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

NCT00800215 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-04-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

iv SPM 927 and oral placebo tablet

60-minute infusion iv SPM 927 and oral placebo tablet

DRUG

oral SPM 927 tablet and iv placebo

60-minute infusion placebo and oral SPM 927 tablet

DRUG

iv SPM 927 and oral placebo tablet

30-minute infusion iv SPM 927 and oral placebo tablet

DRUG

oral SPM 927 tablet and iv placebo

30-minute infusion placebo and oral SPM 927 tablet

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-04
Primary Completion
2004-08-17
Completion
2004-11-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00800215 on ClinicalTrials.gov