BridgeMD
A Study Providing Continued Access to Treatment in Patients with a Neurological Disease Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study and without Access to A Post Trial Access Program
EU CTIS ID: 2023-507633-21-00
What this study is testing
To provide continued treatment with Roche IMP(s)-based therapy for eligible patients with a neurological disease still on study treatment at the time of roll-over from the parent study who do not have reasonable access to the study treatment locally.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Signed extension study Informed Consent Form
- 2. Eligible for continuing on Roche IMP-based therapy at the time of roll-over from the parent study, as per the parent study protocol
- 3. First dose of study treatment in this extension study will be received within the treatment window allowed by the parent study.
- 4. Continue to benefit from the Roche active substance at the time of roll-over from the parent study as assessed by the investigator
- 5. Ability to comply with the extension study protocol, per investigator’s judgement
- 6. Negative urine pregnancy test within 24 hours to first dose administered on MN45053 study treatment in women of childbearing potential
You likely can't join if
- 1. Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study
- 2. Study treatment is commercially marketed in the patient’s country for the patient-specific disease and is reasonably accessible to the patient
- 3. Study treatment is available via Post Trial Access Program (PTAP) in the patient’s country and is accessible to the patient
- 4. Treatment with any other neurological treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this extension study
- 5. Permanent discontinuation of study treatment for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable)
- 6. Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.