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Record W2128508579 · doi:10.1016/j.pmrj.2011.08.164

Poster 130 Sustained Efficacy of IncobotulinumtoxinA (XEOMIN; botulinum neurotoxin type A, free from accessory proteins) in Cervical Dystonia Demonstrated by Investigator‐ and Patient‐rated Outcomes

2011· article· en· W2128508579 on OpenAlexaboutno aff
Dirk Dressler, B Gebhardt, Andrea Kupsch, Sebastian Paus, Andrea Seitzinger

Bibliographic record

VenuePM&R · 2011
Typearticle
Languageen
FieldMedicine
TopicBotulinum Toxin and Related Neurological Disorders
Canadian institutionsnot available
Fundersnot available
KeywordsCervical dystoniaBotulinum neurotoxinMedicineBotulinum toxinPhysical medicine and rehabilitationSurgeryBiologyGenetics

Abstract

fetched live from OpenAlex

D. Dressler, Allergan, consulting fees or other remuneration; Eisai, consulting fees or other remuneration; Ipsen, consulting fees or other remuneration; Merz, consulting fees or other remuneration. To assess the long-term efficacy and tolerability of incobotulinumtoxinA in cervical dystonia (CD) in a setting similar to clinical practice. Prospective, multicenter, open-label, single-arm phase IV study (≤121 weeks duration). 17 centers across Germany. Patients with CD. Patients received up to 5 injection series (IS) of incobotulinumtoxinA. The interval between each injection session was 10-24 weeks, depending on the clinical need. Investigators were free to choose the pattern of muscles injected, the number of injection sites, and the total dose injected (maximum, 300 U). Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), Dystonia Discomfort Scale (DDS) (a newly developed patient diary), Global Assessment of Efficacy (as rated by the investigator), Patient Evaluation of Global Response, Investigator Global Assessment of Tolerability. Seventy-six patients were enrolled. Nineteen patients were treatment naïve to botulinum toxin, and 57 had received previous injections of botulinum neurotoxin type A. Mean change in TWSTRS-Total score from study baseline to 4 weeks after each IS was –11.7 (IS 1), –13.6 (IS 2), –13.4 (IS 3), –13.9 (IS 4), and –14.3 (IS 5) (data of Full Analysis Set; missing values imputed with LOCF). Similar improvements in DDS score were observed. The absolute change in DDS score was stable across all IS. After each IS, up to 81% of investigators rated efficacy as “good” or “very good.” The proportion of patients rating global response as +2 (moderate improvement) or greater was 77.6% (IS 1), 67.1% (IS 2), 72.4% (IS 3), 64.5% (IS 4), and 78.9% (IS 5). The Investigator Global Assessment of Tolerability was reported as “good” or “very good” for most patients. IncobotulinumtoxinA showed sustained efficacy and was well tolerated for the treatment of CD in a study with a duration up to 121 weeks. Clinical measures of efficacy were supported by investigator- and patient-rated outcomes.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.000
metaresearch head score (Gemma)0.001
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMeta-epidemiology (narrow)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.061
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0000.001
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.001
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0010.001
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.025
GPT teacher head0.246
Teacher spread0.222 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations0
Published2011
Admission routes1
Has abstractyes

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