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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003076-39 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitolisant | Experimental | Pitolisant at 5, 10, 20 or 40mg |
|
| Placebo | Placebo Comparator | Capsules of placebo containing lactose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitolisant | Drug | 1 capsule in the morning before breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure of anticataplectic efficacy | Measure of anticataplectic efficacy assessed by the change in the average number of cataplexy attacks per week. | At week 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Excessive Daytime Sleepiness assessment | Excessive Daytime Sleepiness assessment by evaluation of ESS score, and other questionnaires. | At week 7 |
| Safety assessment | Safety assessment thanks to AE recording, vitals signs assessment, ECG... |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evelyne De Paillette, Dr | Bioprojet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Health Center | Budapest | 1134 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34935103 | Derived | Meskill GJ, Davis CW, Zarycranski D, Doliba M, Schwartz JC, Dayno JM. Clinical Impact of Pitolisant on Excessive Daytime Sleepiness and Cataplexy in Adults With Narcolepsy: An Analysis of Randomized Placebo-Controlled Trials. CNS Drugs. 2022 Jan;36(1):61-69. doi: 10.1007/s40263-021-00886-x. Epub 2021 Dec 21. | |
| 34822113 | Derived |
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| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| D006970 | Disorders of Excessive Somnolence |
| D002385 | Cataplexy |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C516975 | pitolisant |
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| Placebo | Drug | 1 capsule in the morning before breakfast |
|
|
| 11 weeks |
| Watson NF, Davis CW, Zarycranski D, Vaughn B, Dayno JM, Dauvilliers Y, Schwartz JC. Time to Onset of Response to Pitolisant for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Patients With Narcolepsy: An Analysis of Randomized, Placebo-Controlled Trials. CNS Drugs. 2021 Dec;35(12):1303-1315. doi: 10.1007/s40263-021-00866-1. Epub 2021 Nov 25. |
| 28129985 | Derived | Szakacs Z, Dauvilliers Y, Mikhaylov V, Poverennova I, Krylov S, Jankovic S, Sonka K, Lehert P, Lecomte I, Lecomte JM, Schwartz JC; HARMONY-CTP study group. Safety and efficacy of pitolisant on cataplexy in patients with narcolepsy: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017 Mar;16(3):200-207. doi: 10.1016/S1474-4422(16)30333-7. Epub 2017 Jan 25. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |