CompletedPhase 2

A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927

60 participantsStarted 2004-03-04

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 2 Days

Trial details

NCT IDNCT00800215

SponsorUCB Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2004-08-17

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