Efficacy Trial of Zonisamide for Myoclonus Dystonia

NCT01806805 | Completed Phase 3 DMC

• 1 other identifier: P091104
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Myoclonus Dystonia is a disease in which myoclonus distort the precision of movements and so cause a handicap in the movements of the everyday life. Response to oral medications may be incomplete and surgery may cause operating risk. Zonisamide is an antiepileptic drug which could bring a therapeutic profit in Myoclonus Dystonia on the severity of the myoclonus.

Conditions

Myoclonus Dystonia

Keywords

Movement disorder; Myoclonus dystonia; DYT 11; Antiepileptic drugs; Zonisamide; Clinical Trial; Double-mind method

Outcome Measures

Primary Outcomes (1)

• Measure of the evolution of the severity of myoclonus by a specific scale (UMRS)

  from day 0 to week 23

Secondary Outcomes (2)

• Measure of the evolution of the severity of dystonia by a specific scale (BFM)

  from day 0 to week 23

• measure of the evolution of the severity of myoclonus by electromyographic recording

  from day 0 to week 23

Study Arms (2)

Zonegran

EXPERIMENTAL

Zonegran / Placebo Zonisamide (Zonegran ®) and its placebo appear under the shape of virgin capsules of size 1. Each drug will be dispensed successively in a box containing blister packs of 14 capsules. For every period (A and B), box will contain 26 blister packs. A phase of progressive increase of doses by stages of 50 mg / week is planned before reaching the fixed dose of 300 in the daytime during 4 weeks. Then, a progressive diminution over two weeks is planned before the stop.

Drug: zonegran; Drug: placebo

placebo

PLACEBO COMPARATOR

Placebo /Experimental Zonisamide (Zonegran ®) and its placebo appear under the shape of virgin capsules of size 1. Each drug will be dispensed successively in a box containing blister packs of 14 capsules. For every period (A and B), box will contain 26 blister packs. A phase of progressive increase of doses by stages of 50 mg / week is planned before reaching the fixed dose of 300 in the daytime during 4 weeks. Then, a progressive diminution over two weeks is planned before the stop.

Drug: zonegran; Drug: placebo

Interventions

zonegran DRUG

Zonegran; placebo

placebo DRUG

Zonegran; placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age \>18 and \< 60
• Diagnosis of myoclonus dystonia including the isolated myoclonus caused by epsilon-sarcoglycans mutation or deletion.
• Myoclonus present in both hands
• Myoclonus decrease quality of life
• Insufficient efficiency of the benzodiazepine's tolerated maximal dose during one year
• Agreement to use a medically acceptable method of contraception throughout the study for female of childbearing potential
• Normal physical and neurological examination, except myoclonus dystonia
• No hepatic disease
• No renal disease
• Able to comply with study visits and procedures
• Has voluntarily signed consent form
• Taking no medications or stable doses medication for 4 weeks prior to the Baseline visit

You may not qualify if:

• Patients who are not enrolled at social security
• Individual who have MMS ≤ 24/30 or patients legally protected or inability to provide an informed consent
• Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control
• Weight \< 40 kg
• history of serious psychiatric illness
• history of renal stones
• history of allergy to sulfonamides
• taking medications : topiramate, rifampicin, ketoconazole, cimetidine

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pitié salpetriere hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Myoclonic dystonia; Movement Disorders

Interventions

Zonisamide

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Emmanuel Roze

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 7, 2013
• Study Start: February 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 24, 2015

Record last verified: 2015-04

Locations

FR (1)