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NCT00367068
Intrathecal Baclofen. Evaluation of a Therapy for Refractory Spasticity in Children With Cerebral Palsy
Phase 3 trial testing baclofen, intrathecal in Cerebral Palsy in 18 participants. Completed in 1 May 2007.
Quick facts
| Lead sponsor | Maastricht University |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 1 January 2002 |
| Estimated completion | 1 May 2007 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- baclofen, intrathecal — full drug profile →
- infusion pump for intrathecal baclofen, Synchromed, Medtronic
Conditions studied
- Cerebral Palsy — all drugs for Cerebral Palsy →
- Spasticity — all drugs for Spasticity →
Sponsor
Maastricht University
Who can join
Adults 4 to 16, any sex, with Cerebral Palsy or Spasticity. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- For the double-blind, placebo-controlled dose-escalation test treatment phase:
- original Ashworth Scale.
- For the prospective, randomized, open-label implantation and follow-up phase:
- PEDI, GMFM, original Ashworth Scale, Visual Analogue Scale (VAS) at 6 months.
Sponsor's own description
The objective of this study is to determine the efficacy and safety of treatment with intrathecal baclofen for severe spasticity in children with cerebral palsy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00367068
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Maastricht University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00367068 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Maastricht University
- Last refreshed: 15 November 2007
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00367068.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing