EUCTR2014-001427-79-GBActive, not recruitingPhase 1
ong-term Safety and Efficacy Study of Deferiprone in Patients with Pantothenate Kinase-Associated Neurodegeneration (PKAN) - TIRCON2012V1-EXT
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ApoPharma Inc
- Enrollment
- 89
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Completed study TIRCON2012V1
- •2. Sexually active females of childbearing potential, including those who are perimenopausal (defined as less than 2 years since last menstrual period) must have a negative pregnancy test result at Visit 1 (if applicable; in cases where the investigator determines there is no reasonable risk of pregnancy because of significant incapacity, pregnancy testing will not be performed). In addition, if applicable, they must meet at least one of the following criteria:
- •? Use an effective method of contraception during the study and within 30 days following their last dose of study medication, OR
- •? Participate in a non-heterosexual lifestyle, OR
- •? Have a male sexual partner who has been sterilized (supporting evidence required)
- •Approved methods of contraception will consist of the following or must follow local requirements:
- •? Oral contraceptive used in conjunction with condom, diaphragm, or spermicide
- •? Hormonal implant used in conjunction with condom, diaphragm, or spermicide
- •? Injectable contraceptive used in conjunction with condom, diaphragm, or spermicide
- •? Diaphragm or condom used with spermicide
- •? Abstinence, which must be true abstinence that is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal,post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- •If a hormonal contraception is used, it should have a Pearl index <1%.
- •Female patients who meet any of the following criteria are not of childbearing potential and therefore do not need to practice contraception:
- •? Post-menopausal (last menstrual period > 2 years ago)
- •? Had a tubal ligation (supporting evidence required)
- •? Had a hysterectomy or oophorectomy (supporting evidence required)
- •3. Fertile heterosexual males and/or their partners must agree to use an effective method of contraception (as defined in criterion # 2) during the study and for 30 days following the last dose of study medication
- •4. Patients and/or their authorized legal representatives must provide signed and dated written informed consent prior to the first study intervention, and patients must be able to adhere to study restrictions, appointments, and evaluation schedules. Patients who are minors must sign an assent form as per local regulatory requirements.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
- •1. Withdrew from the study TIRCON2012V1 for reasons of safety
- •2. Plan to participate in another clinical trial at any time from the day of enrolment until 30 days post-treatment in the current study
- •3. Presence of any medical, psychological, or psychiatric condition which in the opinion of the investigator would cause participation in the study to be unwise.
- •4. Pregnant, breastfeeding, or planning to become pregnant during the study period.
Investigators
Similar Trials
Active, not recruiting
Phase 1
An 18-month extension of an international trial of deferiprone in patients with iron storage brain disordersEUCTR2014-001427-79-DEApoPharma Inc.90
Active, not recruiting
Phase 1
An 18-month extension of an international trial of deferiprone in patients with iron storage brain disordersPantothenate Kinase-Associated Neurodegeneration (PKAN)MedDRA version: 21.1Level: PTClassification code 10053643Term: Neurodegenerative disorderSystem Organ Class: 10029205 - Nervous system disordersEUCTR2014-001427-79-ITAPOTEX EUROPE B.V.68
Completed
Phase 2
Deferiprone for the Treatment of Parkinson’s DiseaseEarly-stage Parkinson’s diseaseNeurological - Parkinson's diseaseACTRN12617001578392ApoPharma Inc.36
Recruiting
Phase 3
Effect of Deferiprone on the improvement of symptoms of Coronavirus 2019 (COVID 19)Patients with Covid 19.Covid 19U07.01IRCT20180114038350N3Sanandaj University of Medical Sciences80
Active, not recruiting
Phase 1
A study of the benefit and safety of using the drug Deferasirox in patients with increased iron levels who have Myelodysplastic SyndromesIron overload in patients being treated for Myelodysplastic syndroms (MDS) by regular blood transfusionsMedDRA version: 14.1 Level: LLT Classification code 10068361 Term: MDS System Organ Class: 100000004864MedDRA version: 14.1 Level: LLT Classification code 10040310 Term: Serum iron increased System Organ Class: 100000004848EUCTR2011-004559-38-GBniversity of Birmingham13