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

Primary Purpose

Relapsing-Remitting Multiple Sclerosis

Status
Unknown status
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
lamotrigine
Sponsored by
Cantonal Hospital of St. Gallen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis focused on measuring neuroprotection, multiple sclerosis, brain atrophy, mr-spectroscopy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cantonal Hospital St. GallenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

lamotrigine

Placebo

Arm Description

7 weeks initial phase with increasing dose beginning with 25 mg oral 12 months treatment phase with fixed dose of 100 mg oral

300mg Mannitol with 2% Aerosil

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

relapse rate
Expanded disability status score
Fatigue Severity Score
N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy

Full Information

First Posted
June 9, 2009
Last Updated
June 9, 2009
Sponsor
Cantonal Hospital of St. Gallen
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1. Study Identification

Unique Protocol Identification Number
NCT00917839
Brief Title
The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis
Official Title
Randomized, Placebo-Controlled Phase II Monocentric Trial for the Neuroprotective Effect of Lamotrigine Plus Interferon Beta 1a 30mcg Once Weekly Intramuscular in Patients With Relapsing-Remitting Multiple Sclerosis.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Cantonal Hospital of St. Gallen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-Remitting Multiple Sclerosis
Keywords
neuroprotection, multiple sclerosis, brain atrophy, mr-spectroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lamotrigine
Arm Type
Experimental
Arm Description
7 weeks initial phase with increasing dose beginning with 25 mg oral 12 months treatment phase with fixed dose of 100 mg oral
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
300mg Mannitol with 2% Aerosil
Intervention Type
Drug
Intervention Name(s)
lamotrigine
Intervention Description
100 mg, once daily, 12 months
Primary Outcome Measure Information:
Title
N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy
Time Frame
12 months
Title
Safety of lamotrigine in combination with interferon beta 1a (30 mcg) once weekly intramuscular.
Time Frame
6 months, 12 months
Secondary Outcome Measure Information:
Title
relapse rate
Time Frame
12 months
Title
Expanded disability status score
Time Frame
12 months
Title
Fatigue Severity Score
Time Frame
12 months
Title
N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Norman Putzki, MD
Phone
+4171494
Ext
1663
Email
norman.putzki@kssg.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Ozgur Yaldizli, MD
Phone
+4171494
Ext
3587
Email
oezguer.yaldizli@kssg.ch
Facility Information:
Facility Name
Cantonal Hospital St. Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norman Putzki, MD
Phone
+4171494
Ext
1663
Email
norman.putzki@kssg.ch
First Name & Middle Initial & Last Name & Degree
Norman Putzki, MD
First Name & Middle Initial & Last Name & Degree
Ozgur Yaldizli, MD

12. IPD Sharing Statement

Learn more about this trial

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

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