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Secondary Progressive Multiple SclerosisPhase 2NCT01228396

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

A Phase 2 study testing Hyperimmune caprine serum against HIV lysate in people with Secondary Progressive Multiple Sclerosis, run by Daval International Limited at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Secondary Progressive Multiple Sclerosis
What is being tested?
Hyperimmune caprine serum against HIV lysate
Type of treatment
Injection or infusion
How many people
20 participants
Where
1 siteUnited Kingdom
Study dates
May 2009to Mar 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Royal Free Hospital Hampstead NHS Trust

    London, NW3 2QG

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
Hyperimmune caprine serum against HIV lysate
Keywords
bladder, optic neuritis, secondary progressive multiple sclerosis, AIMSPRO, hyperimmune caprine serum, hyperimmune goat serum
Medical subject headings
Multiple Sclerosis, Chronic Progressive, Optic Neuritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyperimmune caprine serum against HIV lysateDrug

    Also called AIMSPRO

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 0, 4, 10 and 14 weeks

Secondary outcomes (10)

  1. 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.

    Measured: At 0, 4, 10 and 14 weeks

  2. 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.

    Measured: At 0, 4, 10 and 14 weeks

  3. 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.

    Measured: At 0, 4, 10 and 14 weeks

  4. 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.

    Measured: At 0, 4, 10 and 14 weeks

  5. 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.

    Measured: At 0, 4, 10 and 14 weeks

  6. 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.

    Measured: At 0, 4, 10 and 14 weeks

  7. 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.

    Measured: At 0, 4, 10 and 14 weeks

  8. 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.

    Measured: At 0, 4, 10 and 14 weeks

  9. 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.

    Measured: At 0, 4, 10 and 14 weeks

  10. 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.

    Measured: At 0, 4, 10 and 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2010 (estimated)
  2. Study startMay 2009
  3. Primary completionMay 2011
  4. Study completionMar 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01228396
Sponsor's protocol ID
DIMS04
Status last verified
Aug 2011
First submitted
26 Sep 2010
Last updated
18 Aug 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hyperimmune caprine serum against HIV lysate in people with Secondary Progressive Multiple Sclerosis, run by Daval International Limited at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in average voided volume (time frame: At 0, 4, 10 and 14 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01228396.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2011.

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