A randomised, double-blind, placebo controlled study of AIMSPRO in Multiple Sclerosis - AIMSPRO in MS bladder function

Conditions

Overactive Bladder in Secondary Progressive Multiple Sclerosis and the other neurological symptoms associated with Secondary Progressive Multiple Sclerosis MedDRA version: 9.1 Level: LLT Classification code 10063400 Term: Secondary progressive multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10059617 Term: Overactive bladder MedD

Related papers

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Interventions

Product Name: AIMSPRO Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria will be eligible for study enrolment 1. Male and Female patients aged 18 years or older. a. Men and women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last injection of AIMSPRO. 2. Have clinically definite SPMS. 3. Be ambulant, walking aids allowed. 4. Have had no more than one relapse within the last 12 months and no relapse within the last 6 months. 5. Urinary frequency of ? 8 times per 24-hours 6. Urinary urgency with or without urge incontinence 7. Have a record of MRI brain or spinal cord abnormalities consistent with the diagnosis of MS. 8. The 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 9. Baseline AST , alkaline phosphatase, Thyroid function, Serum Electrophoresis levels must be within the normal range for the laboratory conducting the test 10. Be able to adhere to the study visit schedule and other protocol requirements. 11. Capable of giving written informed consent. Consent must be obtained prior to any screening procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: If any of the following exclusion criteria are met, the patient is ineligible for the study: 1. Acute symptomatic urinary infection 2. Taking DDAVP for control of nocturia 3. Taking antimuscarinic agents for the control of overactive bladder symptoms 4. Full time wheelchair user. 5. History of immunosuppressant drug therapy of any kind in the last 3 months. 6. Relapse within the last 6 months. 7. No clear progression of disability in the last 12 months. 8. Co-existent medical condition precluding participation, including any history of severe allergic reaction. 9. Pregnant or lactating women and women who are planning pregnancy within 12 months of screening (i.e., approximately 6 months following last injection). 10. Receipt of any investigational drug within 30 days prior to screening or within 5 half-lives of the investigational agent, whichever is longer. 11. Treatment with any therapeutic agent targeted at reducing TNF (e.g., infliximab, pentoxifylline, thalidomide, etanercept, etc.) within 3 months of screening. 12. Previous administration of AIMSPRO. 13. Ongoing corticosteroid therapy or any corticosteroids within the previous 3 months. 14. History of known allergy to animal proteins. 15. Known history of tuberculosis. 16. Serious infections (such as pneumonia or pyelonephritis) in the previous 3 months. Less serious infections such as acute upper respiratory tract infection or simple urinary tract infection, should be followed to their conclusion or treated, as appropriate, prior to inclusion. 17. Patients with opportunistic infections, including but not limited to evidence of active cytomegalovirus, active Pneumocystis carinii, Aspergillosis, histoplasmosis or atypical mycobacterium infection, etc, within the previous 6 months. 18. Patients with established malignant disease, renal, hepatic, haematologic, gastrointestinal, endocrine, pulmonary, or cardiac disease. 19. Patients with a significant other neurological disorder. 20. Presence of a transplanted organ, with the exception of a corneal transplant > 3 months prior to screening. 21. History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly. 22. Known recent clinically significant substance abuse (drug or alcohol). 23. Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period. 24. Investigational drugs or drugs targeted at reducing TNF; infliximab, pentoxifylline, thalidomide, etanercept, or other agents are not allowed during participation in the study. 25. Patients will not be permitted to receive immunosuppressive treatment during this study. The exception will be where a patient’s treating neurologist determines that a course of steroid therapy, oral or intravenous, is required in view of a sufficiently disabling relapse of MS. 26. Ha

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Change in average voided volume; Main Objective: This is a proof of concept study. We seek to identify a signal that would justify further development of this drug, on the grounds of reasonable probability of true efficacy in the management of patients with multiple sclerosis (MS). To date, Some 400 patients with MS have now taken the medication for periods of up to 5 years. The most commonly reported benefit has been an improvement in bladder function, so it is judged that it would be best to conduct a proof of concept study on the overactive bladder symptoms associated with MS. The primary outcome measure will be the change in average voided volume ; Secondary Objective: The following secondary outcome measures will be studied Change in average 24-hour frequency of micturition Change in average 24-hour frequency of incontinence episodes Change in I-QOL score - An incontinence related quality of life measure Change in Whittington Urgency Score - A measure of the symptom of urinary urgency Change in Kurtzke Extended disability Scale Change in MSIS-29 - MS Impact scale Change in MS FC - Functional Composite Score Change in MS WS - Walking Scale Change in visual acuity and colour vision	—

Measure

Time frame

Primary end point(s): Change in average voided volume; Main Objective: This is a proof of concept study. We seek to identify a signal that would justify further development of this drug, on the grounds of reasonable probability of true efficacy in the management of patients with multiple sclerosis (MS). To date, Some 400 patients with MS have now taken the medication for periods of up to 5 years. The most commonly reported benefit has been an improvement in bladder function, so it is judged that it would be best to conduct a proof of concept study on the overactive bladder symptoms associated with MS. The primary outcome measure will be the change in average voided volume ; Secondary Objective: The following secondary outcome measures will be studied Change in average 24-hour frequency of micturition Change in average 24-hour frequency of incontinence episodes Change in I-QOL score - An incontinence related quality of life measure Change in Whittington Urgency Score - A measure of the symptom of urinary urgency Change in Kurtzke Extended disability Scale Change in MSIS-29 - MS Impact scale Change in MS FC - Functional Composite Score Change in MS WS - Walking Scale Change in visual acuity and colour vision

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Countries

United Kingdom

Outcome results

None listed