This clinical study compares the effectiveness of two anticonvulsants Lamotrigine (Lamictal)
Monotherapy and Gabapentin (Neurontin) in patients with treatment resistant affective
disorders. We initially have found that the response rate to lamotrigine (51%) exceeded that
of gabapentin (28%) or placebo (21%). In this study the placebo phase has been dropped so
that we examine possible clinical and biological factors predictors of response. The drugs
will be given in a randomized order for six weeks each and you will not know when you are on
a given one. There will be a 2-4 week "washout" period between treatments. If you respond
well to one of these treatments, a longer open continuation period will be offered at the end
of this study. This would involve one or both drugs in combination. A variety of rating
scales and brain imaging procedures will also be offered before and during each drug
evaluation. Both lamotrigine and gabapentin are generally well tolerated. A serious
potentially life threatening rash occurs in about 1/500 patients treated with lamotrigine,
however. Common side effects are rash, dizziness, unsteadiness, double vision, blurred
vision, nausea, vomiting, insomnia, sedation, and headache. These side effects are usually
mild, and resolve with continued time on the drug or a decrease in dosage.
This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to
the current therapy of pediatric patients age 1-24 months old with partial seizures. The
medication used in this study has been approved by FDA for the adjunctive treatment of
partial seizures in patients 2 years and older.
This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with
partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age
who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will
be added to the subject's current epilepsy medications.
Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.