Pilot Efficacy Study of T2000 in Myoclonus Dystonia

• Status: Terminated
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This pilot study will evaluate the safety and efficacy of once daily T2000 when used to treat patients with Myoclonus Dystonia over a 12 week period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taro Pharmaceuticals USA

Criteria

Inclusion Criteria:

• Patients should meet diagnostic criteria for M-D based on the following criteria:

• myoclonus is the primary feature; focal or segmental dystonia of any severity may also be present

• symptoms began by age 20

• a familial pattern should be present

• neurological history should not be suggestive of a different neurological condition

• investigations such as imaging, EEG and evoked potential tests should be normal

• Patients will be eligible for this study if they are symptomatic on their current treatment, cannot tolerate current therapies, or are treatment naïve patients who have been explained treatment alternatives.

Exclusion Criteria:

• Patients adequately controlled without side effects on a current M-D treatment

• Current treatment with a barbiturate such as phenobarbital or primidone

• Pregnant patients or patients who may become pregnant during the study

• Patients who must take medications that alter liver metabolism as well as patients with liver disease or coagulation disorders

• Patients with seizure disorders

• Patients with a history of allergy or hypersensitivity reaction to barbiturates or other related medications, such as phenobarbital or phenytoin

• Patient with significant general medical or clinical laboratory abnormalities