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

NCT01228396 | Unknown Phase 2 DMC

• 1 other identifier: DIMS04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Progressive Multiple Sclerosis

Keywords

bladder; optic neuritis; secondary progressive multiple sclerosis; AIMSPRO; hyperimmune caprine serum; hyperimmune goat serum

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Change in average 24-hour frequency

  At 0, 4, 10 and 14 weeks

• Change in visual acuity and colour vision

  At 0, 4, 10 and 14 weeks

• Change in average 24-hour incontinence

  At 0, 4, 10 and 14 weeks

• Change in urgency score

  At 0, 4, 10 and 14 weeks

• Change in I-QOL score

  At 0, 4, 10 and 14 weeks

Interventions

Hyperimmune caprine serum against HIV lysate DRUG

1.0ml solution for subcutaneous injection (4.5mg total protein / ml) twice weekly for 4 weeks

Also known as: AIMSPRO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Patients with opportunistic infections within the previous 6 months.
• Established malignant disease, renal, hepatic, haematologic, gastrointestinal, endocrine, pulmonary, or cardiac disease.

Sponsors & Collaborators

• Daval International Limited: lead

Study Sites (1)

Royal Free Hospital Hampstead NHS Trust

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Optic Neuritis

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases

Study Officials

• James Malone-Lee, MD

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 26, 2010
• First Posted: October 26, 2010
• Study Start: May 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: March 1, 2012
• Last Updated: August 18, 2011

Record last verified: 2011-08

Locations

GB (1)