A PHASE 2, PROSPECTIVE, INTERVENTIONAL, OPEN-LABEL, MULTI-SITE, EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND TOLERABILITY OF TAK-935 AS ADJUNCTIVE THERAPY IN PATIENTS WITH RARE EPILEPSY
- Conditions
- developmental and epileptic encephalopathiesTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-002485-39-ES
- Lead Sponsor
- Ovid Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 176
1) Patients must have participated in a previous TAK-935 study and meet one of the following conditions:
? Successfully completed a TAK-935 clinical study.
? Received at least 10 weeks of treatment (combined dose optimization and maintenance period) with the study
drug in a TAK-935 clinical study and the patient did not have a serious or severe AE that, in the
investigator’s or Sponsor's opinion, was related to the study drug and would make it unsafe for the patient to
continue receiving the study drug.
2) In the opinion of the investigator, the patient has the potential to benefit from the administration of TAK-
935.
3) The patient provides written informed consent, or the patient’s legal representative (parent or legal guardian) provides written
informed consent and the patient provides assent, before any study procedures are performed.
4) The patient and legal representative (parent or guardian) are willing to comply with all study requirements.
5) Sexually active female patients of childbearing potential (defined as first menarche) must agree to use a
highly effective method of birth control during the study and for 30 days following the last dose of study. Highly effective contraceptive methods are as follows:
a) Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of
ovulation:
? Oral
? Intravaginal
? Transdermal
b) Progestogen-only hormonal contraception associated with inhibition of ovulation:
? Oral
? Injectable
? Implantable
c) Intrauterine device
d) Intrauterine hormone-releasing system
e) Bilateral tubal occlusion
f) Vasectomized partner
g) Sexual abstinence
Sexually active male patients (post-pubertal unless permanently sterilized by bilateral orchidectomy) must
agree to use male contraception (condom) during the study and for a minimum of 90 days following the
last dose of study drug. Male patients must also not donate sperm during the Screening and Treatment
Periods and for at least 90 days after the last dose of study drug.
Are the trial subjects under 18? yes
Number of subjects for this age range: 165
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 11
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Clinically significant disease, that, in the investigator’s opinion, precludes study participation
2. 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)
3. Patient is currently pregnant or breastfeeding or is planning to become pregnant during the study or
within 90 days of the last study drug administration
4. 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method