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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-04

Study Completion Date

2004-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

iv SPM 927 and oral placebo tablet

Intervention Type DRUG

60-minute infusion iv SPM 927 and oral placebo tablet

2

Group Type PLACEBO_COMPARATOR

oral SPM 927 tablet and iv placebo

Intervention Type DRUG

60-minute infusion placebo and oral SPM 927 tablet

3

Group Type EXPERIMENTAL

iv SPM 927 and oral placebo tablet

Intervention Type DRUG

30-minute infusion iv SPM 927 and oral placebo tablet

4

Group Type PLACEBO_COMPARATOR

oral SPM 927 tablet and iv placebo

Intervention Type DRUG

30-minute infusion placebo and oral SPM 927 tablet

Interventions

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iv SPM 927 and oral placebo tablet

60-minute infusion iv SPM 927 and oral placebo tablet

Intervention Type DRUG

oral SPM 927 tablet and iv placebo

60-minute infusion placebo and oral SPM 927 tablet

Intervention Type DRUG

iv SPM 927 and oral placebo tablet

30-minute infusion iv SPM 927 and oral placebo tablet

Intervention Type DRUG

oral SPM 927 tablet and iv placebo

30-minute infusion placebo and oral SPM 927 tablet

Intervention Type DRUG

Other Intervention Names

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Lacosamide Vimpat Lacosamide Vimpat Lacosamide Vimpat Lacosamide Vimpat

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No