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Safety and Tolerability of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures

NCT ID: NCT00151879

Last Updated: 2014-09-22

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/PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2006-05-31

Brief Summary

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Subjects enrolled in the SP615, SP756, or SP774 open-label extension (OLE) trials receiving oral SPM 927 for at least 8 weeks and a stable dose of up to 3 antiepileptic medications may participate in a research trial at approximately 30 locations.

Trial objectives include investigating whether iv SPM 927 is safe and well tolerated when given twice daily for a short period of time and identifying the appropriate infusion rate(s).

Subjects will receive SPM 927 as a 30-, 15- or 10- minute infusions twice daily for 2 - 5 days based on notification by the research doctor and subject choice. Subjects will remain on the same stable dose as received in the OLE trial.

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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Epilepsies, Partial

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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SPM 927

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Partial seizures with or without secondary generalization.

Exclusion Criteria

* Subject has previously received iv lacosamide.
* Subject meets the withdrawal criteria for the open-label extension trial.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

Locations

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Schwarz

RTP, North Carolina, United States

Site Status

Countries

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United States

References

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Krauss G, Ben-Menachem E, Mameniskiene R, Vaiciene-Magistris N, Brock M, Whitesides JG, Johnson ME; SP757 Study Group. Intravenous lacosamide as short-term replacement for oral lacosamide in partial-onset seizures. Epilepsia. 2010 Jun;51(6):951-7. doi: 10.1111/j.1528-1167.2009.02463.x. Epub 2009 Dec 22.

Reference Type RESULT
PMID: 20041945 (View on PubMed)

Other Identifiers

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2004-002322-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SP0757

Identifier Type: -

Identifier Source: org_study_id

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