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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Daval International Limited.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Daval International Limited
ClinicalTrials.gov Identifier:
NCT01228396
First received: September 26, 2010
Last updated: August 16, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Secondary Progressive Multiple Sclerosis
Drug: Hyperimmune caprine serum against HIV lysate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Study of AIMSPRO in Treating Bladder Dysfunction in Secondary Progressive Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Daval International Limited:

Primary Outcome Measures:
  • Change in average voided volume [ Time Frame: At 0, 4, 10 and 14 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 0, 4, 10 and 14 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 0, 4, 10 and 14 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 0, 4, 10 and 14 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 0, 4, 10 and 14 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 0, 4, 10 and 14 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 0, 4, 10 and 14 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 0, 4, 10 and 14 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 0, 4, 10 and 14 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 0, 4, 10 and 14 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 0, 4, 10 and 14 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: May 2009
Estimated Study Completion Date: March 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Hyperimmune caprine serum against HIV lysate
    1.0ml solution for subcutaneous injection (4.5mg total protein / ml) twice weekly for 4 weeks
    Other Name: AIMSPRO
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228396

Locations
United Kingdom
Royal Free Hospital Hampstead NHS Trust
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Daval International Limited
Investigators
Principal Investigator: James Malone-Lee, MD University College, London
  More Information

No publications provided

Responsible Party: Dr. Bryan Youl, Daval International Limited
ClinicalTrials.gov Identifier: NCT01228396     History of Changes
Other Study ID Numbers: DIMS04
Study First Received: September 26, 2010
Last Updated: August 16, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Daval International Limited:
bladder
optic neuritis
secondary progressive multiple sclerosis
AIMSPRO
hyperimmune caprine serum
hyperimmune goat serum

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Chronic Progressive
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 14, 2014