EUCTR2004-002322-22-CZ
Active, not recruiting
Phase 1
A multi-center, open-label trial to investigate the safety and tolerability of intravenous SPM 927 as replacement for oral SPM 927 in subjects with partial seizures with or without secondary generalization
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- SCHWARZ BIOSCIENCES, Inc.
- Enrollment
- 160
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his informed consent.
- •2\. Subject has, in the opinion of the investigator, adequate seizure control for participation in the trial, and is willing and able to comply with all trial requirements including hospitalization, multiple blood draws and intravenous infusions.
- •3\. Subject is currently enrolled in an open\-label extension trial receiving oral SPM 927 for the treatment of partial seizures and has been enrolled for at least 8 weeks.
- •4\. Subject has been on the stable bid dosage regimen betwen 200 mg/day and 600 mg/day SPM 927, inclusive, for the last two weeks.
- •5\. Subject has been on a stable bid dosage regimen between of 700 or 800 mg/day SPM 927 for the last two weeks. Applicable only if doses above 600 mg/day are allowed.
- •6\. Subject has been on a stable dose of concomitant AED(s) for the last two weeks.
- •7\. Subject has had stable VNS settings for the last two weeks, if applicable SPM 927
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •1\. Subject is receiving any investigational drugs or using any experimental devices other than SPM 927\.
- •2\. Subject has previously received iv SPM 927\.
- •3\. Subject meets the withdrawal criteria for the open\-label extension trial.
- •4\. Subject has any medical or psychiatric condition that, in the opinion of the investigator, would compromise the subject's eligibility to participate in this trial or possibly confound interpretation of the data.
- •5\. Subject has diastolic blood pressure less than 50 mmHg or greater then 105 mmHg or heart rate less than 50 beats per minute (bpm) or greater than 110 bpm, measured in a supine position after 3 minutes at rest.
- •6\. Subject has a history of any kind of status epilepticus within the 12\-month period prior to trial entry.
- •7\. Subject has confirmed clinically relevant abnormality by ECG
Outcomes
Primary Outcomes
Not specified
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