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

UCB

Status and phase: Completed; Phase 2

Conditions: Epilepsy

Treatments: Drug: iv SPM 927 and oral placebo tablet; Drug: oral SPM 927 tablet and iv placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00800215

SP616

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: iv SPM 927 and oral placebo tablet

Drug: iv SPM 927 and oral placebo tablet

2

Placebo Comparator group

Treatment:

Drug: oral SPM 927 tablet and iv placebo

Drug: oral SPM 927 tablet and iv placebo

3

Experimental group

Treatment:

Drug: iv SPM 927 and oral placebo tablet

Drug: iv SPM 927 and oral placebo tablet

4

Placebo Comparator group

Treatment:

Drug: oral SPM 927 tablet and iv placebo

Drug: oral SPM 927 tablet and iv placebo