A prospective multi-centric, randomised, double-dummy, double- blind, placebo-controlled 3-way Phase III study to investigate the efficacy and safety of two dexamfetamine sulfate formulations in adults with ADHD - DEXINA -

Conditions

Patients with ADHD (according to ICD-10 / DSM-5)

Brief summary

The two primary endpoint families will be tested in hierarchical order separately for the respectiv test of • DEX IR tablets versus Placebo • DEX XL capsules versus Placebo, 1.1a Change in the total score of the ADHS-DC-Q at the end of the Optimal Stable Dose Phase (Visit 5) compared to baseline (Visit 0), 1.1b Change in the total score of the SDS at the end of the Optimal Stable Dose Phase (Visit 5) compared to baseline (Visit 0), 1.2 Treatment failure defined as:- Percentage change of at least 30% in the total score of the ADHS-DC-Q scale at the end of the LTFU / Withdrawal Phase compared to the beginning of the LTFU / Withdrawal Phase (Visit 5) - 2. Percentage change greater than -30% in the total score of the ADHS-DC-Q scale at the end of the LTFU / Withdrawal Phase (Visit 9) compared to baseline (Visit 0)

Detailed description

CGI-I Score at the end of the Optimal Stable Dose Phase (Visit 5), Change in CGI-S Score at the end of the Optimal Stable Dose Phase (Visit 5) and EOT (Visit 9) compared to baseline (Visit 0)

Related papers

No related papers found yet.

Interventions

DRUGDexamfetamine sulfate 10 mg modified-release capsule

DRUGPlacebo for test 2 - 20 mg

DRUGPlacebo for test 2 - 10 mg

DRUGPlacebo for test 2 - 15 mg

DRUGDexamfetamine sulfate 20 mg modified-release capsule

DRUGPlacebo for test 1 - 10 mg

DRUGAttentin 10 mg Tablette

DRUGAttentin 5 mg

DRUGTablette

DRUGPlacebo for Test 1 - 5 mg

DRUGDexamfetamine sulfate 15 mg modified-release capsule

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The two primary endpoint families will be tested in hierarchical order separately for the respectiv test of • DEX IR tablets versus Placebo • DEX XL capsules versus Placebo, 1.1a Change in the total score of the ADHS-DC-Q at the end of the Optimal Stable Dose Phase (Visit 5) compared to baseline (Visit 0), 1.1b Change in the total score of the SDS at the end of the Optimal Stable Dose Phase (Visit 5) compared to baseline (Visit 0), 1.2 Treatment failure defined as:- Percentage change of at least 30% in the total score of the ADHS-DC-Q scale at the end of the LTFU / Withdrawal Phase compared to the beginning of the LTFU / Withdrawal Phase (Visit 5) - 2. Percentage change greater than -30% in the total score of the ADHS-DC-Q scale at the end of the LTFU / Withdrawal Phase (Visit 9) compared to baseline (Visit 0)	—

Measure

Time frame

The two primary endpoint families will be tested in hierarchical order separately for the respectiv test of • DEX IR tablets versus Placebo • DEX XL capsules versus Placebo, 1.1a Change in the total score of the ADHS-DC-Q at the end of the Optimal Stable Dose Phase (Visit 5) compared to baseline (Visit 0), 1.1b Change in the total score of the SDS at the end of the Optimal Stable Dose Phase (Visit 5) compared to baseline (Visit 0), 1.2 Treatment failure defined as:- Percentage change of at least 30% in the total score of the ADHS-DC-Q scale at the end of the LTFU / Withdrawal Phase compared to the beginning of the LTFU / Withdrawal Phase (Visit 5) - 2. Percentage change greater than -30% in the total score of the ADHS-DC-Q scale at the end of the LTFU / Withdrawal Phase (Visit 9) compared to baseline (Visit 0)

—

Secondary

Measure	Time frame
CGI-I Score at the end of the Optimal Stable Dose Phase (Visit 5), Change in CGI-S Score at the end of the Optimal Stable Dose Phase (Visit 5) and EOT (Visit 9) compared to baseline (Visit 0)	—

Countries

Germany

Outcome results

None listed