| Source of record | National Research Register |
| Serial number at source | N0265041711 |
| Project title | Randomised, Double-Blind, Placebo-Controlled, Exploratory, Safety Study of Recombitant beta- interferon la Given by subcutaneous Injection three times a week to Patients Suffering from Guillain-Barre Syndrome. |
| Current status of trial | Complete |
| Main research question | Primary Objective:
To investigate the safety and tolerability of treatment with REBIF (44ug subcutaneously three times a week) for up to 24 weeks in patients suffering from Guillain-Barrt syndrome (GBS). It is hypothesised that there will be no serious, dose-limiting, adverse events related to REBIF in this trial. REBIF has been well tolerated in patients with multiple sclerosis with only minor adverse events, but never used at this dose or in patients with GBS. Secondary Objective: To conduct pilot investigations of the effect of treatment with REBIF (44ug subcutaneously three times a week) on overall disability in patients suffering from GBS (at 4 and 24 weeks after the initiation of such treatment). |
| Design/methodology | This is a phase 1 exploratory, placebo-controlled, double-blind, parallel randomised study. Patients with GBS within 14 days of onset and affected severely enough to be unable to walk 10 metres will be enrolled at six centres. Twenty one patients will be randomised, 14 to receive REBIF 44ug and 7 placebo. Medication will be given by subcutaneous injection three times per week, and continued until the patient can walk 10 metres unaided (for a maximum of 24 weeks). Patients will be monitored for 28 weeks for adverse events, and by disability grade, muscle power, nerve conduction tests and immunological blood assays.
The primary endpoint will be the incidence of adverse events and laboratory abnormalities. The secondary endpoints will be the changes in disability grade four and 24 weeks from randomisation, and the proportion of patients able to walk unaided at two, four, 12 and 24 weeks after randomisation. |
| Sample group description | All eligible patients with Guillain-Barre Syndrome at participating hospitals will be invited to enter the trial. |
| Multi-centre trial? | This is not a multi-centre trial. |
| Outcome measure | The primary endpoint will be the incidence of adverse events and laboratory abnormalities. The secondary endpoints will be the changes in disability grade four and 24 weeks from randomisation, and the proportion of patients able to walk unaided at two, four, 12 and 24 weeks after randomisation. |
| Start date | 10/16/1998 |
| End date | 12/16/2001 |
| Primary keywords | POLYRADICULONEURITIS Q-drug-therapy; INTERFERON-BETA Q-therapeutic-use |
| Secondary keywords | HUMAN; CLINICAL-TRIAL; RANDOMIZED-CONTROLLED-TRIAL; DOUBLE-BLIND-METHOD; PLACEBO-EFFECT; INJECTIONS-SUBCUTANEOUS; SAFETY; DRUG-TOLERANCE; DISABILITY-EVALUATION; TREATMENT-OUTCOME |
| Region | West Midlands Regional Office |
| NRR Data Provider | University Hospital Birmingham NHS Trust |
| Funding organisation: name 1 | Serono Laboratories UK |
Funding amount 1
[in £ unless otherwise stated] | 7500 |
| Contact name(s) | Dr JB Winer |
| Contact details | Neurology
Queen Elizabeth Hospital
Birmingham
B15 2TH
Tel: 0121 472 1311 |
| Further information | This record was taken from the National Research Register 2003, Issue 1, published in February 2003. Further information about this trial can be obtained from the lead researcher named above. |
| Date live in mRCT | 6 February 2003 |
