AIMSPRO in the Treatment of Bladder Dysfunction in Secondary Progressive Multiple Sclerosis

Secondary Progressive Multiple Sclerosis Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled Study of AIMSPRO in Treating Bladder Dysfunction in Secondary Progressive Multiple Sclerosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01228396
• Other study ID #: DIMS04
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 26, 2010
• Last updated: August 16, 2011
• Start date: May 2009
• Est. completion date: March 2012

Study information

• Verified date: August 2011
• Source: Daval International Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Description:

Treatment periods of 4 weeks' duration are separated by a 6 week wash-out phase. After 14 weeks of randomised therapy there is a 38 week period of "open-label" AIMSPRO treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: March 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 following last injection).

• Receipt of any investigational drug within 30 days prior to screening or within 5 half-lives of the investigational agent, whichever is longer.

• Treatment with any therapeutic agent targeted at reducing TNF (e.g., infliximab, pentoxifylline, thalidomide, etanercept, etc.) within 3 months of screening.

• Previous administration of AIMSPRO.

• Ongoing corticosteroid therapy or any corticosteroids within the previous 3 months.

• History of known allergy to animal proteins, tuberculosis.

• 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.

• Patients with opportunistic infections within the previous 6 months.

• Established malignant disease, renal, hepatic, haematologic, gastrointestinal, endocrine, pulmonary, or cardiac disease.

• Significant other neurological disorder.

• Presence of a transplanted organ, with the exception of a corneal transplant > 3 months prior to screening.

• 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.

• Recent clinically significant substance abuse (drug or alcohol).

• Poor tolerability of venipuncture.

• Investigational drugs or drugs targeted at reducing TNF are not allowed during participation in the study.

• 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.

• Immunosuppressive therapy within the month prior to entry into the study.

• Taking the licensed anticonvulsant medication lamotrigine or the anti-arrhythmic drug flecainide, both of which are potent sodium channel blocking agents.

• Unable to fill in the criteria related to bladder dysfunction status.

• Unable to give written informed consent.

• Use of intermittent or indwelling urinary catheter.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Neoplasm Metastasis
• Sclerosis
• Secondary Progressive Multiple Sclerosis

Intervention

Drug:
• Hyperimmune caprine serum against HIV lysate
1.0ml solution for subcutaneous injection (4.5mg total protein / ml) twice weekly for 4 weeks

Locations

Country	Name	City	State
United Kingdom	Royal Free Hospital Hampstead NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Daval International Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in average voided volume	The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.	At 0, 4, 10 and 14 weeks	No
Secondary	Change in average 24-hour frequency	The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.	At 0, 4, 10 and 14 weeks	No
Secondary	Change in visual acuity and colour vision	Employs logMAR based and Farnsworth-Munsell 100 Hue testing. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.	At 0, 4, 10 and 14 weeks	No
Secondary	Change in average 24-hour incontinence	The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.	At 0, 4, 10 and 14 weeks	No
Secondary	Change in urgency score	The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.	At 0, 4, 10 and 14 weeks	No
Secondary	Change in I-QOL score	The Incontinence - Quality of Life questionnaire is administered at the beginning and end of each four week treatment phase. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.	At 0, 4, 10 and 14 weeks	No
Secondary	Change in Whittington Urgency Score	The Whittington Urgency Score is administered at the beginning and end of each four week treatment phase. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.	At 0, 4, 10 and 14 weeks	No
Secondary	Change in Kurtzke EDS	The Kurtzke EDS assessment is undertaken at the beginning and end of each four week treatment phase. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.	At 0, 4, 10 and 14 weeks	No
Secondary	Change in MSIS-29	The Multiple Sclerosis Impact Scale is administered at the beginning and end of each four week treatment phase. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.	At 0, 4, 10 and 14 weeks	No
Secondary	Change in MS FC	The The Multiple Sclerosis Functional Composite assessment is undertaken at the beginning and end of each four week treatment phase. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.	At 0, 4, 10 and 14 weeks	No
Secondary	Change in MS WS	The Multiple Sclerosis Walking Scale is assessed at the beginning and end of each four week treatment phase. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.	At 0, 4, 10 and 14 weeks	No