AIMSPRO in the Treatment of Bladder Dysfunction in Secondary Progressive Multiple Sclerosis (NCT01228396) | Clinical Trial Compass
UnknownPhase 2
AIMSPRO in the Treatment of Bladder Dysfunction in Secondary Progressive Multiple Sclerosis
United Kingdom20 participantsStarted 2009-05
Plain-language summary
Patients with marked bladder dysfunction as a result of secondary progressive multiple sclerosis are being recruited to receive AIMSPRO or placebo by subcutaneous injection, in this double-blind crossover study.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* M / F aged 18 years or older.
* Patients of childbearing potential must use adequate birth control measures for the duration of the study and 6 months after receiving the last injection of AIMSPRO.
* Clinically definite SPMS.
* Ambulant, walking aids allowed.
* No more than one relapse within the last 12 months and no relapse within the last 6 months.
* Urinary frequency of at least 8 times per 24-hours.
* Urinary urgency with or without urge incontinence.
* MRI brain or spinal cord abnormalities consistent with MS.
* Screening laboratory test results must meet the following criteria:
* Haemoglobin \> 9.5 g/dL
* WBC \> 3.5 x 109/L
* Neutrophils \> 1.5 x 109/L
* Platelets \> 100 x 109/L
* Baseline AST , alkaline phosphatase, Thyroid function, Serum Electrophoresis levels must be within the normal range.
* Able to adhere to the study visit schedule and other protocol requirements
* Capable of giving written informed consent.
Exclusion Criteria:
* Acute symptomatic urinary infection.
* Taking DDAVP or antimuscarinic agents.
* Full time wheelchair user.
* Immunosuppressant drug therapy of any kind in the last 3 months.
* Relapse within the last 6 months.
* No clear progression of disability in the last 12 months.
* Co-existent medical condition precluding participation, including any history of severe allergic reaction.
* Pregnant or lactating women and women who are planning pregnancy within 12 months of screening (i.e., approximately 6 months f…