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Clinical Trials/EUCTR2006-001039-23-IT
EUCTR2006-001039-23-IT
Active, Not Recruiting
N/A

A Pilot Phase II Study for the evaluation of efficacy and tolerability of Gammaidroxybutyrate (ALCOVER) administered by oral route as add on treatmant in patients affected by DYT 11 Myoclonic Dystonia. - ND

ISTITUTO NEUROLOGICO CARLO BESTA0 sitesSeptember 10, 2007
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DrugsALCOVER*OS SOLUZ 140ML 17,5%

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
ISTITUTO NEUROLOGICO CARLO BESTA
Status
Active, Not Recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 10, 2007
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ISTITUTO NEUROLOGICO CARLO BESTA

Eligibility Criteria

Inclusion Criteria

  • •Male and females \> 17 years. Diagnosis of myoclonic dystonia genetically confirmed (mutation of epsilon sarcoglycan gene, 7q21\-q31; DYT 11\). Refractory to treatment with conventional medications. No contraindications to GHB. Written informed consent.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Serious medical and/or psychiatric diseases. More than two concomitant medications for myoclonic dystonia therapy and/or modifications of concomitant therapy in the last month prior to basal visit. Alcohol or drug abuse (last 2 years). Pregnant or lactating females. Subjects who received an experimantal drug or have participated in a clinical trial within 3 months prior to screening.

Outcomes

Primary Outcomes

Not specified

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