ARPEGGIO: Laquinimod for Primary Progressive Multiple Sclerosis (PPMS)
Research type
Research Study
Full title
A Multinational, Multicenter, Randomized, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS)
IRAS ID
162372
Contact name
Sally Burtles
Contact email
Sponsor organisation
Teva Pharmaceutical Industries Ltd
Eudract number
2014-001579-30
Clinicaltrials.gov Identifier
71,287, IND number
Duration of Study in the UK
2 years, 4 months, 26 days
Research summary
More than 100,000 people in the UK have multiple sclerosis (MS). MS is a condition in which a person’s immune system attacks its own nervous system. This damage can cause a range of symptoms including vision problems, walking problems, coordination problems, bladder problems, fatigue, stiffness, pain, or effects on memory, thinking and emotions.
At diagnosis, approximately 85% of patients have relapsing remitting MS (RRMS). This is characterised by distinct attacks of symptoms which then fade away. Primary progressive MS (PPMS) where symptoms gradually get worse over time (without distinct attacks) affects approximately 15% of patients. Several treatments are available for RRMS, but have not been effective in progressive MS.
Laquinimod is being tested for RRMS. The results suggest it has a protective effect on the central nervous system and may be effective in progressive MS. The purpose of the current study is to assess the efficacy, safety and tolerability of laquinimod in PPMS.
Patients will be randomised in a 1:1:1 ratio to receive 0.6 mg laquinimod, 1.5mg laquinimod or placebo once daily. The study is split into two parts. Part A will last at least 48 weeks, depending on the order of enrollment. Visits will be performed every 4 weeks until Week 12 and then every 12 weeks. Once the last patient has completed 48 weeks, Part A will end. In Part B, patients will continue to receive their assigned treatment and have visits every 12 weeks. Study procedures include physical examination, vital signs, ECG, blood sampling, MRI scans and various MS assessments.
Once the study analysis is complete, patients may be invited to continue treatment in a separate extension study.
This study is sponsored by TEVA Pharmaceutical Industries Ltd. Approximately 375 patients will participate in this study worldwide with 33 patients from 10 hospitals in the UK.
REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/1837
Date of REC Opinion
27 Nov 2014
REC opinion
Further Information Favourable Opinion