A Phase 2 interventional study of NT 201 in Blepharospasm, sponsored by Merz Pharmaceuticals GmbH. Terminated at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-02-06.
Sponsored by Merz Pharmaceuticals GmbH (part of Merz Pharma) · Phase 2, Interventional, and Treatment
The objective of this Phase II study is to show that pre-treated patients with BEB with the need of shortened injection intervals achieve an improved and stable quality of life level if they receive repeated NT 201 injections at short injection intervals. In addition, the tolerability of repeated shortened NT 201 administrations in patients with BEB including the development of neutralizing antibodies will be investigated.
42 studies on the registry are indexed under Blepharospasm; 1 is open to participants now.
This study's enrollment of 8 is below the median of 40 across 28 interventional studies indexed under Blepharospasm.
Browse Blepharospasm studies →Merz Pharmaceuticals GmbH is the lead sponsor of 61 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: NT 201
Injection of up to 50 Units NT 201 (incobotulinumtoxinA/Xeomin®) per eye and injection visit (8 injections visits in total).
Also known as: Xeomin®, IncobotulinumtoxinA, "Botulinum toxin type A (150 kiloDalton), free from complexing proteins"
The difference between the actual Blepharospasm Disability Index [BSDI] value at each follow up visit and the BSDI value at baseline.
The BSDI includes 6 items to be assessed by a 5-point scoring (i.e., 0-4 points per item) ranging from "no impairment, "slight impairment", "moderate impairment", "severe impairment" to "no longer possible due to my illness". The 6 items are "Driving a vehicle", "Reading", "Watching TV", "Shopping", "Walking" and "Doing everyday activities".
Time frame: From baseline up to week 62. Follow up visits include 8 injection visits (V2 to V8) with intervals of at least 6 weeks between injections.
Change in Jankovic Rating Scale (JRS) score from baseline over time.
The JRS ranges from 0-8 points and consists of the two items "Severity" and "Frequency" with five rating categories each (0-4 points).
Time frame: From baseline up to week 62
Patient Evaluation of Global Response [PEGR] rated by patient at visits V2 to V8 and at follow-up visit
The PEGR scale is a descriptive subjective 9-point response self-rating scale ranging from "complete abolishment of signs and symptoms" (+4) down to "very marked worsening" (-4).
Time frame: Week 6 up to week 62
The record gives a start of Aug 2007, a primary completion of Feb 2008 and a completion of Feb 2008. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: incobotulinumtoxinA