Clinical Trial Details

Study to Assess the Efficacy and Safety of Tecfidera in Patients with Amyotrophic Lateral Sclerosis - TEALS Study

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Trial Information

Broad Health Condition Neurological
Musculoskeletal

Specific Health ConditionNeurodegenerative diseases
Other muscular and skeletal disorders

Trial FocusTreatment

Recruitment statusNot yet recruiting

Recruitment Details
Recruitment State
NSW,QLD,SA,WA,VIC

Hospital
Westmead Hospital - Westmead
Royal Prince Alfred Hospital - Camperdown
Royal Brisbane & Womens Hospital - Herston
Calvary Health Care Bethlehem Ltd - Caulfield
Flinders Medical Centre - Bedford Park
Fiona Stanley Hospital - Murdoch


Postcode
2145 - Westmead
2050 - Camperdown
4029 - Herston
3162 - Caulfield
5042 - Bedford Park
6150 - Murdoch

Anticipated date of first participant enrolment18/04/2018

Anticipated date of last participant enrolment18/04/2018

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Trial summary

The primary purpose of this study is to assess whether dimethyl fumarate will slow down disease progression in sporadic ALS.  The study hypothesis is based on findings that the regulatory T cells, which form an important component of the immune system, slow down disease progression in ALS.  increasing the levels and function of regulatory T cells could slow down disease progression in ALS.  Dimethyl fumarate effectively increases the function of regulatory T cells and it is hoped that this increase in T cell function will significantly slow disease progression in ALS when compared to conventional treatment.  
Eligibility

Key inclusion criteria

1.	Male and female patients aged 18 to 85 years at the time of the Screening Visit.
2.	Able to provide informed consent and comply with study procedures.
3.	Sporadic ALS diagnosed as definite, probable, or possible according to the Awaji criteria as determined by a neurologist subspecializing in ALS.
4.	Disease duration at recruitment less than 24 months from diagnosis.
5.	Patient must have the results of magnetic resonance imaging scan of brain and spinal cord undergone within 2 years (24 months) prior to the Screening Visit.
6.	Forced vital capacity >60% of predicted value as adjusted for gender, height, and age at the Screening Visit.
7.	Must be on a stable dose of riluzole for at least 30 days prior to the Screening Visit.
8.	Patient who has established care with a neurologist at 1 of the 5 specialised ALS clinics involved in the study and will maintain this clinical care throughout the study.
9.	If a patient is referred from a third party (neurologist or a State based ALS organisation) they should be willing to transfer care to the neurologist participating in the study. 
10.	Patients may participate in clinical registries, but will be excluded if they are participating in a clinical study involving an alternative investigational treatment.
11.	Women of childbearing potential must have a negative urine pregnancy test at screening and Baseline, and be surgically sterile or postmenopausal, or using highly effective methods of contraception throughout the study and for 30 days after the last dose of IP.  

Minimum age18 Years

Maximum age85 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Dependence on mechanical ventilation at the time of screening.
2.	Gastrostomy at the time of Screening/Baseline Visit.  If the patient has a gastrostomy tube inserted post randomisation they will be allowed to continue in the study.
3.	Participation in any other IP study or using an IP (within 12 weeks prior to screening).
4.	Known hypersensitivity to Tecfidera or any excipients in this product.
5.	Presence of a monogenic cause of ALS (e.g. known mutation in superoxide dismutase-1 (SOD1), expansion in c9orf72 etc.).
6.	Taking immunosuppressive medications. 
7.	Positive test for human immunodeficiency virus (HIV), hepatitis B (+HbsAg), or hepatitis C.
8.	Presence of any of the following clinical conditions at the time of screening:
-Unstable medical disease (such as unstable angina, heart failure, chronic obstructive pulmonary disease, liver disease or renal disease), or active infectious diseases (such as hepatitis B or C or tuberculosis), or current malignancy.
-Unstable psychiatric illness defined as psychosis or untreated major depression within 90 days of the Screening Visit.  This exclusion criteria is based on a prior psychiatric diagnosis that is unstable as determined by the patient’s treating Psychiatrist.
-Dementia as previously diagnosed by a medical practitioner.

9.	Safety Laboratory Criteria at the Screening Visit:
 -Alanine aminotransferase >3 × the upper limit of normal (ULN).
 -Total bilirubin, lactate, triglycerides, amylase, or lipase >2 × the ULN.
 -Patient has impaired renal function defined as creatinine clearance of <40 mL/min via  Cockroft Gault method.
-Absolute neutrophil count of <2 × 109/L.
-Absolute lymphocyte count of <0.5 × 109/L. 
-Platelet concentration of <100 × 109/L.
-Haemoglobin <100 g/L.

10.	Female patients who are pregnant or lactating, or intend to become pregnant during the study period.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of Sydney
Primary Sponsor Address: Camperdown NSW 2006
Primary Sponsor Country: Australia

Trial websiteNil

Trial IDACTRN12618000534280

UTN U1111-1211-7805

Contact person for information and recruitmentProf
Steve Vucic
Department of Neurology Westmead Hospital Cnr Hawkesbury and Darcy Roads Westmead NSW 2145
+61298456097

Further information iconsteve.vucic@sydney.edu.au
Australia