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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.