Safety and Efficacy of Apovir for treatment of patients with ALS (Amyotrophic lateral sclerosis)

Phase 1

• Conditions: Amyotrophic Lateral Sclerosis (ALS); MedDRA version: 17.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-002099-15-SE
• Lead Sponsor: Apodemus AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-01
• Last Update Posted: 12 September 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female study subjects fulfilling the probable or higher criteria for ALS according to the revised El-Escorial criteria
2. First documented symptom of ALS = 24 months before screening
3. The sum of the 3 respiratory items on the ALSFRS-R, 10: dyspnoea, 11: orthopnoea and 12: respiratory insufficiency, must total at least 10 points
4. Ability to walk without other walking aids than a crutch
5. 18 – 80 years at the time of screening
6. FEV% =70%
7. Study subjects with or without pharmacological treatment, i.e. Riluzole for ALS (study subjects with ongoing pharmacological treatment for ALS shall have received unchanged treatment as regards drug(s) and dose(s) for at least 1 month)

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Women in fertile age with a positive pregnancy blood test, or planning to become pregnant during the period of the trial. Fertile women include any female who has experienced menarche, who has not undergone tubal ligation, and who is not postmenopausal. Postmenopausal is defined as amenorrhea = 12 consecutive months without another cause
2. Sexually active men and women without highly effective contraceptive treatment, e.g. sterilisation, condoms and diaphragms with spermicide; oral contraceptives (including Progesterone-only pills in high dose) in combination with a barrier method; hormonal contraceptives alone are not sufficient
3. Active hepatitis B, active hepatitis C, or HIV infection
4. Serious cardiac disease including unstable or uncontrolled cardiac disease during the last 6 months and/or a previous history or present clinical signs of deep venous thrombosis
5. Major surgical procedure within 4 weeks prior to start of treatment
6. Participation in any other clinical trial within 30 days of inclusion (randomisation) in the trial or patients with unresolved investigational treatment-related adverse events
7. Other chronic disease or previous organ transplantation judged by the Investigator to interfere with the assessment of treatment success and/or ability to fully participate in the trial
8. Impaired kidney function with an absolute GFR calculated from cystatin C <60 mL/min
9. Known blood disease or Anaemia Haemoglobin <120 g/L for women and <130 g/L for men
10. Known haemoglobinopathy (e.g. thalassemia and sickle cell anaemia)
11. Patients that require immunosuppressive treatments including azathioprine, cyclosporine, systemic steroid treatment (e.g. prednisolone at doses of =10 mg/day or hydrocortisone) or has received such treatment within the last 6 months prior to randomization
12. Patients that are treated with drugs that can interact significantly with APO-P001; ethinylestradiol and/or ribavirin; azathioprine, didanosine, zidovudine, mercaptopurine, stavudine
13. Lack of suitability for participation in the trial, for any reason, as judged by the Investigator
14. Patients with clinical or other signs of frontal temporal lobe dementia (FTLD) or known heredity for FTLD

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified