BridgeMD
An open-label extension study evaluating the safety of zagociguat in participants with MELAS who completed TIS6463-203
EU CTIS ID: 2024-517514-15-00
What this study is testing
Primary Safety: To evaluate the long-term safety and tolerability of zagociguat
- Therapeutic exploratory (Phase II)
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
- Signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form (ICF) before any study-specific procedures are performed.
- Completed TIS6463-203 treatment through the Period 2 Week 12 visit
- If female, meets 1 of the 2 following criteria: a. Confirmed as being postmenopausal (no menses for ≥1 year or ≥12 consecutive months) or surgically sterile (bilateral oophorectomy, hysterectomy, or tubal sterilization [tie, clip, band, or burn]) OR b. If of reproductive potential: • Is not pregnant at the time of the Screening Visit and • Has negative pregnancy test results at the Screening Visit
- Male and female participants of reproductive potential must agree to use 1 of the following highly effective contraception methods (a or b) from the date of signing the ICF until ≥90 days after receiving their final study drug dose: a. Completely abstain from heterosexual intercourse OR b. If heterosexually active, adhere to ≥1 of the following: • Use a combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, OR intrauterine hormone-releasing system • Have had a bilateral tubal occlusion • Maintain a monogamous relationship with a partner who is permanently sterilized either by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis), hysterectomy, bilateral salpingectomy, or bilateral oophorectomy or is sterile due to postmenopausal status.
- Female participants on hormone replacement therapy must use ≥1 nonhormonal highly effective contraception methods listed above
- Male participants must agree to refrain from donating sperm from the Screening Visit through 90 days after their final dose of study drug
You likely can't join if
- Participants must NOT meet the following exclusion criteria on Day −1 to be enrolled: Met any individual stopping criteria (see Section 5.4.2) while participating in lead-in study TIS6463-203
- On a reduced dose at the Week 12 visit in either period of lead-in study TIS6463-203
- Experience a suspected unexpected serious adverse reaction (SUSAR) in lead-in study TIS6463-203
- Any medical condition or clinical finding that, per investigator judgement, would preclude safe study participation and/or completion of all trial requirements
See the full eligibility criteria
Who can join
- Signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form (ICF) before any study-specific procedures are performed.
- Completed TIS6463-203 treatment through the Period 2 Week 12 visit
- If female, meets 1 of the 2 following criteria: a. Confirmed as being postmenopausal (no menses for ≥1 year or ≥12 consecutive months) or surgically sterile (bilateral oophorectomy, hysterectomy, or tubal sterilization [tie, clip, band, or burn]) OR b. If of reproductive potential: • Is not pregnant at the time of the Screening Visit and • Has negative pregnancy test results at the Screening Visit
- Male and female participants of reproductive potential must agree to use 1 of the following highly effective contraception methods (a or b) from the date of signing the ICF until ≥90 days after receiving their final study drug dose: a. Completely abstain from heterosexual intercourse OR b. If heterosexually active, adhere to ≥1 of the following: • Use a combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, OR intrauterine hormone-releasing system • Have had a bilateral tubal occlusion • Maintain a monogamous relationship with a partner who is permanently sterilized either by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis), hysterectomy, bilateral salpingectomy, or bilateral oophorectomy or is sterile due to postmenopausal status.
- Female participants on hormone replacement therapy must use ≥1 nonhormonal highly effective contraception methods listed above
- Male participants must agree to refrain from donating sperm from the Screening Visit through 90 days after their final dose of study drug
- Female participants must agree to refrain from egg donation through 30 days after the final dose of study drug
What rules you out
- Participants must NOT meet the following exclusion criteria on Day −1 to be enrolled: Met any individual stopping criteria (see Section 5.4.2) while participating in lead-in study TIS6463-203
- On a reduced dose at the Week 12 visit in either period of lead-in study TIS6463-203
- Experience a suspected unexpected serious adverse reaction (SUSAR) in lead-in study TIS6463-203
- Any medical condition or clinical finding that, per investigator judgement, would preclude safe study participation and/or completion of all trial requirements
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
- Canada
- Australia
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom; Canada; Australia. 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.