Evidence map›Paper›PMID 15959841›Full record

Trial reportJournal of neural transmission (Vienna, Austria : 1996)2006

Efficacy and safety of a new Botulinum Toxin Type A free of complexing proteins in the treatment of blepharospasm.

P Roggenkämper, W H Jost, K Bihari, G Comes, S Grafe, NT 201 Blepharospasm Study Team

Abstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Journal of neural transmission (Vienna, Austria : 1996), 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 81 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 3 pooled it
6.3field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

81 citing papers in PubMed, 3 syntheses or guidelines pooled it, 246 citations in OpenAlex.

  1. Pooled it
  2. Dystonia rating scales: critique and recommendations.Movement disorders : official journal of the Movement Disorder Society · 2013
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  14. [Treatment of crow's feet with two different botulinum toxin type A preparations in split-face technique].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2011
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  16. [Does dilution have an impact on cosmetic results with BoNT/A? Complex-protein-free BoNT/A for treatment of glabella lines].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2009
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21 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 2 countries.

P RoggenkämperDepartment of Ophthalmology, University of Bonn, Wiesbaden, Germany. proggenk@uni-bonn.de
W H Jost
K Bihari
G Comes
S Grafe
NT 201 Blepharospasm Study Team
MerLion Pharma (Germany) · DEDeutsche Klinik für Diagnostik · DEOrszágos Idegsebészeti Tudományos Intézet · HUUniversity of Bonn · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

NT 201 is a new development of Botulinum Toxin Type A free of complexing proteins. In this double-blind Phase III trial, we compared the efficacy and safety of NT 201 and BOTOX in patients suffering from blepharospasm. Of 304 enrolled patients, 300 patients received study medication (intent-to-treat population), and 256 patients completed the study as planned (per-protocol population). At baseline, patients received a single injection of NT 201 or BOTOX (<or=35 units per eye). No significant differences were found between NT 201 and BOTOX for all efficacy and safety variables three weeks after injection. Both the NT 201 and the BOTOX group showed a decrease in the Jankovic Rating Scale (JRS) sum score signifying an improvement in the symptoms of blepharospasm during this time period. These data show that NT 201* is an effective and safe treatment for patients suffering from blepharospasm.

Indexed as

AdultAgedAged, 80 and overBlepharospasmBotulinum Toxins, Type ADouble-Blind MethodEyelidsFemaleHemagglutininsHumansMaleMiddle AgedMuscle, SkeletalNeuromuscular AgentsTreatment OutcomeBotulinum Toxins, Type AHemagglutininsincobotulinumtoxinANeuromuscular Agents

Identifiers

PMID15959841
OpenAlexW2027882596

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.