A double-blind, placebo-controlled, randomised trial to prove the therapeutic concept and to determine the pharmacokinetic profile of ATL 1102 (VLA-4 antisense oligonucleotide) by subcutaneous injections in patients with multiple sclerosis.

Phase 1

• Conditions: To evaluate the efficacy of a selected treatment regimen of ATL 1102 in patients with Relapsing Remitting MS (RRMS) inflammatory lesions using MRI with gadolinium administration compared to placebo.

• Registration Number: EUCTR2006-004736-79-SK
• Lead Sponsor: Antisense Therapeutics Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-17
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

•Males and females aged 18 - 55 years
•Diagnosis: Multiple Sclerosis” Relapsing Remitting MS (RRMS)
•At least 9 T2 lesions or at least 4 if one is gadolinium-enhancing
•Last relapse in the previous 12 months
•No relapse in the previous four weeks
•Score of EDSS 0.0 – 6.0
•Reliable contraception (e.g. surgical sterilisation, oral contraceptives)
•Written informed consent to participate in the study by signature on the Patients Consent Form.

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Administration of any investigational drug within the previous 2 months before enrolment (4 months if the previous drug was a new chemical entity)
•Progressive disease
•Concomitant clinically relevant other findings on MRI that may interfere with outcome assessment
•Previous treatment with VLA-4 antibodies, anti-CD4 antibodies, or other monoclonal antibodies
•Total lymphoid irradiation at any time
•Treatment with immune-modulating drugs in the previous two months or treatment with immune-suppresive drugs in the previous six months
•HIV positive patients
•Detectable levels of JC Virus in the blood measured by Quantitative PCR
•Patients with renal impairment with serum creatinine ? 2,0 mg/dl
•History of clinically relevant gastrointestinal, hepatic, renal, endocrine, haematological, metabolic, neurologic (other than MS) and psychiatric disease
•Patients with infections (lymphocytes > 3000/µL)
•History of any bleeding
•History of coagulation abnormalities
•Concomitant medication acetyl salicylic acid (> 300 mg/day) and phenprocoumon
•Clinically relevant abnormalities in physical findings at screening examination if interfering with the study objective
•Pregnant or breast-feeding women
•History of drug or alcohol abuse
•Epileptics
•Suicidal subjects
•History of drug allergy and/or known drug hypersensitivity
•Inability to communicate or cooperate with the Investigator due to language problem, poor mental development or impaired cerebral function
•Any medical condition which, in the judgement of the Investigator, might interfere with the objectives of the study
•Repeated participation in this study
•Contraindication for application of study drug
•Corticoid-treatment in the previous six weeks and during the study period
•Exceptions:Corticoid-treatment before the study period (not in the previous six weeks) and of relapses during the study period: Relapses are characterised by the occurrence of neurological dysfunction symptoms, appearing after a 30-day period of stability or improvement and lasting for more than 24 hours (no infection, no fever).
A 5-day methylprednisolone treatment 1000 mg i.v. is allowed in this case followed by a reducing procedure.
•Corticoid-treatment if applied locally (e.g. inhaled products) is allowed.
•Additionally MRI exclusion criteria:
-Metal residing in the body (e.g. implants)
-Cardiac pacemaker, valves, cochlear implants, CNS vascular clips
-Contrast medium allergy (Gd-DTPA)

Study & Design

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