Ensayos clínicos

Inclusion Criteria:

Patients must have participated in a previous TAK-935 study and meet one of the following conditions:

• Successfully completed a TAK-935 clinical study. 
• In the opinion of the investigator, the patient has the potential to benefit from the administration of TAK-935 (not applicable for Spain).
• The patient provides written informed consent, or the patient’s legal representative (ie, parent or legal guardian) provides written informed consent and the patient provides assent, before any study procedures are performed.
• The patient and patient’s legal representative (i.e., parent or guardian [as applicable]) are willing to comply with all study requirements. 
• From signing of informed consent, throughout the duration of the study, and for 30 days after last dose of study drug, female patients of childbearing potential* who are sexually active with a non-sterilized male partner** must agree to use a highly effective method of contraception (from the list below). In addition, they must not donate ova during this period.  

* Females NOT of childbearing potential are defined as those who are prior to first menarche or who have been surgically sterilized (hysterectomy, bilateral oophorectomy, or tubal ligation) or who are postmenopausal (e.g., defined as ≥ 1 year since last regular menses with a follicle stimulating hormone level > 40 IU/L or ≥ 5 years since last regular menses, confirmed before any study drug is administered).

**Sterilized males should be ≥ 1 year post-vasectomy and have confirmed that they have obtained documentation of the absence of sperm in the ejaculate.

A highly effective method of contraception is defined as one that has no higher than a 1% failure rate per year when used consistently and correctly. In this study, the only acceptable methods of contraception are as follows:

• 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.
• Double-barrier methods (each time the patient has intercourse):
  • Sponge (plus spermicidal cream or jelly) PLUS male condom with or without spermicidal cream or jelly;
  • Cap (plus spermicidal cream or jelly) PLUS male condom with or without spermicidal cream or jelly;
  • Diaphragm (plus spermicidal cream or jelly) PLUS male condom with or without spermicidal cream or jelly.
• Intrauterine device (Copper T PLUS condom).
• Intrauterine hormone-releasing system.
• Sterilization:
  • Bilateral tubal occlusion;
  • Vasectomized partner (provided that the partner is the sole sexual partner of the patient and the absence of sperm in the ejaculate has been confirmed).
• Sexual abstinence, if it is the preferred and usual lifestyle of the patient, will be considered an acceptable method of contraception on a case-by-case basis upon prior approval by the medical monitor. Patients practicing abstinence as a method of contraception must refrain from heterosexual intercourse throughout the duration of the study and for 30 days after last dose of study drug.

Exclusion Criteria: 

• Clinically significant disease, that, in the investigator’s opinion, precludes study participation.
• Enrollment in any other clinical trial involving an investigational drug, device, or treatment in the past 90 days (with the exception of an antecedent study involving TAK-935).
• Patient is currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration.
• Suicide attempt within the last year, at significant risk of suicide (either in the opinion of the investigator or defined as ‘yes’ to suicidal ideation question 4 or 5 on the Columbia-Suicide Severity Rating Scale [C-SSRS] at Screening) or appearing suicidal per investigator judgment.