Back to resultsAIMSPRO in the Treatment of Bladder Dysfunction in Secondary Progressive Multiple Sclerosis
Primary Purpose
Secondary Progressive Multiple Sclerosis
Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Hyperimmune caprine serum against HIV lysate
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Progressive Multiple Sclerosis focused on measuring bladder, optic neuritis, secondary progressive multiple sclerosis, AIMSPRO, hyperimmune caprine serum, hyperimmune goat serum
Eligibility Criteria
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.
Sites / Locations
- Royal Free Hospital Hampstead NHS Trust
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT01228396
First Posted
September 26, 2010
Last Updated
August 16, 2011
Sponsor
Daval International Limited
1. Study Identification
Unique Protocol Identification Number
NCT01228396
Brief Title
AIMSPRO in the Treatment of Bladder Dysfunction in Secondary Progressive Multiple Sclerosis
Official Title
A Randomised, Double-blind, Placebo-controlled Study of AIMSPRO in Treating Bladder Dysfunction in Secondary Progressive Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
March 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Daval International Limited
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Progressive Multiple Sclerosis
Keywords
bladder, optic neuritis, secondary progressive multiple sclerosis, AIMSPRO, hyperimmune caprine serum, hyperimmune goat serum
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Hyperimmune caprine serum against HIV lysate
Other Intervention Name(s)
AIMSPRO
Intervention Description
1.0ml solution for subcutaneous injection (4.5mg total protein / ml) twice weekly for 4 weeks
Primary Outcome Measure Information:
Title
Change in average voided volume
Description
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.
Time Frame
At 0, 4, 10 and 14 weeks
Secondary Outcome Measure Information:
Title
Change in average 24-hour frequency
Description
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.
Time Frame
At 0, 4, 10 and 14 weeks
Title
Change in visual acuity and colour vision
Description
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.
Time Frame
At 0, 4, 10 and 14 weeks
Title
Change in average 24-hour incontinence
Description
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.
Time Frame
At 0, 4, 10 and 14 weeks
Title
Change in urgency score
Description
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.
Time Frame
At 0, 4, 10 and 14 weeks
Title
Change in I-QOL score
Description
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.
Time Frame
At 0, 4, 10 and 14 weeks
Title
Change in Whittington Urgency Score
Description
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.
Time Frame
At 0, 4, 10 and 14 weeks
Title
Change in Kurtzke EDS
Description
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.
Time Frame
At 0, 4, 10 and 14 weeks
Title
Change in MSIS-29
Description
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.
Time Frame
At 0, 4, 10 and 14 weeks
Title
Change in MS FC
Description
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.
Time Frame
At 0, 4, 10 and 14 weeks
Title
Change in MS WS
Description
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.
Time Frame
At 0, 4, 10 and 14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Malone-Lee, MD
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Free Hospital Hampstead NHS Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
AIMSPRO in the Treatment of Bladder Dysfunction in Secondary Progressive Multiple Sclerosis
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