
< 2ULN

- Disease duration = 5 years

- Vital capacity = 70% of normal

- Ability to swallow without the requirement for nasogastric or PEG feeding

- Agreement for patient to use an adequate method of contraception throughout the study
and for 2 weeks after post study visit

- The patient is available and willing to participate in seven study visits occurring
at the CHU within the next six months

Exclusion Criteria:

- The patient is participating in another interventional study

- Within the past three months, the patient has participated in another interventional

- The patient is in an exclusion period determined by a previous study

- The patient is under judicial protection

- The patient is an adult under guardianship

- The patient refuses to sign the consent

- It is impossible to correctly inform the patient

- Other life threatening disease

- Presence of contra-indicated concomitant treatments or with potential neuroprotective
benefit (see section 11.2 of the protocol)

- Presence of tracheostomy or non-invasive ventilation

- Use of Percutaneous endoscopic gastrostomy (PEG) or nasogastric tube

- Presence of clinical infection (treated or untreated)

- Positive serology for CMV, EBV (confirmed by viral load), or HIV

- Vaccination within 8 weeks prior to first experimental dosing

- Other disease precluding functional assessments

- Cancer within the past 5 years (except stable non-metastatic basal cell skin
carcinoma or in situ carcinoma of the cervix)

- Severe cardiac or pulmonary disease

- Documented auto-immune disorders except asymptomatic Hashimoto thyroiditis

- Women of child bearing age without contraception or pregnant or breast feeding

- Any clinically significant laboratory abnormality (excepting cholesterol,
triglyceride and glucose)

Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: 2.0 MIU IL-2 per day

Drug: Placebo

Drug: 1.0 MIU IL-2 per day

Primary Outcome(s)

CD4+ CD25+ CD127- FoxP3+(Treg) cells: change in percentage of total lymphocytes [Time Frame: Day 8]

Secondary Outcome(s)

CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes [Time Frame: Week 13]

CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes [Time Frame: Day 57]

effector T cells: number and % of CD4 cells [Time Frame: Day 1]

effector T cells: number and % of CD4 cells [Time Frame: Day 8]

MedDRA classification of all adverse events throughout the study [Time Frame: Week 25]

Presence/absence of abnormal vital signs [Time Frame: Day 1]

Presence/absence of a clinically significant abnormality among routine laboratory tests [Time Frame: Day 29]

Presence/absence of abnormal vital signs [Time Frame: Day 29]

Presence/absence of abnormal vital signs [Time Frame: Day 8]

Presence/absence of abnormal vital signs [Time Frame: Week 25]

Presence/absence of clinically significant abnormality on an electrocardiogram [Time Frame: Baseline (day 0 to day -15)]

Presence/absence of clinically significant abnormality on a lung x-ray [Time Frame: Week 13]

Presence/absence of clinically significant abnormality on an electrocardiogram [Time Frame: Week 13]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 33]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 6]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 30]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 35]

CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes [Time Frame: Day 8]

effector T cells: number and % of CD4 cells [Time Frame: Week 25]

Presence/absence of a clinically significant abnormality among routine laboratory tests [Time Frame: Day 57]

Presence/absence of a clinically significant abnormality among routine laboratory tests [Time Frame: Day 64]

Presence/absence of abnormal vital signs [Time Frame: Week 13]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 31]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 36]

CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes [Time Frame: Day 1]

CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes [Time Frame: week 25]

The ALSFRS Questionnaire [Time Frame: Day 57]

Total lymphocyte number [Time Frame: Day 57]

The ALSFRS Questionnaire [Time Frame: Week 13]

Total lymphocyte number [Time Frame: Day 64]

CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes [Time Frame: Day 64]

effector T cells: number and % of CD4 cells [Time Frame: Week 13]

Presence/absence of a clinically significant abnormality among routine laboratory tests [Time Frame: Week 25]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 57]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 63]

Phosphorylated neurofilament heavy protein (pNfH) levels in serum [Time Frame: day 1]

Presence/absence of a clinically significant abnormality among routine laboratory tests [Time Frame: Week 13]

Total lymphocyte number [Time Frame: Week 13]

Tregs (absolute number and % CF4+ cells) [Time Frame: Day 57]

Presence/absence of abnormal vital signs [Time Frame: Day 57]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 29]

Tregs (absolute number and % CF4+ cells) [Time Frame: Week 13]

Presence/absence of abnormal vital signs [Time Frame: Day 64]

Presence/absence of clinically significant abnormality on a lung x-ray [Time Frame: Baseline (day 0 to day -15)]

effector T cells: number and % of CD4 cells [Time Frame: Day 57]

effector T cells: number and % of CD4 cells [Time Frame: Day 64]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 61]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 62]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 1]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 2]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 34]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 58]

Light chain neurofilament levels in serum [Time Frame: Day 1]

Presence/absence of a clinically significant abnormality among routine laboratory tests [Time Frame: Day 1]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 59]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 60]

Presence/absence of a clinically significant abnormality among routine laboratory tests [Time Frame: Day 8]

Total lymphocyte number [Time Frame: Week 25]

Thyroid function: blood TSH [Time Frame: Week 13]

Vital capacity (% of normal) [Time Frame: Baseline (day 0 to day -15)]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 64]

The ALSFRS Questionnaire [Time Frame: Week 25]

Thyroid function: blood TSH [Time Frame: Baseline (day 0 to day -15)]

Tregs (absolute number and % CF4+ cells) [Time Frame: Day 1]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 32]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 4]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 5]

The ALSFRS Questionnaire [Time Frame: Day 29]

Thyroid function: blood T4 [Time Frame: Baseline (day 0 to day -15)]

Tregs (absolute number and % CF4+ cells) [Time Frame: Day 64]

Total lymphocyte number [Time Frame: Day 1]

Total lymphocyte number [Time Frame: Day 8]

Vital capacity (% of normal) [Time Frame: Week 25]

Light chain neurofilament levels in serum [Time Frame: Week 13]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 3]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 7]

Presence/absence of specific, pre-defined adverse events. [Time Frame: Day 8]

The ALSFRS Questionnaire [Time Frame: Day 1]

Thyroid function: blood T4 [Time Frame: Week 13]

Tregs (absolute number and % CF4+ cells) [Time Frame: Day 8]

Tregs (absolute number and % CF4+ cells) [Time Frame: Week 25]

Vital capacity (% of normal) [Time Frame: Day 1]

Vital capacity (% of normal) [Time Frame: Week 13]

Secondary ID(s)

2014-001327-71

LOCAL/2014/WC-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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