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

UCB Pharma60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Epilepsy

Interventions

iv SPM 927 and oral placebo tabletDRUG

60-minute infusion iv SPM 927 and oral placebo tablet

oral SPM 927 tablet and iv placeboDRUG

60-minute infusion placebo and oral SPM 927 tablet

iv SPM 927 and oral placebo tabletDRUG

30-minute infusion iv SPM 927 and oral placebo tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 2 Days

Secondary Outcomes

Seizure counts

Time frame: 2 days

Data from ClinicalTrials.gov

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