Clinical trial of (+)-α-dihydrotetrabenazine in patients with moderate to severe tardive dyskinesia with open-label Part I and randomized, double-blind, placebo-controlled Part II.

Conditions

Tardive dyskinesia

Brief summary

Change in AIMS score (items 1 through 7) from Baseline (Day 0) to Week 12, as assessed by central rating.

Detailed description

Part I Secondary Endpoints: - Change in AIMS score (items 1 through 7) from Baseline (Day 0) to Week 12) in Part I, as assessed by the on-site Investigator. - Change in AIMS score (items 1 through 7 from Baseline (Day 0) to Week 9 in Part I, as assessed by the on-site Investigator. - Change in AIMS score (items 1 through 7) from Week 6 to Week 12 in Part I, as assessed by the on-site Investigator., Part II Secondary Endpoints: - Dose level associated with adequate control of dyskinesia (defined as dose level used in Maintenance period) in Part II. - Proportion of subjects with the value of Much or Very Much Improved on the Clinical Global Impression of Change (CGIC) at Week 12 in Part II. - Proportion of subjects with the value of Much or Very Much Improved on the Patient Global Impression of Change (PGIC) at Week 12 in Part II.

Related papers

No related papers found yet.

Interventions

DRUG(+)-α-DIHYDROTETRABENAZINE

DRUGADE513 placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in AIMS score (items 1 through 7) from Baseline (Day 0) to Week 12, as assessed by central rating.	—

Secondary

Measure	Time frame
Part I Secondary Endpoints: - Change in AIMS score (items 1 through 7) from Baseline (Day 0) to Week 12) in Part I, as assessed by the on-site Investigator. - Change in AIMS score (items 1 through 7 from Baseline (Day 0) to Week 9 in Part I, as assessed by the on-site Investigator. - Change in AIMS score (items 1 through 7) from Week 6 to Week 12 in Part I, as assessed by the on-site Investigator., Part II Secondary Endpoints: - Dose level associated with adequate control of dyskinesia (defined as dose level used in Maintenance period) in Part II. - Proportion of subjects with the value of Much or Very Much Improved on the Clinical Global Impression of Change (CGIC) at Week 12 in Part II. - Proportion of subjects with the value of Much or Very Much Improved on the Patient Global Impression of Change (PGIC) at Week 12 in Part II.	—

Measure

Time frame

Part I Secondary Endpoints: - Change in AIMS score (items 1 through 7) from Baseline (Day 0) to Week 12) in Part I, as assessed by the on-site Investigator. - Change in AIMS score (items 1 through 7 from Baseline (Day 0) to Week 9 in Part I, as assessed by the on-site Investigator. - Change in AIMS score (items 1 through 7) from Week 6 to Week 12 in Part I, as assessed by the on-site Investigator., Part II Secondary Endpoints: - Dose level associated with adequate control of dyskinesia (defined as dose level used in Maintenance period) in Part II. - Proportion of subjects with the value of Much or Very Much Improved on the Clinical Global Impression of Change (CGIC) at Week 12 in Part II. - Proportion of subjects with the value of Much or Very Much Improved on the Patient Global Impression of Change (PGIC) at Week 12 in Part II.

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Countries

Czechia, Hungary, Poland, Slovakia

Outcome results

None listed