Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP)

Bioprojet

Status and phase: Completed; Phase 3

Conditions: Excessive Daytime Sleepiness; Narcolepsy With Cataplexy

Treatments: Drug: Pitolisant; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01800045

2012-003076-39 (EudraCT Number)

P11-05 / Pitolisant

Details and patient eligibility

About

Double blind, randomized, parallel groups study of Pitolisant versus placebo, in narcoleptic patients experiencing EDS, and cataplexy (minimum of 3 complete or partial cataplexy attacks per week).

The patients will be treated during 7 weeks with Pitolisant or placebo.

Full description

The treatment period (7 weeks double blind) will aim at demonstrating the efficacy of Pitolisant on the number of cataplexy attacks and the Excessive Daytime Sleepiness by verifying whether the results of Pitolisant are superior to those of placebo.

The safety will also be assessed.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Narcoleptic with cataplexy : at least 3 weekly cataplexy attacks
• ESS > or = 12
• ICF signed and dated

Main Exclusion Criteria:

• Other conditions that could generate EDS
• Psychological and neurological disorders
• Acute or chronic severe disease
• Treatment by prohibited medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

103 participants in 2 patient groups, including a placebo group

Pitolisant

Experimental group

Description:

Pitolisant at 5, 10, 20 or 40mg

Treatment:

Drug: Pitolisant

Placebo

Placebo Comparator group

Description:

Capsules of placebo containing lactose

Treatment:

Drug: Placebo