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

Epilepsy Clinical Trial

Official title:

A Multicenter, Double-blind, Double-dummy, Randomized Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures With or Without Secondary Generalization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800215
• Other study ID #: SP616
• Status: Completed
• Phase: Phase 2
• Start date: March 4, 2004
• Est. completion date: November 30, 2004

Study information

• Verified date: April 2024
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2004
• Est. primary completion date: August 17, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• iv SPM 927 and oral placebo tablet
60-minute infusion iv SPM 927 and oral placebo tablet
• oral SPM 927 tablet and iv placebo
60-minute infusion placebo and oral SPM 927 tablet
• iv SPM 927 and oral placebo tablet
30-minute infusion iv SPM 927 and oral placebo tablet
• oral SPM 927 tablet and iv placebo
30-minute infusion placebo and oral SPM 927 tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

References & Publications (1)

Biton V, Rosenfeld WE, Whitesides J, Fountain NB, Vaiciene N, Rudd GD. Intravenous lacosamide as replacement for oral lacosamide in patients with partial-onset seizures. Epilepsia. 2008 Mar;49(3):418-24. doi: 10.1111/j.1528-1167.2007.01317.x. Epub 2007 Se — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination		2 Days
Secondary	Seizure counts		2 days

External Links

•   Clinical Study Summary on UCB.com