EUCTR2018-000160-28-ITActive, not recruitingPhase 1
ong term safety study of amifampridine phosphate in ambulatory patients with Spinal Muscular Atrophy (SMA) type 3 - SMA-002
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Patients participated in the SMA-001 study
- •- Willing and able to provide written informed consent after the nature of the study has been explained and before the start of any research-related procedures
- •- Female patients of childbearing potential defined according to the Clinical Trial Facilitation Group - CTFG guidelines* must have a negative pregnancy test (urine human chorionic gonadotropin [HCG] at the end of SMA-001 study) and must practice an effective, reliable contraceptive regimen during the study and for up to 30 days following discontinuation of treatment
- •- Ability to participate in the study based on overall health of the patient and disease prognosis, as applicable, in the opinion of the Investigator; and able to comply with all requirements of the protocol, including completion of study questionnaires.
- •* According to CTFG guidelines a woman is considered of childbearing potential, i.e. fertile,
- •following menarche and until becoming post-menopausal unless permanently sterile.
- •Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral
- •oophorectomy. A postmenopausal state is defined as no menses for 12 months without an
- •alternative medical cause.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •- Epilepsy and currently on medication
- •- Uncontrolled asthma
- •- Concomitant use with sultopride
- •- Concomitant use with medicinal products with a narrow therapeutic window
- •- Concomitant use with medicinal products with a known to cause QTc prolongation
- •- Clinically significant abnormalities in 12 lead ECG, in the opinion of the Investigator
- •- Subjects with congenital QT syndromes
- •- Breastfeeding or pregnant at Screening or planning to become pregnant at any time during the study
- •- Intolerable amifampridine-related side effects
- •- Treatment with an investigational drug (other than amifampridine) or device while participating in this study
- •- Any medical condition that, in the opinion of the Investigator, might interfere with the patient’s participation in the study, poses an added risk for the patient, or confound the assessment of the patient
- •- History of drug allergy to any pyridine-containing substances or any amifampridine excipient(s)
Investigators
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