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Synergy (Lingo-1) Clinical Trial

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Phoenix Neurological Associates, Ltd.
5090 N 40th St # 250
Phoenix, AZ 85018
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® (215MS201, SYNERGY)

Description:
LINGO (BIIB033) is a human monoclonal antibody directed against LINGO-1, with potential to enhance remyelination and neuroaxonal protection in the central nervous system (CNS).

The rationale for this study is to explore the potential efficacy of BIIB033 on enhancing CNS repair through remyelination and neuroaxonal protection in MS, while treating the inflammatory aspect of the disease with an approved immunomodulatory agent, Avonex®.
BIIB033 or placebo will be administered intravenously every 4 weeks for 19 visits. Study duration will be 22 months. In addition to BIIB033 or placebo, all participants will receive Avonex® (interferon beta-1a weekly intramuscular injections).

People eligible for participation include:
1. Age 18 – 58.
2. Diagnosis or Relapsing Multiple Sclerosis. Can be newly diagnosed or previously diagnosed.
3. A clinical relapse in the past 12 months with either a Gadolinium-enhancing lesion or new T2 lesion by brain or spine MRI.
4. Baseline EDSS 2.0 – 6.0 (Minimal disability through ambulates with cane).
5. No prior treatment failure with any injectable interferon defined by 2 or more relapses or new lesions over a 12 month period while adherent to therapy.
6. Those treated with fingolimod (Gilenya®) or natalizumab (Tysabri®) will need a 3 month wash-out prior to their baseline visit.
6. For female participants, no desire for pregnancy during the study and use of reliable contraception for 6 months after their last dose of study medication.
7. No history of seizures, malignancy, or suicidality. No severe cardiac, liver, kidney, or lung disease.
8. Willingness to come to appointments every 4 weeks. No contra-indications to frequent brain MRI scans.

Length of Trial:
The trial will be 22 months, including 1 month for screening, a treatment period of 18 months, and a follow-up period of 3 months. Subjects will come to the medical center each month for 19 months for infusions, clinical assessments, and MRI scans.

Clinical Trial Sponsor:
Biogen Idec

Who is the Principal Investigator (Doctor):
Dr. Barry A Hendin
5090 N 40th St # 250,
Phoenix, AZ 85018

Contact:
Lynne E. Flynn, CCRC, study coordinator
602-258-2863 or lynneflynn@pnal.net
or call the main line at 602-258-3354

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