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NCT00471744: HEAD
HEAD-TO-HEAD Evaluation of the Antiepileptic Drugs Levetiracetam (LEV) vs. Sulthiame (STM) in a German Multi-Centre, Doubleblind Controlled Trial in Children With Benign Epilepsy With Centro-Temporal Spikes
Phase 3 trial testing Treatment with levetiracetam or sulthiame over a six-month period. in Epilepsy, Rolandic in 44 participants. Terminated before completion.
Quick facts
| Lead sponsor | Ludwig-Maximilians - University of Munich |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 44 |
| Start date | 1 June 2006 |
| Estimated completion | 1 July 2008 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Treatment with levetiracetam or sulthiame over a six-month period. — full drug profile →
Conditions studied
- Epilepsy, Rolandic — all drugs for Epilepsy, Rolandic →
Sponsor
Ludwig-Maximilians - University of Munich
Who can join
Adults 6 to 12, any sex, with Epilepsy, Rolandic. 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.
-
To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame
Time frame: 6 months
Sponsor's own description
The investigators hypothesize that Levetiracetam is as effective as Sulthiame in the treatment of children with BECTS. Patients entering the HEAD-Studie are either treated with Leveitracetam or Sulthiame over a 6 months period. Patients are equally randomised to one of the two treatment regimens. Administration of medication as blinded capsules.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00471744
- Europe PMC full search
- ASCO Meeting Library
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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 NCT00471744 (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 Ludwig-Maximilians - University of Munich
- Last refreshed: 28 January 2009
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/NCT00471744.
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