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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   42336   clinical trials with a EudraCT protocol, of which   6971   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2007-004226-25
    Sponsor's Protocol Code Number:07/O21
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-10-15
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2007-004226-25
    A.3Full title of the trial
    Low-dose intravenous immunoglobulin or 0.9% saline in the treatment of trigeminal neuralgia refractory to carbamazepine – a randomized double blind parallel placebo-controlled multicentre trial in an outpatient setting.
    A.3.2Name or abbreviated title of the trial where available
    Intravenous immunoglobulin in the treatment of refractory trigeminal neuralgia.
    A.4.1Sponsor's protocol code number07/O21
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUCL
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    B.Sponsor: 2
    B.1.1Name of SponsorUCL
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    B.Sponsor: 3
    B.1.1Name of Sponsor
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGamunex
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product Yes
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboIntravenous infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Trigeminal neuralgia is a severe neuropathic facial pain that currently can often not be well controlled pharmacologically. The gold standard for medical treatment remains carbamazepine, which may produce severe side effects and numerous drug interactions, or may not be effective. There is a recognized need to find other drugs that will provide pain relief with fewer side effects than carbamazepine, or in such cases where carbamazepine is without effect.

    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10044652
    E.1.2Term Trigeminal neuralgia
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the study is to confirm the efficacy and tolerability of immunomodulation with low dose IVIG in refractory trigeminal neuralgia.
    E.2.2Secondary objectives of the trial
    We also expect that this trial can provide a basis for other larger trials both in trigeminal neuralgia and also in other refractory neuropathic pain conditions.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are suitable for consideration for screening and enrollment if they have received a diagnosis of trigeminal neuralgia (TN) according to International Headache Society criteria including both ‘classical TN’, or with features of ‘atypical TN’ (Burchiel 2003) providing they initially presented with ‘classical TN’ (Nurmikko and Eldridge 2001). For clarity, these criteria are listed here:
    A. Paroxysmal attacks of pain lasting from a fraction of a second to 2 minutes, affecting one or more division of the trigeminal nerve and fulfilling criteria B and C
    B. Pain has at least one of the following characteristics
    1. Intense, sharp, superficial or stabbing
    2. Precipitated from trigger areas or by trigger factors
    C. Attacks are stereotyped in the individual patient
    D. There is no clinically evident neurological deficit
    E. Not attributed to another disorder
    Patients are suitable if they report a dull, burning pain after the shooting paroxysms which then also disappears (atypical form). In addition, there may be a constant element to the pain, but only if in the judgement of the consultant pain specialists responsible for enrolling the patient this patient has had on initial presentation a credible diagnosis of classical trigeminal neuralgia (without a constant element). In addition, patients are also suitable if they have a neurological deficit which is considered by one of the consultant grade site investigators to have emerged following an interventional procedure aimed to relieve pain from TN. Patients who have had previous successful surgical treatments but who have suffered a recurrence of classical or atypical TN are suitable. Patients on a stable dose of antiepileptic drugs are suitable. Treatment with antiepileptic drugs prior to enrolment will be noted, but prior treatment with antiepileptic drugs other than carbamazepine is not a prerequisite for consideration for screening and enrollment.
    Patients fulfilling the above listed suitability criteria may be screened if they
    • are willing to participate in the study as evidenced by giving written informed consent and willingness to return to the study site at the intervals specified in the protocol.
    • are male or female above 18 years of age.
    • are females and there is evidence that they are not pregnant or lactating. A urine pregnancy test will be performed on the day of the first infusion. Confirmation of use of adequate birth control will be required.
    • have no physical condition, which, in the opinion of the investigator, is unstable or would otherwise prevent the patient from completing the study.
    • have sufficient cognitive function and English language skills or the availability of a translator to complete questionnaires, keep a daily diary, use an electronic diary, and communicate verbally with the nursing staff. English language skills or the availability of a translator are required because not all the questionnaires have been translated or validated in other languages.
    • are receiving a stable dose of an antiepileptic drug, with adequate pain control, but experience a poor side-effect profile, as judged by both the patient (documented by ticking ‘non acceptable’ to a question: ‘do you consider side effects from your medication taken for pain acceptable – non acceptable) and the consultant-grade site investigator.
    Patients may be enrolled if they
    • have an average 24h pain severity of >4 on a numeric scale of 0-10 during the seven day screening period and at least moderate on a scale none-mild-moderate-severe. During an initial patient-education module the use of these scales will be explained in detail. For example if patients only experience attacks, without any constant element, then the mean intensity of painful attacks will be noted. If the pain level when taking medication is lower, but adverse events associated with that medication are considered not acceptable (see above), then the respective medication would first be reduced, and a stable pain level in accordance with the entry criteria be achieved for at least four consecutive
    E.4Principal exclusion criteria
    All patients have their serum IgA level tested and if less than half the normal value then the patient may be excluded. In patients with an absence of IgA or with severe IgA deficiency, it is believed that IVIG administration will result in the formation of immune complexes between IgA antibodies present in the drug and traces of preformed anti IgA in patients (Kazatchkine and Kaveri 2001). Pregnant or lactating females are excluded from the study. Patients with progressive renal failure, bedridden patients and any patient requiring IVIG for another disorder are excluded. Treatment will be deferred in patients with an infection such as cold, flu or infected pressure sores until the infection has resolved, because previous experience has shown a reduced analgesic effect of IVIG in these cases. Further, patients are excluded, should they
    • have evidence of significant organic disease on history or physical examination, which may be severe enough to prevent the patient from being able to complete the study.
    • suffer from another severe chronic pain syndrome which may in the judgement of the site investigator hinder the appropriate assessment of pain from trigeminal neuralgia
    • have a history of or are currently abusing alcohol or drugs.
    • take carbamazepine plus other medication that may interact with carbamazepine , e.g. warfarin
    • have a psychological/psychiatric disorder as identified by a pre-study entry psychiatric assessment.
    • be unwilling to complete daily diaries.
    For the following patients suitability for participation needs to be discussed with a specialist consultant: patients with compensated renal failure, patients suffering from epilepsy, patients with a history of stroke or myocardial infarction and patients with a known procoagulatory or blood-hyperviscosity disorder. It is expected that, following discussion with the respective consultant usually these patients can participate, but the maximal infusion rate will be reduced to half the usual infusion rate in most patients with renal failure or a history of stroke or myocardial infarction.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the number of patients remaining in the trial at day 14 because they experience significant pain relief.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-10-15. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state32
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-06-17
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