Trigeminal neuralgia Nervous System Diseases Trigeminal neuralgia
Conditions
Interventions
Added 15/09/2008:
Treatment with three applications of 0.5 g/kg IVIG or normal saline
Initially proposed interventions:
Treatment with three applications of 10 g IVIG or normal saline
Sponsors
University College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients suffering from primary trigeminal neuralgia refractory to carbamazepine therapy Added 15/09/2008: Patients are suitable for consideration for screening and enrolment if they have received a diagnosis of primary trigeminal neuralgia (TN) according to International Headache Society criteria including both 'classical TN' and with features of 'atypical TN', provided they initially presented with 'classical TN'. 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 that 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 that is considered by the respective consultant grade site investigator to have emerged following an interventional procedure aimed at relieving pain from trigeminal neuralgia. Patients who have had previous successful surgical treatments but who have suffered a recurrence of classical or atypical trigeminal neuralgia or have developed a constant element to their pain 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 enrolment. Patients fulfilling the above listed suitability criteria may be screened if they: 1. 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 2. Are male or female above 18 years of age 3. Are females and there is evidence that they are not pregnant or lactating or that they are post-menopausal. A urine pregnancy test will be performed on the day of the first infusion if no other credible evidence such as of either sterilisation or post-menopausal status is given. Confirmation of the use of adequate birth control will be required in pre menopausal women, which give no evidence for an inability to become pregnant. 4. Have no physical condition, which, in the opinion of the investigator, is unstable or would otherwise prevent the patient from completing the study. 5. Have sufficient cognitive function and English language skills to complete questionnaires, keep a daily diary, use an electronic diary, and communicate verbally with the nursing staff. English language skills are required because not all the questionnaires have been translated or validated in other languages. 6. 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 at the first appointment by
Exclusion criteria
Exclusion criteria: Added 15/09/2008: Following patients with facial pain are not suitable for inclusion: 1. Trigeminal neuropathic pain defined by a main component of continuous pain (even if shooting/sharp pains superimposed) 2. Symptomatic TN (multiple sclerosis [MS], tumour) 3. Concomitant non-neuropathic pain which is moderate/severe (e.g., temporomandibular disorder [TMD]) 4. Sharp, shooting pain and autonomic symptoms (= trigemino-autonomic cephalalgias) 5. Patients with frequent spontaneous remissions as judged by the treating consultant 6. Typical/atypical TN waiting for surgery which is imminent (within less than 4 months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Initially proposed outcome: Primary outcome variable defined as the length of time during which patients remain in the study. Study groups are compared using Kaplan-Maier survival analysis. Patients record their response to treatment ("severe, moderate, slight, no pain"). The study coordinator monitors pain diaries. Severe or moderate pain of three days duration will result in termination of the study for that patient. Added 15/09/2008: The primary outcome measure for a patient is whether he/she drops out of the trial before day 14 (day 1 is the 1st day of infusion). A patient dropping out before day 14 is labelled a ?failure?. Patients are removed from the trial as per protocol: "If from study day 6 at any time for three consecutive days the average pain intensity is noted either as 'severe' or as 'moderate'. If noted as 'moderate' the patient?s overall impression of change is less than 'much improved' on the 'impression of change' scale." | — |
Secondary
| Measure | Time frame |
|---|---|
| Added 15/09/2008: 1. The report by a patient of a significant reduction in the number of those attacks ('paroxysms') with a pain intensity of greater than 4 NRS. Significant reduction is defined as a greater than 75% reduction of spontaneous attacks and a greater than 50% reduction of evoked attacks. This is measured over 24 hours at:1.1. Day 8, and 1.2. In addition on day 13 (intention to treat analysis for day 13) 2. The global impression of change as noted for the period starting from day 9 to day 13 inclusive (intention to treat analysis) | — |
Countries
United Kingdom
Outcome results
None listed