A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis - NCT00914290-78681 (Clinical Trial 296629)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy296629.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Round Rock |
|
State:
|
|
TX |
| Zip Code: |
|
78681 |
| Conditions: |
|
Spasticity - Multiple Sclerosis |
| Purpose: |
|
To explore the safety and efficacy of IPX056 compared with baclofen tablets for alleviation
of symptoms of spasticity associated with multiple sclerosis (MS).
|
| Study summary: |
|
|
| Criteria: |
|
Inclusion Criteria:
- Male or female at least 18 years old.
- Agrees to use a medically acceptable method of contraception throughout the study
- Diagnosed with MS as defined by Poser or McDonald Criteria.
- Receiving commercial baclofen tablets at a stable total daily dose ranging from 15 mg
to 80 mg in a TID dosing regimen for at least 4 weeks prior to the Screening Visit
that has resulted in improved spasticity.
- Willing to wash out and remain off other antispasticity medications during the study.
Exclusion Criteria:
- If female, the subject is pregnant, planning to become pregnant, or breastfeeding.
- History of allergy or severe intolerance to baclofen.
- Did not respond to previous baclofen treatment in any formulation.
- Has experienced an exacerbation of MS within 1 month.
- Urinary tract infection (UTI) within 2 weeks or two symptomatic UTIs within 6 months
prior to the study.
- Subjects with clinically significant impairment of renal function
- History of active seizure disorder or epilepsy, or currently taking an anticonvulsant
for treatment or control of seizure.
- Other conditions causing spasticity (e.g., stroke, cerebral palsy, traumatic brain
injury) or rigidity (e.g. Parkinson's Disease).
- Treated with Botulinum Toxin Type A or B within the previous 4 months, or with phenol
or therapeutic alcohol nerve block within 12 months or planned use of these drugs
during this study.
- Has clinically significant limitation of passive range of motion of lower
extremities.
- Has had major surgery within 6 months prior to Screening Visit that may affect
spasticity assessments such as abdominal surgery, back surgery, lower leg and knee
surgeries. |
|
|
|
| Study is available at: |
|
Central Texas Neurology Consultants
Round Rock, TX 78681
United States
Primary Contact:
IPX056-B09-01 Study Coordinator
Phone: 512-218-1222 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 16, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|