Primary aim of the study is to compare the efficacy and safety of two flowrates of ITB while maintaining a constant daily dose.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes are severity of pain and dystonia using a NRS.
Secondary outcome
1. Efficacy as evaluated by dystonia severity (Burke-Fahn-Marsden scale),
patient*s preference (PPQ), and global impression of improvement after each
treatment (global impression scale).
2. Safety of the procedure as evaluated by the occurrence of adverse events.
Background summary
In a recent dose-escalation study of intrathecal baclofen (ITB), 48 patients
who met a responsiveness criterion of 25% improvement as compared to placebo
were implanted with a programmable pump for continuous administration of ITB.
Surprisingly, only 65% of the 40 patients who actually received ITB reached a
similar response at 1 year follow-up. One potential explanation for this
finding is a prominent difference in applied flow rates between the screening
and implantation study. The flow rate applied during the screening was a factor
6 higher than in the implantation study.
Hence increasing the flow rate of ITB infusion may result in an improved
responsiveness of dystonia to this treatment.
Study objective
Primary aim of the study is to compare the efficacy and safety of two flowrates
of ITB while maintaining a constant daily dose.
Study design
The ITB flow rate study is a double-blind randomized two-period cross-over
study. Two different flow rates of ITB infusion are compared where one flow
rate is four times as high as the usual concentration of 3000 µg/ml. This is
achieved by administering a concentration of 750 µg/ml baclofen while daily
dose is kept unchanged. Each flow rate is maintained for 2 weeks in a
double-blind randomized cross-over design. Safety and efficacy are evaluated by
means of patient- and assessor-based evaluations.
Intervention
Intrathecal baclofen administered using a baseline flow rate (concentration
3000 microgr/ml) or 4 times higher (concentration 750 microgr/ml).
Study burden and risks
1. low-frequent visit to the hospital (in total 4 times, of which twice
clinical observation for at least 24 hours)
2. low risk of malprogramming (not enlarged compared to the current clinical
care)
Albinusdreef 2
2300 RC Leiden
Nederland
Albinusdreef 2
2300 RC Leiden
Nederland
Listed location countries
Age
Inclusion criteria
•Patients must suffer from tonic or intermittent dystonia in one or more extremities.
•Patients have an implanted programmable pump (SynchroMed® pump, Medtronic, Minneapolis MN, USA, 40 mL reservoir) for continuous intrathecal drug administration.
•Patients have shown an insufficient response to intrathecal baclofen (ITB) at the usual flow rate, that is a <25% improvement on dystonia severity while ITB was administered to a level of at least 1000 µg/day or lower because of dose-limiting side effects.
•Patients must report spontaneous dystonia of at least 5 on a numeric rating scale (0 represents no dystonia, 10 represents worst imaginable dystonia).
Exclusion criteria
Exclusion criteria are other causes of dystonia and pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-007436-25-NL |
| CCMO | NL21051.058.08 |