Clinical trial

A Multicenter, Double-blind, Double-dummy, Randomized Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures With or Without Secondary Generalization

Name

SP616

Description

The purpose of this trial was to evaluate the safety and tolerability of SPM 927 when given as iv infusions compared with oral administration of the same dose strengths in subjects who were receiving oral SPM 927 for partial seizures with or without secondary generalization. Trial procedures will include medical history update, physical/ neurological exams, ECGs, blood /urine sample collections and seizure diary completion. Subjects completing the trial will return to the OLE trial to resume dosing with oral SPM 927.

Trial arms

Trial start

2004-03-04

Estimated PCD

2004-08-17

Trial end

2004-11-30

Status

Completed

Phase

Early phase I

Treatment

iv SPM 927 and oral placebo tablet

60-minute infusion iv SPM 927 and oral placebo tablet

Arms:

Other names:

Lacosamide, Vimpat

oral SPM 927 tablet and iv placebo

60-minute infusion placebo and oral SPM 927 tablet

Arms:

Other names:

Lacosamide, Vimpat

iv SPM 927 and oral placebo tablet

30-minute infusion iv SPM 927 and oral placebo tablet

Arms:

Other names:

Lacosamide, Vimpat

oral SPM 927 tablet and iv placebo

30-minute infusion placebo and oral SPM 927 tablet

Arms:

Other names:

Lacosamide, Vimpat

Size

Primary endpoint

Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination

2 Days

Eligibility criteria

Inclusion Criteria: * Subject with partial seizures with or without secondary generalization Exclusion Criteria: * Subject had previously received iv SPM 927 * Subject met the withdrawal criteria for the open-label extension trial with SPM 927 or was experiencing an ongoing serious adverse event.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2024-04-19

1 organization

2 products

1 indication

Organization

Product

Indication

Product