The Neuroprotective Effect of Lamotrigine and Interferon... | NCT00917839

Studies
The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis

NCT00917839

Sponsor

Cantonal Hospital of St. Gallen

Status

Unknown status

Last Update Posted

Jun 10, 2009Estimated

Enrollment

88Estimated

Phase

Phase 2

Conditions

Relapsing-Remitting Multiple Sclerosis

Interventions

lamotrigine

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Jun 9, 2009

First Submission Date that Met QC Criteria

Jun 9, 2009

First Posted Date

Jun 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2009

Last Update Posted Date

Jun 10, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is designed to evaluate the neuroprotective effect of lamotrigine in the combination of interferon beta 1a once weekly intramuscular in patients with relapsing-remitting multiple sclerosis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lamotrigine	Experimental	7 weeks initial phase with increasing dose beginning with 25 mg oral 12 months treatment phase with fixed dose of 100 mg oral	Drug: lamotrigine
Placebo	Placebo Comparator	300mg Mannitol with 2% Aerosil	Drug: lamotrigine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lamotrigine	Drug	100 mg, once daily, 12 months	Placebo lamotrigine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy		12 months
Safety of lamotrigine in combination with interferon beta 1a (30 mcg) once weekly intramuscular.		6 months, 12 months

Secondary Outcomes

Measure	Description	Time Frame
relapse rate		12 months
Expanded disability status score		12 months
Fatigue Severity Score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

definitive multiple sclerosis according to Mc Donald criteria
clinical isolated syndrome according to Mc Donald criteria
Expanded Disability Status Scale Score 0-5
Pre-treatment with interferon beta 1a (Avonex) since at least 2 months before inclusion

Exclusion Criteria:

relapse within 30 days prior to randomisation
steroid pulse therapy within 30 days prior to randomisation
pregnancy or poor contraception
contraindication for lamotrigine
depressive symptoms
drugs with possible interaction with lamotrigine according to instruction leaflet
other medical relevant conditions but multiple sclerosis
clinically relevant laboratory results
contraindication for MRI
missing informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Norman Putzki, MD	Contact	+4171494	1663	norman.putzki@kssg.ch
Ozgur Yaldizli, MD	Contact	+4171494	3587	oezguer.yaldizli@kssg.ch

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cantonal Hospital St. Gallen	Recruiting	Sankt Gallen	Canton of St. Gallen	9007	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D020529	Multiple Sclerosis, Relapsing-Remitting
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077213	Lamotrigine

Ancestor Terms

ID	Term
D014227	Triazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided