---
title: Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm
nct_id: NCT01259557
overall_status: COMPLETED
phase: PHASE4
sponsor: Medy-Tox
study_type: INTERVENTIONAL
primary_condition: Essential Blepharospasm
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01259557.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01259557"
ct_last_update_post_date: 2012-04-25
last_seen_at: "2026-05-12T07:15:23.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm

**Official Title:** Multi-center, Phase Ⅳ, Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Meditoxin® in Subjects With Essential Blepharospasm

**NCT ID:** [NCT01259557](https://clinicaltrials.gov/study/NCT01259557)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 110
- **Lead Sponsor:** Medy-Tox
- **Conditions:** Essential Blepharospasm
- **Start Date:** 2010-08
- **Completion Date:** 2011-08
- **CT.gov Last Update:** 2012-04-25

## Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of Essential blepharospasm.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Men and women aged above 18
* Subjects who was diagnosed with Essential Blepharospasm
* Subjects who voluntarily Signed written informed consent
* Subjects who can adhere to protocol and study requirements

Exclusion Criteria:

* Subjects with known history of allergy considered due to Botulinum toxin type A
* Subjects who have received botulinum toxin A type within 3 months
* Any disease that might affect neuromuscular function (e.g.. Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis ect.)
* Subjects who are participating in other clinical trials
* Pregnant or lactating female Subjects
* Subjects who are not eligible for the study at the discretion of the Investigator.
```

## Arms

- **Botulinum toxin type A(Meditoxin®)** (EXPERIMENTAL)

## Interventions

- **Botulinum Toxin Type A** (DRUG) — 2 times, Intra-muscular injection, Maximum dosage total 60U

## Primary Outcomes

- **the change rate of Jankovic Rating Scale score** _(time frame: 4weeks)_ — To evaluate the change of JRS(Jankovic Rating Scale) score at 4 weeks post treatment based on baseline( 0 week).

## Secondary Outcomes

- **the change rate of Jankovic Rating Scale scale** _(time frame: 0 week, 16weeks(or retreatment point))_
- **the change rate of Blepharospasm Disability Index** _(time frame: 0week, 4weeks, 8weeks, 16weeks(or retreatment point))_
- **Global assessment about the improvement** _(time frame: 4weeks)_
- **the duration of efficacy** _(time frame: retreatment point or 16 weeks)_

## Locations (3)

- Sevrance Hospital, Seoul, South Korea
- Seoul St.Mary Hospital, Seoul, South Korea
- Chung-Ang Univesity Yongsan Hospital, Seoul, South Korea

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.sevrance hospital|seoul||south korea` — added _(2026-05-12)_
- `locations.seoul st.mary hospital|seoul||south korea` — added _(2026-05-12)_
- `locations.chung-ang univesity yongsan hospital|seoul||south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01259557.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01259557*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*