Do you manage patients with multiple system atrophy (MSA)?
Learn how you can get involved to support a nearby study that is enrolling qualified patients.
About the Research Study
TAK-341-2001 is a phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of intravenous TAK-341. There are currently no marketed or available therapies that can slow or prevent the progression of MSA. Phase 1 studies of TAK-341 have demonstrated acceptable pharmacokinetic (PK) characteristics and target engagement and no safety issues to date. This will be the first phase 2 study to test the efficacy and safety of TAK-341 in participants with MSA.
The investigational drug, TAK-341, is an α-synuclein (αSYN)–specific, fully human monoclonal antibody (formatted as an immunoglobulin G1 triple mutation) that specifically binds to the C-terminal region of human αSYN with high affinity. TAK-341 is being evaluated and developed primarily as a therapeutic antibody to delay the rate of clinical progression and the rate of cumulative disability of MSA.
The TAK-341-2001 study includes two cohorts. The Early PK Cohort will randomize the first approximately 15 eligible participants in a 2:1 ratio to receive either TAK-341 or placebo. The Main Cohort will randomize approximately 123 eligible participants in a 1:1 ratio to receive either TAK-341 or placebo.
How You Can Get Involved
As a health care provider (HCP) who manages patients with MSA, you are invited to participate in the Effectus Patient Identification and Consultation Program to help identify candidates for the TAK-341-2001 Study. You will be asked to consult with patients in a neutral manner about the study and assess their interest in participating at a nearby study site. Patients may be able to take part if they meet the following criteria:
- Male or female 40 years of age or older
- Diagnosis of possible or probable MSA
- Onset of first MSA symptoms (including parkinsonism, cerebellar symptoms, orthostatic or urinary symptoms) ≤4 years before screening
- Anticipated life expectancy ≥3 years
- Meet additional study criteria, which will be provided to you upon program training
The Effectus Patient Identification and Consultation Program
Effectus Patient Identification and Consultation Program Overview
Support Provided
Effectus will be your trusted partner throughout your participation, helping to facilitate your patients to the study site and thus relieving the burden on your practice. If you wish to participate, you will be asked to review and sign a Services Agreement with Effectus, which outlines your program responsibilities and compensation. Participation is completely voluntary, and you can opt out at any time. Background on the studies, program materials, and program logistics will be reviewed in detail during a 1-hour virtual training session.
Why You Should Participate
The TAK-341-2001 Study program, sponsored by Takeda, provides an opportunity to contribute to the research and advancement of a potential new treatment option for patients with MSA. Eligible patients may have the opportunity to access the investigational drug that may delay the rate of clinical progression and the rate of cumulative disability of MSA.
Sign a services
agreement.
Receive a package of
program materials and
complete a simple, one-hour
virtual training session.
Utilize key screening
criteria to identify
potentially eligible
patients.
If the patient meets the criteria,
conduct a neutral consultation
about the availability of the
nearby study and gauge the
patient’s interest.
If the patient is interested in
participation, our team of dedicated
Patient Facilitators help ensure a
smooth patient transfer from your
office to the study.
The patient is scheduled
and presents at the study
site for the screening
appointment.
The patient’s enrollment
status is determined and is
relayed back to the treating
HCP by Effectus.
For more information on our program, please visit https://www.effectusctr.com/physician-network/.
The Effectus Patient Identification and Consultation Program
Contact Us
Montana Markell, Project Coordinator
Phone: 703-635-8975
Email: mmarkell@effectusctr.com