Blepharospasm Short Interval

Merz Pharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

Blepharospasm

Treatments

Drug: NT 201

Study type

Interventional

Funder types

Industry

Identifiers

NCT00507637

MRZ 60201-0703/1

2007-000697-23 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A clinical diagnosis of bilateral BEB characterized by spontaneous, spasmodic, intermittent or persistent involuntary contractions of the orbicular oculi muscles
Medical need for treatment with shortened injection intervals (< 12 weeks) confirmed by the patient and investigator
Blepharospasm Disability Index (BSDI) at baseline visit before injection of > / = 1,6

Exclusion criteria

Atypical variant of blepharospasm caused by inhibition of levator palpebrae muscle (apraxia of the eyelid)
Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome), as well as amyotrophic lateral sclerosis or any other significant neuromuscular disease which might interfere with the trial
The previous three injections with Botulinum toxin Type A with more than 50 Units [U] per eye per injection session
Treatment with Botulinum toxins for any indication other than BEB within 4 months prior to baseline and during the trial